Waldemar A Carlo

Publications (106)786.62 Total impact

• Article: Histological Characteristics of the Fetal Inflammatory Response Associated with Neurodevelopmental Impairment and Death in Extremely Preterm Infants.

  Ariel A Salas, Ona M Faye-Petersen, Brian Sims, Myriam Peralta-Carcelen, Stephanie D Reilly, Gerald McGwin, Waldemar A Carlo, Namasivayam Ambalavanan
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE: To test the hypothesis that increasing severity of the fetal inflammatory response (FIR) would have a dose-dependent relationship with severe neurodevelopmental impairment or death in extremely preterm infants. STUDY DESIGN: We report 347 infants of 23-28 weeks gestational age admitted to a tertiary neonatal intensive care unit between 2006 and 2008. The primary outcome was death or neurodevelopmental impairment at the 18- to 22-month follow-up. Exposure status was defined by increasing stage of funisitis (stage 1, phlebitis; stage 2, arteritis with or without phlebitis; stage 3, subacute necrotizing funisitis) and severity of chorionic plate vasculitis (inflammation with or without thrombosis). RESULTS: A FIR was detected in 110 placentas (32%). The rate of severe neurodevelopmental impairment/death was higher in infants with subacute necrotizing funisitis compared with infants without placental/umbilical cord inflammation (60% vs 35%; P < .05). Among infants with stage 1 or 2 funisitis, the presence of any chorionic vasculitis was associated with a higher rate of severe neurodevelopmental impairment/death (47% vs 23%; P < .05). After adjustment for confounding factors, only subacute necrotizing funisitis (risk ratio, 1.87; 95% CI, 1.04-3.35; P = .04) and chorionic plate vasculitis with thrombosis (risk ratio, 2.21; 95% CI, 1.10-4.46; P = .03) were associated with severe neurodevelopmental impairment/death. CONCLUSION: Severe FIR, characterized by subacute necrotizing funisitis and severe chorionic plate vasculitis with thrombosis, is associated with severe neurodevelopmental impairment/death in preterm infants.
  The Journal of pediatrics 05/2013; · 4.02 Impact Factor
• Article: Extremely Low Birth Weight and Infant Mortality Rates in the United States.

  Carissa Lau, Namasivayam Ambalavanan, Hrishikesh Chakraborty, Martha S Wingate, Waldemar A Carlo
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE:Infant mortality rates (IMR) and neonatal mortality rates (NMR) in the United States have not decreased recently. The purpose of this study was to determine the contributions of birth weight and gestational age subgroups to the IMR and NMR in the United States.METHODS:We used the most recent (1983-2005) US linked birth and infant death data and simple regression analysis to determine the contributions of specific birth weight and gestational age subgroups to trends in IMR and NMR.RESULTS:IMR and NMR decreased between 1983 and 2005 for all birth weight and gestational age subgroups. There was an increase in births of very low birth weight infants from 1.2% to 1.5% (P < .001) over this period. The proportion of very low birth weight-infant deaths increased from 42.9% to 54.8%, resulting in recent nonsignificant declines in IMR and NMR. The proportion of live-birth infants <500 g increased from 0.12% to 0.18% (P < .001). The adjusted IMR and NMR over time (excluding infants <500 g) have steeper declining trends than the ones including infants <500 g. The changes in overall IMR and NMR in recent years (2000-2005) are not statistically significant. However, the adjusted IMR and NMR trends during this time are highly significant.CONCLUSIONS:The increased proportions of infants <500 g and other low birth weight infants contribute greatly to the lack of a decrease in IMR and NMR from 2000 to 2005, although birth weight- and gestational age-specific IMR and NMR continue to decrease.
  PEDIATRICS 04/2013; · 4.47 Impact Factor
• Article: Perinatal Outcomes of Multiple-Gestation Pregnancies in Kenya, Zambia, Pakistan, India, Guatemala, and Argentina: A Global Network Study.

  Irene Marete, Constance Tenge, Omrana Pasha, Shivaprasad Goudar, Elwyn Chomba, Archana Patel, Fernando Althabe, Ana Garces, Elizabeth M McClure, Sarah Saleem, [......], Patricia L Hibberd, Nancy Krebs, Pierre Buekens, Robert L Goldenberg, Waldemar A Carlo, Dennis Wallace, Janet Moore, Marion Koso-Thomas, Linda L Wright, Edward A Liechty
  [show abstract] [hide abstract]
  ABSTRACT: Aim To determine the rates of multiple gestation, stillbirth, and perinatal and neonatal mortality and to determine health care system characteristics related to perinatal mortality of these pregnancies in low- and middle-income countries.Methods Pregnant women residing within defined geographic boundaries located in six countries were enrolled and followed to 42 days postpartum.Results Multiple gestations were 0.9% of births. Multiple gestations were more likely to deliver in a health care facility compared with singletons (70 and 66%, respectively, p < 0.001), to be attended by skilled health personnel (71 and 67%, p < 0.001), and to be delivered by cesarean (18 versus 9%, p < 0.001). Multiple-gestation fetuses had a relative risk (RR) for stillbirth of 2.65 (95% confidence interval [CI] 2.06, 3.41) and for perinatal mortality rate (PMR) a RR of 3.98 (95% CI 3.40, 4.65) relative to singletons (both p < 0.0001). Neither delivery in a health facility nor the cesarean delivery rate was associated with decreased PMR. Among multiple-gestation deliveries, physician-attended delivery relative to delivery by other health providers was associated with a decreased risk of perinatal mortality.Conclusions Multiple gestations contribute disproportionately to PMR in low-resource countries. Neither delivery in a health facility nor the cesarean delivery rate is associated with improved PMR.
  American Journal of Perinatology 03/2013; · 1.32 Impact Factor
• Article: Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities.

  Albert Manasyan, Sarah Saleem, Marion Koso-Thomas, Fernando Althabe, Omrana Pasha, Elwyn Chomba, Shivaprasad S Goudar, Archana Patel, Fabian Esamai, Ana Garces, [......], Elizabeth M McClure, Richard J Derman, Patricia Hibberd, Edward A Liechty, K Michael Hambidge, Waldemar A Carlo, Pierre Buekens, Janet Moore, Linda L Wright, Robert L Goldenberg
  [show abstract] [hide abstract]
  ABSTRACT: Objective To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality.Study Design In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/medications, and procedures including cesarean section.Results The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals.Conclusions Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.
  American Journal of Perinatology 01/2013; · 1.32 Impact Factor
• Source

  Available from: Juliann M Difiore

  Dataset: Low oxygen saturatino target range is associated with increased incidence of intermittent hypoxemia

  Juliann M Di Fiore, Michele Walsh, Lisa Wrage, Wade Rich, Neil Finer, Waldemar A Carlo, Richard J Martin
• Article: Early Sepsis Does Not Increase the Risk of Late Sepsis in Very Low Birth Weight Neonates.

  James L Wynn, Nellie I Hansen, Abhik Das, C Michael Cotten, Ronald N Goldberg, Pablo J Sánchez, Edward F Bell, Krisa P Van Meurs, Waldemar A Carlo, Abbot R Laptook, Rosemary D Higgins, Daniel K Benjamin, Barbara J Stoll
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE: To examine whether preterm very low birth weight (VLBW) infants have an increased risk of late-onset sepsis (LOS) following early-onset sepsis (EOS). STUDY DESIGN: Retrospective analysis of VLBW infants (401-1500 g) born September 1998 through December 2009 who survived >72 hours and were cared for within the National Institute of Child Health and Human Development Neonatal Research Network. Sepsis was defined by growth of bacteria or fungi in a blood culture obtained ≤72 hours of birth (EOS) or >72 hours (LOS) and antimicrobial therapy for ≥5 days or death <5 days while receiving therapy. Regression models were used to assess risk of death or LOS by 120 days and LOS by 120 days among survivors to discharge or 120 days, adjusting for gestational age and other covariates. RESULTS: Of 34 396 infants studied, 504 (1.5%) had EOS. After adjustment, risk of death or LOS by 120 days did not differ overall for infants with EOS compared with those without EOS [risk ratio (RR): 0.99 (0.89-1.09)] but was reduced in infants born at <25 weeks gestation [RR: 0.87 (0.76-0.99), P = .048]. Among survivors, no difference in LOS risk was found overall for infants with versus without EOS [RR: 0.88 (0.75-1.02)], but LOS risk was shorter in infants with birth weight 401-750 g who had EOS [RR: 0.80 (0.64-0.99), P = .047]. CONCLUSIONS: Risk of LOS after EOS was not increased in VLBW infants. Surprisingly, risk of LOS following EOS appeared to be reduced in the smallest, most premature infants, underscoring the need for age-specific analyses of immune function.
  The Journal of pediatrics 01/2013; · 4.02 Impact Factor
• Article: Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial.

  Yvonne E Vaucher, Myriam Peralta-Carcelen, Neil N Finer, Waldemar A Carlo, Marie G Gantz, Michele C Walsh, Abbot R Laptook, Bradley A Yoder, Roger G Faix, Abhik Das, [......], Brenda Poindexter, Anna M Dusick, Elisabeth C McGowan, Richard A Ehrenkranz, Anna Bodnar, Charles R Bauer, Janell Fuller, T Michael O'Shea, Gary J Myers, Rosemary D Higgins
  [show abstract] [hide abstract]
  ABSTRACT: Previous results from our trial of early treatment with continuous positive airway pressure (CPAP) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia. A lower (vs. higher) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality. We now report longer-term results from our prespecified hypotheses. Using a 2-by-2 factorial design, we randomly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation (85 to 89% or 91 to 95%). The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age. The primary outcome was determined for 1234 of 1316 enrolled infants (93.8%); 990 of the 1058 surviving infants (93.6%) were evaluated at 18 to 22 months of corrected age. Death or neurodevelopmental impairment occurred in 27.9% of the infants in the CPAP group (173 of 621 infants), versus 29.9% of those in the surfactant group (183 of 613) (relative risk, 0.93; 95% confidence interval [CI], 0.78 to 1.10; P=0.38), and in 30.2% of the infants in the lower-oxygen-saturation group (185 of 612), versus 27.5% of those in the higher-oxygen-saturation group (171 of 622) (relative risk, 1.12; 95% CI, 0.94 to 1.32; P=0.21). Mortality was increased with the lower-oxygen-saturation target (22.1%, vs. 18.2% with the higher-oxygen-saturation target; relative risk, 1.25; 95% CI, 1.00 to 1.55; P=0.046). We found no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely premature infants randomly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute; SUPPORT ClinicalTrials.gov number, NCT00233324.).
  New England Journal of Medicine 12/2012; 367(26):2495-504. · 53.30 Impact Factor
• Article: Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries.

  Waldemar A Carlo, Shivaprasad S Goudar, Omrana Pasha, Elwyn Chomba, Jan L Wallander, Fred J Biasini, Elizabeth M McClure, Vanessa Thorsten, Hrishikesh Chakraborty, Dennis Wallace, Darlene L Shearer, Linda L Wright
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE: To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children. STUDY DESIGN: This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years starting the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history. RESULTS: MDI was higher in the EDI (102.6 ± 9.8) compared with the control resuscitated children (98.0 ± 14.6, 1-sided P = .0202), but there was no difference between groups in the nonresuscitated children (100.1 ± 10.7 vs 97.7 ± 10.4, P = .1392). The Psychomotor Development Index was higher in the EDI group for both the resuscitated (P = .0430) and nonresuscitated children (P = .0164). CONCLUSIONS: This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and Psychomotor Development Index scores of both nonresuscitated and resuscitated infants were within normal range, independent of early intervention.
  The Journal of pediatrics 11/2012; · 4.02 Impact Factor
• Article: Brain injury following trial of hypothermia for neonatal hypoxic-ischaemic encephalopathy.

  Seetha Shankaran, Patrick D Barnes, Susan R Hintz, Abbott R Laptook, Kristin M Zaterka-Baxter, Scott A McDonald, Richard A Ehrenkranz, Michele C Walsh, Jon E Tyson, Edward F Donovan, [......], Abhik Das, Neil N Finer, Pablo J Sanchez, Brenda B Poindexter, Krisa P Van Meurs, Waldemar A Carlo, Barbara J Stoll, Shahnaz Duara, Ronnie Guillet, Rosemary D Higgins
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE: The objective of our study was to examine the relationship between brain injury and outcome following neonatal hypoxic-ischaemic encephalopathy treated with hypothermia. DESIGN AND PATIENTS: Neonatal MRI scans were evaluated in the National Institute of Child Health and Human Development (NICHD) randomised controlled trial of whole-body hypothermia and each infant was categorised based upon the pattern of brain injury on the MRI findings. Brain injury patterns were assessed as a marker of death or disability at 18-22 months of age. RESULTS: Scans were obtained on 136 of 208 trial participants (65%); 73 in the hypothermia and 63 in the control group. Normal scans were noted in 38 of 73 infants (52%) in the hypothermia group and 22 of 63 infants (35%) in the control group. Infants in the hypothermia group had fewer areas of infarction (12%) compared to infants in the control group (22%). Fifty-one of the 136 infants died or had moderate or severe disability at 18 months. The brain injury pattern correlated with outcome of death or disability and with disability among survivors. Each point increase in the severity of the pattern of brain injury was independently associated with a twofold increase in the odds of death or disability. CONCLUSIONS: Fewer areas of infarction and a trend towards more normal scans were noted in brain MRI following whole-body hypothermia. Presence of the NICHD pattern of brain injury is a marker of death or moderate or severe disability at 18-22 months following hypothermia for neonatal encephalopathy.
  Archives of Disease in Childhood - Fetal and Neonatal Edition 11/2012; 97(6):F398-F404. · 3.05 Impact Factor
• Article: Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol.

  Fernando Althabe, José M Belizán, Agustina Mazzoni, Mabel Berrueta, Jay Hemingway-Foday, Marion Koso-Thomas, Elizabeth McClure, Elwyn Chomba, Ana Garces, Shivaprasad Goudar, [......], Waldemar A Carlo, Nancy F Krebs, Richard J Derman, Robert L Goldenberg, Patricia Hibberd, Edward A Liechty, Linda L Wright, Eduardo F Bergel, Alan H Jobe, Pierre Buekens
  [show abstract] [hide abstract]
  ABSTRACT: BACKGROUND: Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births. METHODS: We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT01084096.
  Reproductive Health 09/2012; 9:22.
• Article: Randomized controlled trial of meat compared with multimicronutrient-fortified cereal in infants and toddlers with high stunting rates in diverse settings.

  Nancy F Krebs, Manolo Mazariegos, Elwyn Chomba, Neelofar Sami, Omrana Pasha, Antoinette Tshefu, Waldemar A Carlo, Robert L Goldenberg, Carl L Bose, Linda L Wright, [......], Norman Goco, Mark Kindem, Elizabeth M McClure, Jamie Westcott, Ana Garces, Adrien Lokangaka, Albert Manasyan, Edna Imenda, Tyler D Hartwell, K Michael Hambidge
  [show abstract] [hide abstract]
  ABSTRACT: Improved complementary feeding is cited as a critical factor for reducing stunting. Consumption of meats has been advocated, but its efficacy in low-resource settings has not been tested. The objective was to test the hypothesis that daily intake of 30 to 45 g meat from 6 to 18 mo of age would result in greater linear growth velocity and improved micronutrient status in comparison with an equicaloric multimicronutrient-fortified cereal. This was a cluster randomized efficacy trial conducted in the Democratic Republic of Congo, Zambia, Guatemala, and Pakistan. Individual daily portions of study foods and education messages to enhance complementary feeding were delivered to participants. Blood tests were obtained at trial completion. A total of 532 (86.1%) and 530 (85.8%) participants from the meat and cereal arms, respectively, completed the study. Linear growth velocity did not differ between treatment groups: 1.00 (95% CI: 0.99, 1.02) and 1.02 (95% CI: 1.00, 1.04) cm/mo for the meat and cereal groups, respectively (P = 0.39). From baseline to 18 mo, stunting [length-for-age z score (LAZ) <-2.0] rates increased from ∼33% to nearly 50%. Years of maternal education and maternal height were positively associated with linear growth velocity (P = 0.0006 and 0.003, respectively); LAZ at 6 mo was negatively associated (P < 0.0001). Anemia rates did not differ by group; iron deficiency was significantly lower in the cereal group. The high rate of stunting at baseline and the lack of effect of either the meat or multiple micronutrient-fortified cereal intervention to reverse its progression argue for multifaceted interventions beginning in the pre- and early postnatal periods. This trial was registered at clinicaltrials.gov as NCT01084109.
  American Journal of Clinical Nutrition 09/2012; 96(4):840-7. · 6.67 Impact Factor
• Article: Cytokines and Posthemorrhagic Ventricular Dilation in Premature Infants.

  Namasivayam Ambalavanan, Waldemar A Carlo, Scott A McDonald, Abhik Das, Diana E Schendel, Poul Thorsen, David M Hougaard, Kristin Skogstrand, Rosemary D Higgins
  [show abstract] [hide abstract]
  ABSTRACT: Objective To determine in extremely low-birth-weight infants if elevated blood interferon-γ (IFN-γ), interleukin (IL)-1β, IL-18, tumor necrosis factor-α (TNF-α), and transforming growth factor-β are associated with need for shunt following severe intraventricular hemorrhage (IVH) or with ventricular dilation following milder grades/no IVH.Study Design Whole blood cytokines were measured on postnatal days 1, 3, 7, 14, and 21. Maximum IVH grade in the first 28 days, and shunt surgery or ventricular dilation on subsequent ultrasound (28 days' to 36 weeks' postmenstrual age) were determined.Results Of 902 infants in the National Institute of Child Health and Human Development Neonatal Research Network Cytokine study who survived to 36 weeks or discharge, 3.1% had shunts. Of the 12% of infants with severe (grade III to IV) IVH, 26% had a shunt associated with elevated TNF-α. None of the infants without IVH (69%) or with grade I (12%) or II (7%) IVH received shunts, but 8.4% developed ventricular dilation, associated with lower IFN-γ and higher IL-18.Conclusion Statistically significant but clinically nondiscriminatory alterations in blood cytokines were noted in infants with severe IVH who received shunts and in those without severe IVH who developed ventricular dilation. Blood cytokines are likely associated with brain injury but may not be clinically useful as biomarkers for white matter damage.
  American Journal of Perinatology 07/2012; 29(9):731-740. · 1.32 Impact Factor
• Article: Low Oxygen Saturation Target Range is Associated with Increased Incidence of Intermittent Hypoxemia.

  Juliann M Di Fiore, Michele Walsh, Lisa Wrage, Wade Rich, Neil Finer, Waldemar A Carlo, Richard J Martin
  [show abstract] [hide abstract]
  ABSTRACT: OBJECTIVE: To test the hypothesis that preterm infants randomized to a low vs high O(2) saturation target range have a higher incidence of intermittent hypoxemia. STUDY DESIGN: A subcohort of 115 preterm infants with high resolution pulse oximetry enrolled in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial were randomized to low (85%-89%) or high (91%-95%) O(2) saturation target ranges. Oxygen saturation was monitored until 36 weeks postmenstrual age or until the infant was breathing room air without respiratory support for ≥72 hours. RESULTS: The low target O(2) saturation group had a higher rate of intermittent hypoxemia (≤80% for ≥10 seconds and ≤3 minutes) prior to 12 days and beyond 57 days of life (P < .05). The duration shortened (P < .0001) and the severity increased (P < .0001) with increasing postnatal age with no differences between target saturation groups. The higher rate of intermittent hypoxemia events in the low target group was associated with a time interval between events of <1 minute. CONCLUSION: A low O(2) saturation target was associated with an increased rate of intermittent hypoxemia events that was dependent on postnatal age. The duration and severity of events was comparable between target groups. Further investigation is needed to assess the role of intermittent hypoxemia and their timing on neonatal morbidity.
  The Journal of pediatrics 06/2012; · 4.02 Impact Factor
• Article: The Maternal and Newborn Health Registry Study of the Global Network for Women's and Children's Health Research.

  Shivaprasad S Goudar, Waldemar A Carlo, Elizabeth M McClure, Omrana Pasha, Archana Patel, Fabian Esamai, Elwyn Chomba, Ana Garces, Fernando Althabe, Bhalachandra Kodkany, [......], Edward A Liechty, Nancy F Krebs, K Michael Hambidge, Pierre Buekens, Janet Moore, Dennis Wallace, Alan H Jobe, Marion Koso-Thomas, Linda L Wright, Robert L Goldenberg
  [show abstract] [hide abstract]
  ABSTRACT: To implement a vital statistics registry system to register pregnant women and document birth outcomes in the Global Network for Women's and Children's Health Research sites in Asia, Africa, and Latin America. The Global Network sites began a prospective population-based pregnancy registry to identify all pregnant women and record pregnancy outcomes up to 42 days post-delivery in more than 100 defined low-resource geographic areas (clusters). Pregnant women were registered during pregnancy, with 42-day maternal and neonatal follow-up recorded-including care received during the pregnancy and postpartum periods. Recorded outcomes included stillbirth, neonatal mortality, and maternal mortality rates. In 2010, 72848 pregnant women were enrolled and 6-week follow-up was obtained for 97.8%. Across sites, 40.7%, 24.8%, and 34.5% of births occurred in a hospital, health center, and home setting, respectively. The mean neonatal mortality rate was 23 per 1000 live births, ranging from 8.2 to 48.5 per 1000 live births. The mean stillbirth rate ranged from 13.7 to 54.4 per 1000 births. The registry is an ongoing study to assess the impact of interventions and trends regarding pregnancy outcomes and measures of care to inform public health. ClinicalTrial.gov Trial Registration:NCT01073475.
  International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 06/2012; 118(3):190-3. · 1.41 Impact Factor
• Article: Elevated midtrimester α-fetoprotein and delivery markers of inflammation in a preterm population.

  Monique Ho, Ona M Faye-Petersen, Robert L Goldenberg, Waldemar A Carlo, Suzanne P Cliver, William W Andrews
  [show abstract] [hide abstract]
  ABSTRACT: Objective: Determine whether elevated second trimester maternal serum α-fetoprotein (AFP) is associated with clinical and histopathologic markers of inflammation at preterm delivery. Methods: 105 women <32 weeks' gestation were included. AFP levels were dichotomized at 2.0 multiples of the median (MoM). Rates of neonatal morbidities, clinical chorioamnionitis, cord blood IL-6 level, and placental inflammatory findings were compared. Results: Thirteen (12.4%) had elevated AFP. Fewer women with AFP ≥2 MoM had histologic placental or membrane rupture site inflammation, funisitis, or placental culture positive for Mycoplasma and Ureaplasma species, compared to those with normal AFP. Neonatal death was increased in the elevated AFP group (23.1% vs. 2.27%, RR 10.6). Elevated AFP was associated with a nonsignificant increase in indicated birth (54% vs. 35%; p = 0.225). Virtually all inflammatory findings were confined to the spontaneous delivery group. Conclusion: Elevated midtrimester AFP conveyed significant risk of neonatal death, but was negatively associated with clinical or histopathologic inflammation in preterm infants.
  The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 06/2012; 25(11):2424-7. · 1.36 Impact Factor
• Article: Outcome trajectories in extremely preterm infants.

  Namasivayam Ambalavanan, Waldemar A Carlo, Jon E Tyson, John C Langer, Michele C Walsh, Nehal A Parikh, Abhik Das, Krisa P Van Meurs, Seetha Shankaran, Barbara J Stoll, Rosemary D Higgins
  [show abstract] [hide abstract]
  ABSTRACT: Methods are required to predict prognosis with changes in clinical course. Death or neurodevelopmental impairment in extremely premature neonates can be predicted at birth/admission to the ICU by considering gender, antenatal steroids, multiple birth, birth weight, and gestational age. Predictions may be improved by using additional information available later during the clinical course. Our objective was to develop serial predictions of outcome by using prognostic factors available over the course of NICU hospitalization. Data on infants with birth weight ≤ 1.0 kg admitted to 18 large academic tertiary NICUs during 1998-2005 were used to develop multivariable regression models following stepwise variable selection. Models were developed by using all survivors at specific times during hospitalization (in delivery room [n = 8713], 7-day [n = 6996], 28-day [n = 6241], and 36-week postmenstrual age [n = 5118]) to predict death or death/neurodevelopmental impairment at 18 to 22 months. Prediction of death or neurodevelopmental impairment in extremely premature infants is improved by using information available later during the clinical course. The importance of birth weight declines, whereas the importance of respiratory illness severity increases with advancing postnatal age. The c-statistic in validation models ranged from 0.74 to 0.80 with misclassification rates ranging from 0.28 to 0.30. Dynamic models of the changing probability of individual outcome can improve outcome predictions in preterm infants. Various current and future scenarios can be modeled by input of different clinical possibilities to develop individual "outcome trajectories" and evaluate impact of possible morbidities on outcome.
  PEDIATRICS 06/2012; 130(1):e115-25. · 4.47 Impact Factor
• Article: Association Between Blood Spot Transforming Growth Factor-β and Patent Ductus Arteriosus in Extremely Low-Birth Weight Infants.

  Girija Natarajan, Seetha Shankaran, Scott A McDonald, Abhik Das, Richard A Ehrenkranz, Ronald N Goldberg, Barbara J Stoll, Jon E Tyson, Rosemary D Higgins, Diana Schendel, David M Hougaard, Kristin Skogstrand, Poul Thorsen, Waldemar A Carlo
  [show abstract] [hide abstract]
  ABSTRACT: Permanent ductal closure involves anatomic remodeling, in which transforming growth factor (TGF)-β appears to play a role. Our objective was to evaluate the relationship, if any, between blood spot TGF-β on day 3 and day 7 of life and patent ductus arteriosus (PDA) in extremely low birth weight (ELBW) infants. Prospective observational study involving ELBW infants (n = 968) in the National Institute of Child Health and Human Development Neonatal Research Network who had TGF-β measured on filter paper spot blood samples using a Luminex assay. Infants with a PDA (n = 493) were significantly more immature, had lower birth weights, and had higher rates of respiratory distress syndrome than those without PDA (n = 475). TGF-β on days 3 and 7 of life, respectively, were significantly lower among neonates with PDA (median 1,177 pg/ml [range 642-1,896]; median 1,386 pg/ml [range 868-1,913]) compared with others without PDA (median 1,334 pg/ml [range 760-2,064]; median 1,712 pg/ml [range 1,014-2,518 pg/ml]). The significant difference persisted when death or PDA was considered a composite outcome. TGF-β levels were not significantly different among subgroups of infants with PDA who were not treated (n = 51) versus those who were treated medically (n = 283) or by surgical ligation (n = 159). TGF-β was not a significant predictor of death or PDA (day 3 odds ratio [OR] 0.99, 95 % confidence interval [CI] 0.83-1.17; day 7 OR 0.88, 95 % CI 0.74-1.04) on adjusted analyses. Our results suggest that blood spot TGF-β alone is unlikely to be a reliable biomarker of a clinically significant PDA or its responsiveness to treatment.
  Pediatric Cardiology 06/2012; · 1.30 Impact Factor
• Article: Neonatal death in low- to middle-income countries: a global network study.

  José M Belizán, Elizabeth M McClure, Shivaprasad S Goudar, Omrana Pasha, Fabian Esamai, Archana Patel, Elwyn Chomba, Ana Garces, Linda L Wright, Marion Koso-Thomas, [......], Neelofar Sami, Albert Manasyan, Richard J Derman, Edward A Liechty, Patricia Hibberd, Waldemar A Carlo, K Michael Hambidge, Pierre Buekens, Alan H Jobe, Robert L Goldenberg
  [show abstract] [hide abstract]
  ABSTRACT: To determine population-based neonatal mortality rates in low- and middle-income countries and to examine gestational age, birth weight, and timing of death to assess the potentially preventable neonatal deaths. A prospective observational study was conducted in communities in five low-income countries (Kenya, Zambia, Guatemala, India, and Pakistan) and one middle-income country (Argentina). Over a 2-year period, all pregnant women in the study communities were enrolled by trained study staff and their infants followed to 28 days of age. Between October 2009 and March 2011, 153,728 babies were delivered and followed through day 28. Neonatal death rates ranged from 41 per 1000 births in Pakistan to 8 per 1000 in Argentina; 54% of the neonatal deaths were >37 weeks and 46% weighed 2500 g or more. Half the deaths occurred within 24 hours of delivery. In our population-based low- and middle-income country registries, the majority of neonatal deaths occurred in babies >37 weeks' gestation and almost half weighed at least 2500 g. Most deaths occurred shortly after birth. With access to better medical care and hospitalization, especially in the intrapartum and early neonatal period, many of these neonatal deaths might be prevented.
  American Journal of Perinatology 05/2012; 29(8):649-56. · 1.32 Impact Factor
• Article: Approach to infants born at 22 to 24 weeks' gestation: relationship to outcomes of more-mature infants.

  P Brian Smith, Namasivayam Ambalavanan, Lei Li, C Michael Cotten, Matthew Laughon, Michele C Walsh, Abhik Das, Edward F Bell, Waldemar A Carlo, Barbara J Stoll, Seetha Shankaran, Abbot R Laptook, Rosemary D Higgins, Ronald N Goldberg
  [show abstract] [hide abstract]
  ABSTRACT: We sought to determine if a center's approach to care of premature infants at the youngest gestational ages (22-24 weeks' gestation) is associated with clinical outcomes among infants of older gestational ages (25-27 weeks' gestation). Inborn infants of 401 to 1000 g birth weight and 22 0/7 to 27 6/7 weeks' gestation at birth from 2002 to 2008 were enrolled into a prospectively collected database at 20 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Markers of an aggressive approach to care for 22- to 24-week infants included use of antenatal corticosteroids, cesarean delivery, and resuscitation. The primary outcome was death before postnatal day 120 for infants of 25 to 27 weeks' gestation. Secondary outcomes were the combined outcomes of death or a number of morbidities associated with prematurity. Our study included 3631 infants 22 to 24 weeks' gestation and 5227 infants 25 to 27 weeks' gestation. Among the 22- to 24-week infants, use of antenatal corticosteroids ranged from 28% to 100%, cesarean delivery from 13% to 65%, and resuscitation from 30% to 100% by center. Centers with higher rates of antenatal corticosteroid use in 22- to 24-week infants had reduced rates of death, death or retinopathy of prematurity, death or late-onset sepsis, death or necrotizing enterocolitis, and death or neurodevelopmental impairment in 25- to 27-week infants. This study suggests that physicians' willingness to provide care to extremely low gestation infants as measured by frequency of use of antenatal corticosteroids is associated with improved outcomes for more-mature infants.
  PEDIATRICS 05/2012; 129(6):e1508-16. · 4.47 Impact Factor
• Article: Home birth attendants in low income countries: who are they and what do they do?

  Ana Garces, Elizabeth M McClure, Elwyn Chomba, Archana Patel, Omrana Pasha, Antoinette Tshefu, Fabian Esamai, Shivaprasad Goudar, Adrien Lokangaka, K Michael Hamidge, Linda L Wright, Marion Koso-Thomas, Carl Bose, Waldemar A Carlo, Edward A Liechty, Patricia L Hibberd, Sherri Bucher, Ryan Whitworth, Robert L Goldenberg
  [show abstract] [hide abstract]
  ABSTRACT: BACKGROUND: Nearly half the world's babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites. METHODS: Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or outof- facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia). RESULTS: A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home. CONCLUSIONS: Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.
  BMC Pregnancy and Childbirth 05/2012; 12(1):34. · 2.83 Impact Factor