Pablo J Sánchez

Nationwide Children's Hospital, Columbus, Ohio, United States

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Publications (155)903.53 Total impact

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    ABSTRACT: As part of the CMV and Hearing Multicenter Screening (CHIMES) study, 72,239 newborns were screened for cytomegalovirus by rapid culture and real-time PCR of saliva samples. Of the 266 infants with congenital cytomegalovirus infection, discordance between rapid culture and PCR was observed in 14 children, and 13 were identified only by PCR, demonstrating the superiority of the PCR assay.
    The Pediatric Infectious Disease Journal 05/2015; 34(5):536-7. DOI:10.1097/INF.0000000000000609 · 3.14 Impact Factor
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    ABSTRACT: This retrospective study characterized the clinical course of 13 neonates who died with herpes simplex virus infection from 2001 to 2011, representing a 26% case-fatality rate. Fatal disease developed at ≤48 hours of age in one-third of infants, was mostly disseminated disease, and occurred despite early administration of high-dose acyclovir therapy. Copyright © 2015 Elsevier Inc. All rights reserved.
    The Journal of pediatrics 04/2015; DOI:10.1016/j.jpeds.2015.03.004 · 3.74 Impact Factor
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    ABSTRACT: Background We previously reported on the overall incidence, management, and outcomes in infants with cardiovascular insufficiency (CVI). However, there are limited data on the relationship of the specific different definitions of CVI to short-term outcomes in term and late preterm newborn infants. Objective This study aims to evaluate how four definitions of CVI relate to short-term outcomes and death. Study Design The previously reported study was a multicenter, prospective cohort study of 647 infants ≥ 34 weeks gestation admitted to a Neonatal Research Network (NRN) newborn intensive care unit (NICU) and mechanically ventilated (MV) during their first 72 hours. The relationship of five short-term outcomes at discharge and four different definitions of CVI were further analyzed. Results All the four definitions were associated with greater number of days on MV and days on O2. The definition using a threshold blood pressure (BP) measurement alone was not associated with days of full feeding, days in the NICU or death. The definition based on the treatment of CVI was associated with all the outcomes including death. Conclusions The definition using a threshold BP alone was not consistently associated with adverse short-term outcomes. Using only a threshold BP to determine therapy may not improve outcomes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
    American Journal of Perinatology 03/2015; DOI:10.1055/s-0035-1547321 · 1.60 Impact Factor
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    ABSTRACT: The treatment of symptomatic congenital cytomegalovirus (CMV) disease with intravenous ganciclovir for 6 weeks has been shown to improve audiologic outcomes at 6 months, but the benefits wane over time. We conducted a randomized, placebo-controlled trial of valganciclovir therapy in neonates with symptomatic congenital CMV disease, comparing 6 months of therapy with 6 weeks of therapy. The primary end point was the change in hearing in the better ear ("best-ear" hearing) from baseline to 6 months. Secondary end points included the change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes, with each end point adjusted for central nervous system involvement at baseline. A total of 96 neonates underwent randomization, of whom 86 had follow-up data at 6 months that could be evaluated. Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group (2 and 3 participants, respectively, had improvement; 36 and 37 had no change; and 5 and 3 had worsening; P=0.41). Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language-composite component (P=0.004) and on the receptive-communication scale (P=0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P=0.64). Treating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00466817.).
    New England Journal of Medicine 03/2015; 372(10):933-43. DOI:10.1056/NEJMoa1404599 · 54.42 Impact Factor
  • Joseph B Cantey, Alan M Klein, Pablo J Sánchez
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    ABSTRACT: Polymerase chain reaction testing of blood for herpes simplex virus (HSV) is recommended for newborns delivered to mothers with active genital HSV lesions at delivery. We report an infant who had a positive blood HSV polymerase chain reaction test before the onset of clinical signs of HSV disease. Copyright © 2015 Elsevier Inc. All rights reserved.
    Journal of Pediatrics 02/2015; 166(5). DOI:10.1016/j.jpeds.2015.01.042 · 3.74 Impact Factor
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    ABSTRACT: Understanding the causes and timing of death in extremely premature infants may guide research efforts and inform the counseling of families. We analyzed prospectively collected data on 6075 deaths among 22,248 live births, with gestational ages of 22 0/7 to 28 6/7 weeks, among infants born in study hospitals within the National Institute of Child Health and Human Development Neonatal Research Network. We compared overall and cause-specific in-hospital mortality across three periods from 2000 through 2011, with adjustment for baseline differences. The number of deaths per 1000 live births was 275 (95% confidence interval [CI], 264 to 285) from 2000 through 2003 and 285 (95% CI, 275 to 295) from 2004 through 2007; the number decreased to 258 (95% CI, 248 to 268) in the 2008-2011 period (P=0.003 for the comparison across three periods). There were fewer pulmonary-related deaths attributed to the respiratory distress syndrome and bronchopulmonary dysplasia in 2008-2011 than in 2000-2003 and 2004-2007 (68 [95% CI, 63 to 74] vs. 83 [95% CI, 77 to 90] and 84 [95% CI, 78 to 90] per 1000 live births, respectively; P=0.002). Similarly, in 2008-2011, as compared with 2000-2003, there were decreases in deaths attributed to immaturity (P=0.05) and deaths complicated by infection (P=0.04) or central nervous system injury (P<0.001); however, there were increases in deaths attributed to necrotizing enterocolitis (30 [95% CI, 27 to 34] vs. 23 [95% CI, 20 to 27], P=0.03). Overall, 40.4% of deaths occurred within 12 hours after birth, and 17.3% occurred after 28 days. We found that from 2000 through 2011, overall mortality declined among extremely premature infants. Deaths related to pulmonary causes, immaturity, infection, and central nervous system injury decreased, while necrotizing enterocolitis-related deaths increased. (Funded by the National Institutes of Health.).
    New England Journal of Medicine 01/2015; 372(4):331-40. DOI:10.1056/NEJMoa1403489 · 54.42 Impact Factor
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    ABSTRACT: Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of >=15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary hypertension of the newborn (PPHN) may require novel study designs and a longer period of time from study approval to commencement of enrollment.Trial registration: ClinicalTrials.gov: Pilot one: NCT number: 00598429 https://clinicaltrials.gov/ct2/show/NCT00598429?term=PGE1&rank=5registered on 10 January 2008. Last updated: 3 February 2011.Pilot two: NCT number: 01467076 https://clinicaltrials.gov/ct2/show/NCT01467076?term=PGE1&rank=717 October 2011. Last updated: 13 February 2013.
    Trials 12/2014; 15(1):486. DOI:10.1186/1745-6215-15-486 · 2.12 Impact Factor
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    ABSTRACT: A non-standardized approach to caring for infants after pyloromyotomy for pyloric stenosis was associated with prolonged postoperative length of stay (pLOS) at our institution. We studied the impact of a standardized postoperative care protocol on pLOS, patients' clinical course, and nursing care. A retrospective chart review identified that 27% of infants who underwent uncomplicated pyloromyotomy had prolonged pLOS, defined as more than one postoperative midnight. A comprehensive postoperative care protocol was developed for infants undergoing pyloromyotomy. Patients were recruited prospectively and those with complications were excluded. A sample size of 70 in each cohort (historic and prospective) allowed 80% power to detect a 50% reduction in the proportion of patients with prolonged pLOS (α=0.05). The prospective group and historic cohort were compared using nonparametric statistics. The historic cohort had 70 patients and the prospective cohort had 66. Protocol implementation resulted in fewer patients with prolonged pLOS, shorter time to feeds, fewer feeds to discharge, less emesis, and improved nursing documentation. Implementation of a postoperative care protocol improved various aspects of patient care and nursing care studied. Protocols outline a patient's course and serve as a common platform for communication among care providers; they can facilitate, expedite, and enhance patient care. Copyright © 2014 Elsevier Inc. All rights reserved.
    Journal of Pediatric Surgery 12/2014; DOI:10.1016/j.jpedsurg.2014.12.019 · 1.31 Impact Factor
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    ABSTRACT: OBJECTIVE: Prophylactic indomethacin reduces severe intraventricular hemorrhage but may increase spontaneous intestinal perforation (SIP) in extremely low birth weight (ELBW) infants. Early feedings improve nutritional outcomes but may increase the risk of SIP. Despite their benefits, use of these therapies varies largely by physician preferences in part because of the concern for SIP. METHODS: This was a cohort study of 15 751 ELBW infants in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network from 1999 to 2010 who survived beyond 12 hours after birth. The risk of SIP was compared between groups of infants with and without exposure to prophylactic indomethacin and early feeding in unadjusted analyses and in analyses adjusted for center and for risks of SIP. RESULTS: Among infants exposed to prophylactic indomethacin, the risk of SIP did not differ between the indomethacin/early-feeding group compared with the indomethacin/no-early-feeding group (adjusted relative risk [RR] 0.74, 95% confidence interval [CI] 0.49-1.11). The risk of SIP was lower in the indomethacin/early-feeding group compared with the no indomethacin/no-early-feeding group (adjusted RR 0.58, 95% CI 0.37-0.90, P = .0159). Among infants not exposed to indomethacin, early feeding was associated with a lower risk of SIP compared with the no early feeding group (adjusted RR 0.53, 95% CI 0.36-0.777, P = .0011). CONCLUSIONS: The combined or individual use of prophylactic indomethacin and early feeding was not associated with an increased risk of SIP in ELBW infants.
    Pediatrics 10/2014; 134(5). DOI:10.1542/peds.2014-0183 · 5.30 Impact Factor
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    ABSTRACT: Background: Congenital CMV infection is a leading cause of sensorineural hearing loss (SNHL) and neurodevelopmental impairment in childhood. Information on CMV detection in cerebrospinal fluid (CSF) and its association with outcomes is limited. The objective of this study was to determine the significance of CMV detection in CSF of infants with congenital CMV infection. Methods: Retrospective review of cases of congenital CMV infection diagnosed at Nationwide Children’s Hospital, Parkland Memorial Hospital/Children’s Medical Center Dallas, and the University of Oklahoma Health Sciences Center from 1996-2014. Diagnosis of congenital CMV was made by culture or PCR from urine or saliva within the first 3 weeks of age. Detection of CMV in CSF was performed by culture or PCR. Clinical, laboratory, radiographic, and audiologic data was reviewed. Infants in whom CMV was detected in CSF were compared to those whose CSF was negative for CMV. Results: Twenty-two infants with congenital CMV infection who had a lumbar puncture performed and CSF tested for CMV were enrolled. All 22 infants had clinically apparent ("symptomatic") disease. 10 (45%) infants had CMV detected in CSF (CSF+) and were compared to the 12 infants whose CSF was CMV-negative (CSF-). The CSF+ infants did not differ from those whose CSF was CMV negative (CMV-) in age at diagnosis (median/range; 1.5 [1-8] vs.1 [1-17]; p>0.05), platelet count (p=0.47), alanine aminotransferase (p=0.11), direct bilirubin concentration (p=0.08), or CSF analyses including white blood cell count (p=0.98), protein content(p=0.39), or glucose concentration (p=0.31). Of the CSF+ infants, 6 (60%) had SNHL, while 10 (83%) CSF- infants had SNHL. Abnormalities on CNS imaging studies, either ultrasound/CT/MRI, were comparable between groups. Conclusion: CMV was frequently detected in CSF of infants with clinically apparent congenital CMV infection. However, its detection was not associated with increased rate of SNHL or neuroimaging abnormalities. Larger studies that incorporate neurodevelopmental assessments are needed to determine the potential role of CSF evaluation in the management of infants with congenital CMV infection.
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
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    ABSTRACT: Background: Congenital CMV infection (cCMV) is a common congenital infection and a significant contributor to non-genetic sensorineural hearing loss (SNHL). Real-time PCR of newborn saliva specimens has been shown to be highly sensitive and specific compared to culture based methods for CMV screening. Although both saliva and urine samples are known to be acceptable for identifying infants with cCMV, it is thought that urine samples may contain more virus and thus, are optimal for cCMV screening. The objective is to compare viral load (VL) levels between saliva and urine samples from a large cohort of infants with cCMV infection identified through a newborn screening program. Methods: As part of the NIDCD CHIMES study, newborns at 7 U.S. medical centers were screened for CMV by saliva and dried blood spot PCR. Infants who screened positive were enrolled in a follow-up study to confirm congenital infection by testing saliva and urine samples using a previously described real-time PCR assay. CMV viral load in saliva samples obtained at screening and enrollment was compared to urine collected at enrollment in follow-up. Results: Of the 100,332 newborns screened for CMV from 2007 to 2011, viral load levels in both saliva and urine samples were available in 73% (336/462) of infants with confirmed cCMV. Of these, 36% (121/336) were enrolled within the first 3 weeks of life. The median viral load level in saliva at screening and enrollment (2.x106 IU/ml and 1.1x107 IU/ml, respectively) was significantly higher than in urine (8.3x105 IU/ml; p < 0.0001). There was no significant difference between VL in saliva and urine in infants with and without symptomatic disease and with and without congenital SNHL. In the smaller cohort of infants enrolled within 3 weeks of birth, median saliva VL at screening and enrollment (1.1x106 IU/ml vs. 9.3x106 IU/ml, respectively) was higher than urine VL (7.9x105IU/ml; p < 0.0001) . Conclusion: Infants with congenital CMV infection shed large amounts of virus in both saliva and urine. However, saliva samples contained higher viral load than urine, are easier to collect and do not require DNA extraction. Therefore, we propose that saliva should be considered the ideal specimen and real-time PCR of saliva is appropriate for both newborn screening and diagnosis of cCMV.
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
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    ABSTRACT: Background: Prolonged antibiotic therapy among preterm infants in the NICU is associated with adverse outcomes including death and necrotizing enterocolitis. The optimal metric to measure antibiotic use in the NICU and thus guide stewardship efforts is unknown. The purpose of this study was to apply two different metrics of antibiotic use to a large cohort of NICU infants and compare the results. Methods: Prospective collection and analysis of all antibiotics provided to every infant admitted to the NICU at Parkland Memorial Hospital, Dallas during a 14 month period (SCOUT study). Pertinent clinical and outcome data were collected. Two different metrics for determining antibiotic use were calculated for all antibiotics: 1) days of therapy (DOT) and 2) number of calendar days (CD) that the antibiotics were administered. DOT was calculated by dividing the dosing interval by 24 hours, then multiplying by the number of doses, summed for each antibiotic. CD was determined by the number of days in which a dose of an antibiotic was administered. For example, a 6-dose course of q8 hour ampicillin begun Monday evening and completed Wednesday morning would equal 2 DOT (8 ÷ 24 x 6 = 2) and 3 CD (Mon, Tue, Wed = 3). Results: 1521 infants were admitted during the study period; 364 (24%) received no systemic antibiotics and were excluded. 1157 infants (76%) accounted for 19,788 hospital days and received 1439 separate antibiotic courses. The total volume of antibiotic administered was 9394 by DOT and 5915 by CD. Agent-specific antibiotic use by DOT and CD is shown (Table). Antibiotic No. of courses DOT CD % difference All 1439 9394 5915 -37% Gentamicin 1399 4468 4551 2% Ampicillin 1233 3579 4417 31% Oxacillin 181 676 874 23% Vancomycin 41 249 276 11% Piperacillin/tazobactam 36 171 195 14% 1st generation cephalosporins 18 10 23 130% Penicillin 12 69 77 12% 3rd generation cephalosporins 6 10 13 30% Meropenem 5 26 30 14% Metronidazole 4 38 42 11% Other 14 98 115 17% Conclusion: Antibiotic use in the NICU varies substantially by the metric used. When used to describe a course of antibiotics, CD does not account for the number of agents. When used for specific agents, CD overestimates therapy volume by 13% on average. Our ongoing evaluation of which metric best predicts adverse outcomes is important to guide antibiotic stewardship efforts.
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
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    ABSTRACT: Background: Neonatal enterovirus (EV) infections have high morbidity & mortality. Antiviral therapy is not currently available. Pleconaril is an oral capsid binder with activity against EVs. Methods: Neonates with suspected EV sepsis (hepatitis, coagulopathy, or myocarditis) were randomized 2:1 to receive oral pleconaril or placebo x 7 days. Specimens (oropharynx, rectum, urine, serum) for viral culture & polymerase chain reaction (PCR), pharmacokinetic analysis, & safety evaluations were obtained over 14 days & clinical assessments were performed over 24 months. Results: 61 subjects were enrolled (43 treatment, 18 placebo), of whom 43 were confirmed EV-infected by culture or PCR (31 treatment, 12 placebo). Baseline characteristics were similar between EV-infected groups; median (range) age at illness onset was 4.5 (1-15) & 5.0 (1-10) days, respectively. Low culture yields precluded demonstrating a difference in the primary endpoint, day 5 oropharyngeal culture positivity (25% positive on Day 1 & 0% on Day 5 in the treatment group v. 30% on Day 1 & 0% on Day 5 in the placebo group). However, subjects in the treatment group became culture-negative from all anatomic sites combined faster than subjects in the placebo group (Fig 1; median 4.0 v. 7.0 days, p = 0.08) & fewer subjects in the treatment group remained PCR-positive from the oropharynx when last sampled (83% positive on Day 1 & 23% positive at a median of 14 days in the treatment group v. 100% positive on Day 1 & 58% positive at a median of 14 days in the placebo group, p = 0.02). By intent to treat, 10/43 (23%) of all subjects in the treatment group & 8/18 (44%) in the placebo group died (Fig 2; p = 0.02 for 2 month survival difference). Among EV-confirmed subjects, 7/31 (23%) in the treatment group died v. 5/12 (42%) in the placebo group (Fig 3; p = 0.26). Pleconaril concentrations exceeded the IC90 after the first treatment day, but 41% of subjects did not achieve this targetduring the 1st treatment day. 1 subject in the treatment group & 3 in the placebo group had treatment-related adverse events. Conclusion: Shorter times to culture & PCR negativity & suggestion of greater survival among pleconaril recipients support potential efficacy & warrant further evaluation. SEQ Figure * ARABIC 1. Culture positive SEQ Figure * ARABIC 2. Survival, all subjects SEQ Figure * ARABIC 3. Survival, EV-confirmed
    IDWeek 2014 Meeting of the Infectious Diseases Society of America; 10/2014
  • Joseph B Cantey, Phillip S Wozniak, Pablo J Sánchez
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    ABSTRACT: Background: Prolonged or unnecessary antibiotic use is associated with adverse outcomes in neonates. Our objectives were to quantify all antibiotic use in a Level III NICU and to identify scenarios where their use could be reduced. Methods: Surveillance and evaluation of all antibiotic use provided to every infant admitted to a Level III NICU from 10/3/11-11/30/12 was performed. Types of antibiotics, reasons for their initiation, discontinuation, and duration, as well as clinical, laboratory and outcome data were recorded. Antibiotic use was quantified by days of therapy (DOT) per 1000 patient-days (PD). Results: 1607 infants were included. The total antibiotic use was 9165 DOT (343.2 DOT/1000 PD; 5.7 DOT/infant). 72% of infants received 1 (43%) or more (29%) courses of antibiotics. Gentamicin (46%), ampicillin (39%), and oxacillin (8%) were the most frequently used agents. 94% of antibiotic use (323 DOT/1000 PD) was empiric therapy for suspected infection. 63% (216.2 DOT/1000 PD) was discontinued at approximately 48 hours when cultures were sterile (68% >48 h, 32% <=48 h). 26% of all antibiotic use (89.4 DOT/1000 PD) was therapy for >= 5 days despite sterile cultures; pneumonia (16%) and "culture-negative" sepsis (8%) were the major contributors. 5% (17.4 DOT/1000 PD) of antibiotic use was for culture-proven sepsis, 5% (16.6 DOT/1000 PD) was penicillin prophylaxis for group B Streptococcus, and 1% (3.5 DOT/1000 PD) was pre-procedural prophylaxis. Conclusions: Narrow-spectrum therapy accounted for >92% of antibiotic use and would not be monitored by most stewardship programs. Only 5% of antibiotic usage was due to culture-proven infection. Pneumonia and "culture-negative" sepsis were frequent reasons for prolonged therapy; further study of these conditions may allow reduction in treatment duration.
    The Pediatric Infectious Disease Journal 09/2014; 34(3). DOI:10.1097/INF.0000000000000542 · 3.14 Impact Factor
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    ABSTRACT: Objective Obstetric antecedents were analyzed in births where the infant received whole-body cooling for neonatal encephalopathy. Methods This retrospective cohort study included all live-born singleton infants delivered at or beyond 36 weeks gestation from October 2005 through December 2011. Infants who had received whole-body cooling identified by review of a prospective neonatal registry were compared to a control group comprising the remaining obstetric population delivered at greater than 36 weeks but not cooled. Univariable analysis was followed by a staged, stepwise selection of variables with the intent to rank significant risk factors for cooling. Results A total of 86,371 women delivered during the study period and 98 infants received whole-body cooling (1.1/1,000 livebirths). Of these 98 infants, 80 (88%) newborns had moderate encephalopathy and 10 (12%) had severe encephalopathy prior to cooling. Maternal age less than or equal to 15 years, low parity, maternal body habitus (BMI > 40 kg/m2), diabetes, preeclampsia, induction, epidural analgesia, chorioamnionitis, length of labor, and mode of delivery were associated with significantly increased risk of infant cooling during univariable analysis. Catastrophic events to include umbilical cord prolapse (OR 14; 95%CI, 3-72), placental abruption (OR 17; 95%CI, 7-44), uterine rupture (OR 130; 95%CI, 11-1477) were the strongest factors associated with infant cooling after staged-stepwise logistic analysis. Conclusion A variety of intrapartum characteristics were associated with infant cooling for neonatal encephalopathy with the most powerful antecedents being umbilical cord prolapse, placental abruption, and uterine rupture.
    American journal of obstetrics and gynecology 08/2014; 211(2). DOI:10.1016/j.ajog.2014.02.013 · 3.97 Impact Factor
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    ABSTRACT: Objective: Antenatal magnesium (anteMg) is used for various obstetric indications including fetal neuroprotection. Infants exposed to anteMg may be at risk for respiratory depression and delivery room (DR) resuscitation. The study objective was to compare the risk of acute cardio-respiratory (CR) events among preterm infants who were and were not exposed (noMg) to anteMg. Study Design: This was a retrospective analysis of prospective data collected in the NICHD Neonatal Research Network's Generic Database from 4/1/11 to 3/31/12. The primary outcome was DR intubation or respiratory support at birth or on day 1 of life. Secondary outcomes were invasive mechanical ventilation (MV), hypotension treatment, neonatal morbidities and mortality. Logistic regression analysis evaluated the risk of primary outcome after adjustment for covariates. Results: We evaluated 1,544 infants <29 weeks GA (1,091 in anteMg group and 453 in noMg group). Mothers in the anteMg group were more likely to have higher education, pregnancy-induced hypertension and antenatal corticosteroids; while their infants were younger in gestation and weighed less (P<0.05). The primary outcome (odds ratio [OR], 1.2, 95% confidence interval [CI], 0.88-1.65) was similar between groups. Hypotension treatment (OR, 0.70, 95% CI, 0.51-0.97) and invasive MV (OR, 0.54, 95% CI, 0.41-0.72) were significantly less in the anteMg group. Conclusion: Among preterm infants <29 weeks gestation, anteMg exposure was not associated with an increase in CR events in the early newborn period. The safety of anteMg as measured by the need for DR intubation or respiratory support on day 1 of life was comparable between groups.
    American Journal of Obstetrics and Gynecology 07/2014; 212(1). DOI:10.1016/j.ajog.2014.07.023 · 3.97 Impact Factor
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    ABSTRACT: Objective To determine the frequency of respiratory viral infections among infants who were evaluated for late-onset sepsis in the neonatal intensive care units (NICUs) of Parkland Memorial Hospital, Dallas, Texas; and Women & Infants Hospital, Providence, Rhode Island. Study design Prospective cohort study conducted from January 15, 2012 to January 31, 2013. Infants in the NICU were enrolled if they were inborn, had never been discharged home, and were evaluated for sepsis (at >72 hours of age) and antibiotic therapy was initiated. Infants had a nasopharyngeal specimen collected for detection of respiratory viruses by multiplex polymerase chain reaction within 72 hours of the initiation of antibiotic therapy. Their medical records were reviewed for demographic, clinical, radiographic, and laboratory data until NICU discharge. Results During the 13-month study, 8 of 100 infants, or 8 (6%) of the 135 sepsis evaluations, had a respiratory virus detected by polymerase chain reaction (2, enterovirus/rhinovirus; 2, rhinovirus; 2, coronaviruses; and 2, parainfluenza-3 virus). By bivariate analysis, the infants with viral detection were older (41 vs 11 days; P = .007), exposed to individuals with respiratory tract viral symptoms (37% vs 2%; P = .003), tested for respiratory viruses by provider (75% vs 11%; P < .001), and had lower total neutrophil counts (P = .02). In multivariate regression analysis, the best predictor of viral infection was the caregivers' clinical suspicion of viral infection (P = .006). Conclusions A total of 8% of infants, or 6% of all NICU sepsis evaluations, had a respiratory virus detected when evaluated for bacterial sepsis. These findings argue for more respiratory viral testing of infants with suspected sepsis using optimal molecular assays to establish accurate diagnoses, prevent transmission, and inform antibiotic stewardship efforts.
    Journal of Pediatrics 07/2014; 165(4). DOI:10.1016/j.jpeds.2014.05.054 · 3.74 Impact Factor
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    ABSTRACT: IMPORTANCE Reduced death and neurodevelopmental impairment among infants is a goal of perinatal medicine. OBJECTIVE To assess the association between surgery during the initial hospitalization and death or neurodevelopmental impairment of very low-birth-weight infants. DESIGN, SETTING, AND PARTICIPANTS A retrospective cohort analysis was conducted of patients enrolled in the National Institute of Child Health and Human Development Neonatal Research Network Generic Database from 1998 through 2009 and evaluated at 18 to 22 months' corrected age. Twenty-two academic neonatal intensive care units participated. Inclusion criteria were birth weight 401 to 1500 g, survival to 12 hours, and availability for follow-up. A total of 12 111 infants were included in analyses. EXPOSURES Surgical procedures; surgery also was classified by expected anesthesia type as major (general anesthesia) or minor (nongeneral anesthesia). MAIN OUTCOMES AND MEASURES Multivariable logistic regression analyses planned a priori were performed for the primary outcome of death or neurodevelopmental impairment and for the secondary outcome of neurodevelopmental impairment among survivors. Multivariable linear regression analyses were performed as planned for the adjusted mean scores of the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development, Second Edition, for patients born before 2006. RESULTS A total of 2186 infants underwent major surgery, 784 had minor surgery, and 9141 infants did not undergo surgery. The risk-adjusted odds ratio of death or neurodevelopmental impairment for all surgery patients compared with those who had no surgery was 1.29 (95% CI, 1.08-1.55). For patients who had major surgery compared with those who had no surgery, the risk-adjusted odds ratio of death or neurodevelopmental impairment was 1.52 (95% CI, 1.24-1.87). Patients classified as having minor surgery had no increased adjusted risk. Among survivors who had major surgery compared with those who had no surgery, the adjusted risk of neurodevelopmental impairment was greater and the adjusted mean Bayley scores were lower. CONCLUSIONS AND RELEVANCE Major surgery in very low-birth-weight infants is independently associated with a greater than 50% increased risk of death or neurodevelopmental impairment and of neurodevelopmental impairment at 18 to 22 months' corrected age. The role of general anesthesia is implicated but remains unproven.
    JAMA Pediatrics 06/2014; 168(8). DOI:10.1001/jamapediatrics.2014.307 · 4.25 Impact Factor
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    ABSTRACT: Objective:The use of inhaled nitric oxide (iNO) in preterm infants remains controversial. In October 2010, a National Institutes of Health consensus development conference cautioned against use of iNO in preterm infants. This study aims (1) to determine the prevalence and variability in use of iNO in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NICHD NRN) before and after the consensus conference and (2) separately, to examine associations between iNO use and severe bronchopulmonary dysplasia (BPD) or death.Study design:The NICHD NRN Generic Database collects data including iNO use on very preterm infants. A total of 13 centers contributed data across the time period 2008 to 2011. Infants exposed or not to iNO were compared using logistic regression, which included factors related to risk as well as their likelihood of being exposed to iNO.Result:A total of 4885 infants were assessed between 2008 and 2011; 128 (2.6%) received iNO before day 7, 140 (2.9%) between day 7 and 28, and 47 (1.0%) at >28 days. Center-specific iNO use during 2008 to 2010 ranged from 21.9 to 0.4%; 12 of 13 sites reduced usage and overall NRN iNO usage decreased from 4.6 to 1.6% (P<0.001) in 2011. The use of iNO started between day 7 and day 14 was more prevalent among younger infants with more severe courses in week 1 and associated with increased risk of severe BPD or death (odds ratio 2.24; 95% confidence interval 1.23 to 4.07).Conclusion:The variability and total use of iNO decreased in 2011 compared with 2008 to 2010. iNO administration started at ⩾day 7 was associated with more severe outcomes compared with infants without iNO exposure.Journal of Perinatology advance online publication, 5 June 2014; doi:10.1038/jp.2014.105.
    Journal of perinatology: official journal of the California Perinatal Association 06/2014; 34(11). DOI:10.1038/jp.2014.105 · 2.35 Impact Factor
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    ABSTRACT: Objective To test the hypothesis that the proportion of endotracheal intubation (ETI) in the delivery room (DR) decreased in Neonatal Research Network (NRN) centres after the National Institute of Child Health and Human Development NRN Surfactant, Positive Pressure, and Oxygenation Randomised Trial (SUPPORT). Design Retrospective cohort study using the prospective NRN generic database. Setting Eleven centres that participated in the SUPPORT trial and remained part of the NRN. Preterm neonates 24(0/7)-27(6/7) weeks' gestational age enrolled in the SUPPORT trial were randomised to: (1) DR continuous positive airway pressure or DR ETI with early surfactant administration; and (2) oxygen saturation targets of 85-89% or 91-95%. The prior NRN feasibility trial had assessed the feasibility of randomisation to continuous positive airway pressure versus ETI. Patients Infants 24(0/7)-27(6/7) weeks' gestational age, excluding infants with syndromes or major malformations and those on comfort care only. Main outcome measure Proportion of DR ETI. Results The proportion of DR ETI decreased significantly in the group of infants from centres that had not participated in the feasibility trial (91% before vs 75% after SUPPORT, adjusted relative risk 0.86, 95% CI 0.83-0.89, p<0.0001) but not in the group of infants from the other centres, where the proportion of ETI was already lower prior to initiation of the SUPPORT trial (61% before vs 58% after SUPPORT, adjusted relative risk 0.96, 95% CI 0.89 to 1.05, p=0.40). Conclusion This study shows that DR ETI changed after SUPPORT only in NRN centres that had not participated in a similar trial.
    Archives of Disease in Childhood - Fetal and Neonatal Edition 05/2014; 99(5). DOI:10.1136/archdischild-2014-306057 · 3.86 Impact Factor

Publication Stats

4k Citations
903.53 Total Impact Points

Institutions

  • 2014–2015
    • Nationwide Children's Hospital
      • Center for Perinatal Research
      Columbus, Ohio, United States
    • The Ohio State University
      • Department of Pediatrics
      Columbus, Ohio, United States
    • Brown University
      • Department of Pediatrics
      Providence, Rhode Island, United States
  • 1990–2015
    • University of Texas Southwestern Medical Center
      • • Department of Pediatrics
      • • Department of Internal Medicine
      • • Department of Obstetrics and Gynecology
      Dallas, Texas, United States
  • 1989–2014
    • University of Texas at Dallas
      Richardson, Texas, United States
  • 2013
    • University of Rochester
      • School of Medicine and Dentistry
      Rochester, NY, United States
  • 2008–2012
    • University of Alabama at Birmingham
      • Department of Pediatrics
      Birmingham, AL, United States
    • National Cancer Institute (USA)
      베서스다, Maryland, United States
  • 2011
    • Children's Medical Center Dallas
      Dallas, Texas, United States
  • 2010
    • King Abdulaziz Medical City in Jeddah
      Djidda, Makkah, Saudi Arabia
  • 2003
    • University of Colorado Hospital
      • Department of Pediatrics
      Denver, Colorado, United States