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ABSTRACT: AIM: Preterm infants begin the transition from gastric tube feeds to sucking feeds around 34 weeks' postmenstrual age. We compared physiological stability in two bottle feeding positions, cradle hold versus side lying in preterm infants. METHODS: Randomised crossover trial of infants <34 weeks' gestation at birth, ≥34 weeks' postmenstrual age at study and receiving at least two sucking feeds/day. Two feeds were studied on successive days. A pulse oximeter measured oxygen saturation (SpO2 ) and heart rate (HR) before, during and 30 min after feeds. Continuous data were compared using paired t-tests and proportions using chi squared. RESULTS: Twenty-five study infants were mean (standard deviation (SD)) 37 (2.4) weeks' post-menstrual age and 2740 (589) g at study. There was little difference in mean (SD) SpO2 during feeds between the cradle-hold and side-lying position 94 (6) % versus 95 (6) %, respectively (P = 0.55, confidence interval (CI) -1.4, 5.4). During feeds, 17/25 (68%) experienced a period of SpO2 <80% in the cradle-hold position compared with 14/25 (56) % in the side-lying position (P = 0.26, CI 0.68, 4.10). There were no significant differences in the mean HR or number of episodes of bradycardia HR <100 bpm. There was a trend towards infants consuming a smaller mean (SD) proportion of their feed in the cradle-hold position compared with the side-lying position, 82 (25) % versus 87 (20) % (P = 0.08, CI -0.64, 10.00). CONCLUSIONS: There was little difference in infants' physiological stability between the two bottle feeding positions. Both methods may be appropriate for the transition from gastric tube to sucking feeds in preterm infants.
Journal of Paediatrics and Child Health 04/2013; · 1.28 Impact Factor
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ABSTRACT: The "synactive" theory of neurobehavioral development forms the basis of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Our objective was to assess the effectiveness of NIDCAP in improving outcomes in preterm infants.
Medline, CINAHL, Embase, PsychInfo, The Cochrane Library, Pediatric Academic Societies' Abstracts and Web of Science were searched in July 2010 and February 2012. The studies selected were randomized controlled trials testing the effectiveness of NIDCAP on medical and neurodevelopmental outcomes. The authors abstracted baseline characteristics of infants and outcomes. The risk of bias was assessed by using Cochrane criteria. RevMan 5.1 was used to synthesize data by the use of relative risk and risk difference for dichotomous outcomes and mean or standardized mean difference for continuous outcomes.
Eleven primary and 7 secondary studies enrolling 627 neonates were included, with 2 of high quality. The composite primary outcomes of death or major sensorineural disability at 18 months corrected age or later in childhood (3 trials, 302 children; relative risk 0.89 [95% confidence interval 0.61 to 1.29]) and survival free of disability at 18 months corrected age or later in childhood (2 trials, 192 infants; relative risk 0.97 [95% confidence interval 0.69 to 1.35]), were not significantly different between the NIDCAP and control groups. With the sensitivity analysis that excluded the 2 statistically heterogeneous outlying studies, there were no significant differences between groups for short-term medical outcomes.
This systematic review including 627 preterm infants did not find any evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcomes.
PEDIATRICS 03/2013; 131(3):e881-93. · 4.47 Impact Factor
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ABSTRACT: Newborn animal studies and pilot studies in humans suggest that mild hypothermia following peripartum hypoxia-ischaemia in newborn infants may reduce neurological sequelae without adverse effects.
To determine the effect of therapeutic hypothermia in encephalopathic asphyxiated newborn infants on mortality, long-term neurodevelopmental disability and clinically important side effects.
We used the standard search strategy of the Cochrane Neonatal Review Group as outlined in The Cochrane Library (Issue 2, 2007). Randomised controlled trials evaluating therapeutic hypothermia in term and late preterm newborns with hypoxic ischaemic encephalopathy were identified by searching the Oxford Database of Perinatal Trials, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2007, Issue 2), MEDLINE (1966 to June 2007), previous reviews including cross-references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching. We updated this search in May 2012.
We included randomised controlled trials comparing the use of therapeutic hypothermia with standard care in encephalopathic term or late preterm infants with evidence of peripartum asphyxia and without recognisable major congenital anomalies. The primary outcome measure was death or long-term major neurodevelopmental disability. Other outcomes included adverse effects of cooling and 'early' indicators of neurodevelopmental outcome.
Four review authors independently selected, assessed the quality of and extracted data from the included studies. Study authors were contacted for further information. Meta-analyses were performed using risk ratios (RR) and risk differences (RD) for dichotomous data, and weighted mean difference for continuous data with 95% confidence intervals (CI).
We included 11 randomised controlled trials in this updated review, comprising 1505 term and late preterm infants with moderate/severe encephalopathy and evidence of intrapartum asphyxia. Therapeutic hypothermia resulted in a statistically significant and clinically important reduction in the combined outcome of mortality or major neurodevelopmental disability to 18 months of age (typical RR 0.75 (95% CI 0.68 to 0.83); typical RD -0.15, 95% CI -0.20 to -0.10); number needed to treat for an additional beneficial outcome (NNTB) 7 (95% CI 5 to 10) (8 studies, 1344 infants). Cooling also resulted in statistically significant reductions in mortality (typical RR 0.75 (95% CI 0.64 to 0.88), typical RD -0.09 (95% CI -0.13 to -0.04); NNTB 11 (95% CI 8 to 25) (11 studies, 1468 infants) and in neurodevelopmental disability in survivors (typical RR 0.77 (95% CI 0.63 to 0.94), typical RD -0.13 (95% CI -0.19 to -0.07); NNTB 8 (95% CI 5 to 14) (8 studies, 917 infants). Some adverse effects of hypothermia included an increase sinus bradycardia and a significant increase in thrombocytopenia.
There is evidence from the 11 randomised controlled trials included in this systematic review (N = 1505 infants) that therapeutic hypothermia is beneficial in term and late preterm newborns with hypoxic ischaemic encephalopathy. Cooling reduces mortality without increasing major disability in survivors. The benefits of cooling on survival and neurodevelopment outweigh the short-term adverse effects. Hypothermia should be instituted in term and late preterm infants with moderate-to-severe hypoxic ischaemic encephalopathy if identified before six hours of age. Further trials to determine the appropriate techniques of cooling, including refinement of patient selection, duration of cooling and method of providing therapeutic hypothermia, will refine our understanding of this intervention.
Cochrane database of systematic reviews (Online) 01/2013; 1:CD003311. · 5.72 Impact Factor
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ABSTRACT: Probiotics are micro-organisms that confer health benefits on the host. Postulated mechanisms include: increasing resistance of the mucosal barrier to migration of bacteria and their toxins by strengthening intestinal cell junctions, modification of host response to microbial products, augmentation of immunoglobulin A mucosal responses, enhancement of enteral nutrition to inhibit the growth of pathogens; production of antimicrobial proteins; and competitive exclusion of potential pathogens. Published meta-analyses and systematic reviews report the effects of probiotics on important clinical outcomes in neonates. This paper will review the evidence for probiotic supplementation in neonatology, with a focus on preterm infants.
Journal of Paediatrics and Child Health 08/2012; 48(9):777-783. · 1.28 Impact Factor
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ABSTRACT: To investigate the effects of hypothermia treatment on magnetic resonance imaging (MRI) patterns of brain injury in newborns with hypoxic-ischemic encephalopathy compared with normothermia, including the prognostic utility of MRI for death and/or disability at a postnatal age of 2 years.
Substudy of a randomized controlled trial.
Participating centers in the Infant Cooling Evaluation trial.
Trial participants (gestational age ≥35 weeks with moderate to severe hypoxic-ischemic encephalopathy, randomized to whole-body hypothermia or normothermia) with available MRIs.
We performed qualitative evaluation of T1- and T2-weighted and diffusion MRIs. The posterior limb of the internal capsule was classified as normal or abnormal, whereas the basal ganglia and thalami, white matter, and cortical gray matter were classified as normal or mildly abnormal or moderately/severely abnormal.
Death or major disability at 2 years.
We evaluated 127 MRIs (66 patients treated with hypothermia and 61 with normothermia; mean age at scan, 6 postnatal days). The odds of having moderate/severe white matter or cortical gray matter abnormalities on T1- and T2-weighted MRI were reduced by hypothermia (white matter odds ratio, 0.28 [95% CI, 0.09-0.82]; gray matter odds ratio, 0.41 [0.17-1.00]). Abnormal MRI findings predicted adverse outcomes, with T1- and T2-weighted and diffusion MRI abnormalities in the posterior limb of the internal capsule and basal ganglia and thalami demonstrating the greatest predictive value. There was little evidence that prognostic value of the MRI was modified by therapeutic hypothermia (all interactions, P > .05).
Brain injury on T1- and T2-weighted MRI is reduced in hypothermia-treated newborns. Abnormal MRI findings are prognostic of long-term outcome in moderate to severe hypoxic-ischemic encephalopathy regardless of treatment with hypothermia.
Archives of pediatrics & adolescent medicine 07/2012; 166(7):634-40. · 3.73 Impact Factor
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ABSTRACT: OBJECTIVE: To determine the accuracy of axillary temperature relative to core rectal temperature during whole-body therapeutic hypothermia for moderate-to-severe hypoxic-ischaemic encephalopathy. DESIGN: Retrospective audit. SETTING: Single tertiary neonatal intensive care unit at The Royal Women's Hospital in Australia. PATIENTS: Fifty-eight term newborn infants with moderate-to-severe hypoxic-ischaemic encephalopathy. Forty infants were treated with whole-body hypothermia between February 2001 and May 2010, 16 of whom were enrolled in the Infant Cooling Evaluation (ICE) trial, and 18 control infants randomised to normothermia in the ICE trial. INTERVENTION: Comparison of simultaneous axillary and rectal temperatures measured between 0 and 84 h post randomisation or induction of cooling. RESULTS: During the initiation of hypothermia (0-<6 h) axillary and rectal temperatures were similar (mean difference rectal-axillary =0.07°C), but with large variability (95% limits of agreement -1.18 to 1.33°C). There was larger variability in measurements between 6 and <72 h in the hypothermic infants (total SD 0.44) than in the normothermic group (total SD 0.24, p<0.001). In the hypothermic infants, the mean difference between the measurements during the rewarming phase (72-<84 h) was -0.19°C (95% limits of agreement -0.95 to 0.57°C). CONCLUSION: As there is wide variability in the difference between axillary and rectal temperatures at all stages of whole-body cooling, our data do not support the use of axillary temperature as a surrogate for core rectal temperature during therapeutic hypothermia.
Archives of Disease in Childhood - Fetal and Neonatal Edition 05/2012; · 3.05 Impact Factor
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Rosemary D Higgins,
Tonse Raju,
A David Edwards,
Denis V Azzopardi,
Carl L Bose,
Reese H Clark,
Donna M Ferriero,
Ronnie Guillet,
Alistair J Gunn,
Henrik Hagberg, [......],
Charles Palmer,
Luann Papile,
Robert H Pfister,
Nicola J Robertson,
Mary Rutherford,
Seetha Shankaran,
Faye S Silverstein,
Roger F Soll,
Marianne Thoresen,
William F Walsh
The Journal of pediatrics 08/2011; 159(5):851-858.e1. · 4.02 Impact Factor
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Suzanne M Garland,
Jacinta M Tobin,
Marie Pirotta,
Sepehr N Tabrizi,
Gillian Opie,
Susan Donath,
Mimi L K Tang,
Colin J Morley,
Leah Hickey,
Linh Ung, Susan E Jacobs
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ABSTRACT: Late onset sepsis is a frequent complication of prematurity associated with increased mortality and morbidity. The commensal bacteria of the gastrointestinal tract play a key role in the development of healthy immune responses. Healthy term infants acquire these commensal organisms rapidly after birth. However, colonisation in preterm infants is adversely affected by delivery mode, antibiotic treatment and the intensive care environment. Altered microbiota composition may lead to increased colonisation with pathogenic bacteria, poor immune development and susceptibility to sepsis in the preterm infant.Probiotics are live microorganisms, which when administered in adequate amounts confer health benefits on the host. Amongst numerous bacteriocidal and nutritional roles, they may also favourably modulate host immune responses in local and remote tissues. Meta-analyses of probiotic supplementation in preterm infants report a reduction in mortality and necrotising enterocolitis. Studies with sepsis as an outcome have reported mixed results to date.Allergic diseases are increasing in incidence in "westernised" countries. There is evidence that probiotics may reduce the incidence of these diseases by altering the intestinal microbiota to influence immune function.
This is a multi-centre, randomised, double blinded, placebo controlled trial investigating supplementing preterm infants born at < 32 weeks' gestation weighing < 1500 g, with a probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus and Bifidobacterium lactis). A total of 1,100 subjects are being recruited in Australia and New Zealand. Infants commence the allocated intervention from soon after the start of feeds until discharge home or term corrected age. The primary outcome is the incidence of at least one episode of definite (blood culture positive) late onset sepsis before 40 weeks corrected age or discharge home. Secondary outcomes include: Necrotising enterocolitis, mortality, antibiotic usage, time to establish full enteral feeds, duration of hospital stay, growth measurements at 6 and 12 months' corrected age and evidence of atopic conditions at 12 months' corrected age.
Results from previous studies on the use of probiotics to prevent diseases in preterm infants are promising. However, a large clinical trial is required to address outstanding issues regarding safety and efficacy in this vulnerable population. This study will address these important issues.
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN012607000144415The product "ABC Dophilus Probiotic Powder for Infants®", Solgar, USA has its 3 probiotics strains registered with the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ--German Collection of Microorganisms and Cell Cultures) as BB-12 15954, B-02 96579, Th-4 15957.
BMC Infectious Diseases 08/2011; 11:210. · 3.12 Impact Factor
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ABSTRACT: To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.
Multicenter, international, randomized controlled trial.
Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007.
Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n = 110) or standard care (n = 111).
Whole-body hypothermia to 33.5°C for 72 hours or standard care (37°C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33°C to 34°C.
Death or major sensorineural disability at 2 years of age.
Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P = .03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.
Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.
anzctr.org.au Identifier: ACTRN12606000036516.
Archives of pediatrics & adolescent medicine 04/2011; 165(8):692-700. · 3.73 Impact Factor
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ABSTRACT: Peripartum asphyxia complicated by moderate or severe hypoxic-ischaemic encephalopathy is a devastating global health issue. A therapeutic 'window of opportunity' exists after resuscitation of the asphyxiated newborn and before the delayed phase of neuronal loss. Animal studies demonstrated that neuronal injury following hypoxia-ischaemia can be prevented or reduced by a mild reduction in brain temperature. Human infant pilot studies confirmed feasibility, without major adverse effects. Randomised trials and systematic reviews comprising term infants with moderate or severe encephalopathy and peripartum asphyxia have established the neuroprotective benefit of therapeutic hypothermia. Hypothermia reduces mortality or major disability to 18 months of age, as well as cerebral palsy, and neuromotor and cognitive delay. Importantly, mortality is reduced without any increase in major neurodevelopmental disability in survivors, and with only minor adverse effects. The evidence supports therapeutic hypothermia when used within strict protocols in tertiary centres to improve the outcome for term and near-term newborns with moderate or severe hypoxic-ischaemic encephalopathy. Equally strict protocols in non-tertiary nurseries will enable earlier initiation of hypothermia under guidance of the regional neonatal intensive care unit and transport team.
Journal of Paediatrics and Child Health 10/2010; 46(10):568-76. · 1.28 Impact Factor
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PEDIATRICS 09/2010; 126(3):e741-2; author reply e743-5. · 4.47 Impact Factor
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ABSTRACT: Background
Newborn animal studies and pilot studies in humans suggest that mild hypothermia following peripartum hypoxia-ischaemia in newborn infants may reduce neurological sequelae without adverse effects.Objectives
To determine the effect of therapeutic hypothermia in encephalopathic asphyxiated newborn infants on mortality, long-term neurodevelopmental disability and clinically important side effects.Search strategyThe standard search strategy of the Neonatal Review Group as outlined in The Cochrane Library (Issue 2, 2007) was used. Randomised controlled trials evaluating therapeutic hypothermia in term newborns with hypoxic ischaemic encephalopathy were identified by searching the Oxford Database of Perinatal Trials, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2007), MEDLINE (1966 to June 2007), previous reviews including cross-references, abstracts, conferences, symposia proceedings, expert informants and journal hand searching.Selection criteriaRandomised controlled trials comparing the use of therapeutic hypothermia with standard care in encephalopathic newborn infants with evidence of peripartum asphyxia and without recognisable major congenital anomalies were included. The primary outcome measure was death or long-term major neurodevelopmental disability. Other outcomes included adverse effects of cooling and 'early' indicators of neurodevelopmental outcome.Data collection and analysisThree review authors independently selected, assessed the quality of and extracted data from the included studies. Authors were contacted for further information. Meta-analyses were performed using relative risk and risk difference for dichotomous data, and weighted mean difference for continuous data with 95% confidence intervals.Main resultsEight randomised controlled trials were included in this review, comprising 638 term infants with moderate/ severe encephalopathy and evidence of intrapartum asphyxia. Therapeutic hypothermia resulted in a statistically significant and clinically important reduction in the combined outcome of mortality or major neurodevelopmental disability to 18 months of age [typical RR 0.76 (95% CI 0.65, 0.89), typical RD -0.15 (95% CI -0.24, -0.07), NNT 7 (95% CI 4, 14)]. Cooling also resulted in statistically significant reductions in mortality [typical RR 0.74 (95% CI 0.58, 0.94), typical RD -0.09 (95% CI -0.16, -0.02), NNT 11 (95% CI 6, 50)] and in neurodevelopmental disability in survivors [typical RR 0.68 (95% CI 0.51, 0.92), typical RD -0.13 (95% CI -0.23, -0.03)]. Some adverse effects of hypothermia included an increase in the need for inotrope support of borderline significance and a significant increase in thrombocytopaenia.Authors' conclusionsThere is evidence from the eight randomised controlled trials included in this systematic review (n = 638) that therapeutic hypothermia is beneficial to term newborns with hypoxic ischaemic encephalopathy. Cooling reduces mortality without increasing major disability in survivors. The benefits of cooling on survival and neurodevelopment outweigh the short-term adverse effects. However, this review comprises an analysis based on less than half of all infants currently known to be randomised into eligible trials of cooling. Incorporation of data from ongoing and completed randomised trials (n = 829) will be important to clarify the effectiveness of cooling and to provide more information on the safety of therapeutic hypothermia, but could also alter these conclusions. Further trials to determine the appropriate method of providing therapeutic hypothermia, including comparison of whole body with selective head cooling with mild systemic hypothermia, are required.Plain language summaryCooling for newborns with hypoxic ischaemic encephalopathyThere is evidence that induced hypothermia (cooling) of newborn babies who may have suffered from a lack of oxygen at birth reduces death or disability, without increasing disability in survivors. This means that parents should expect that cooling will decrease their baby's chance of dying, and that if their baby survives, cooling will decrease his/her chance of major disability. A lack of oxygen before and during birth can destroy cells in a newborn baby's brain. The damage caused by the lack of oxygen continues for some time afterwards. One way to try and stop this damage is to induce hypothermia - cooling the baby or just the baby's head for hours to days. This treatment may reduce the amount of damage to brain cells. This review found that there is evidence from trials to show that induced hypothermia helps to improve survival and development at 18 months for term newborn babies at risk of brain damage. The results of ongoing trials may or may not confirm these favourable results. More research is also needed on the different methods of cooling.
Evidence-Based Child Health A Cochrane Review Journal 11/2008; 3(4):1049 - 1115.
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Rosemary D Higgins,
Tonse N K Raju,
Jeffrey Perlman,
Denis Victor Azzopardi,
Lillian R Blackmon,
Reese H Clark,
A David Edwards,
Donna M Ferriero,
Peter D Gluckman,
Alistair J Gunn, [......],
Dorothea Jenkins Eicher,
Alan H Jobe,
Abbot R Laptook,
Michael H LeBlanc,
Charles Palmer,
Seetha Shankaran,
Roger F Soll,
Ann R Stark,
Marianne Thoresen,
John Wyatt
Journal of Pediatrics 03/2006; 148(2):170-175. · 4.11 Impact Factor
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Susan E Jacobs
Journal of Pediatrics 08/2005; 147(1):122-3. · 4.11 Impact Factor
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ABSTRACT: Twenty-six infants with hypoxic-ischemic encephalopathy (HIE) were randomized to normothermia or to systemic hypothermia. The hypothermia group had less cortical gray matter signal abnormality on magnetic resonance imaging (MRI) (1/12 vs 7/14 infants in the normothermic group; P = .036), which may indicate differing regional benefit from systemic hypothermia.
Journal of Pediatrics 01/2005; 145(6):835-7. · 4.11 Impact Factor
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ABSTRACT: To systematically review the effectiveness of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) as compared with conventional care to improve long-term neurodevelopmental outcomes or short-term medical and neurodevelopmental outcomes in preterm and/or low birth weight infants.
With the use of standard systematic review methodology, all randomized, controlled trials (RCTs) and prospective cohort studies evaluating in-hospital developmental care based on the framework of NIDCAP in preterm and/or low birth weight infants were identified. The quality of the RCTs was assessed. Meta-analyses were performed by using relative risk and risk difference for dichotomous data and weighted mean difference for continuous data with 95% confidence intervals.
Five RCTs (n = 136) and 3 phase-lag cohort studies (n = 185) met inclusion criteria. School-age neurodevelopmental outcomes after NIDCAP have not been reported. Meta-analyses of medical outcomes showed a statistically significant benefit of NIDCAP on requirement for supplemental oxygen. Neurodevelopmental outcome was improved at 9 or 12 months but not at 2 years.
There is insufficient evidence to support the NIDCAP to improve medical and neurodevelopmental outcomes of preterm infants.
Journal of Pediatrics 07/2002; 140(6):699-706. · 4.11 Impact Factor
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Lakartidningen 104(3):134-7.
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