Trial reportPediatrics2008
Outcomes of safety and effectiveness in a multicenter randomized, controlled trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy.
Trial report in Pediatrics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 79 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Controlled Trial of Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants
Follow-up Visit of High Risk Infants
Who cites it
79 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- MRI scoring systems in neonatal encephalopathy and neurodevelopmental outcomes: a systematic review.Journal of perinatology : official journal of the California Perinatal Association · 2026Pooled it
- Neonatal encephalopathy: a systematic review of reported treatment outcomes.BMJ paediatrics open · 2024Pooled it
- Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis.Journal of global health · 2022Pooled it
- Hypothermia for neuroprotection in children after cardiopulmonary arrest.The Cochrane database of systematic reviews · 2013Pooled it
- Cooling for newborns with hypoxic ischaemic encephalopathy.The Cochrane database of systematic reviews · 2013Pooled it
- Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data.BMJ (Clinical research ed.) · 2010Pooled it
- Early Prediction of Outcome Using Lactate Dehydrogenase and Amplitude-Integrated EEG in Transported Newborn Infants with Hypoxic-Ischaemic Encephalopathy.Acta paediatrica (Oslo, Norway : 1992) · 2026Trial
- Trial
- Pulmonary Hypertension Associated with Hypoxic-Ischemic Encephalopathy-Antecedent Characteristics and Comorbidities.The Journal of pediatrics · 2018Trial
- Effect of inborn vs. outborn delivery on neurodevelopmental outcomes in infants with hypoxic-ischemic encephalopathy: secondary analyses of the NICHD whole-body cooling trial.Pediatric research · 2012Trial
- Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI).BMC pediatrics · 2012Trial
- Determinants of effective cooling during endovascular hypothermia.Neurocritical care · 2012Trial
- Temperature profile and outcomes of neonates undergoing whole body hypothermia for neonatal hypoxic-ischemic encephalopathy.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2012Trial
- Trial
- Article
- Whole-body vs. selective head cooling and target temperature strategies for neonatal HIE: a meta-analysis of long-term outcomes.Frontiers in pediatrics · 2026Review
- Motor Performance, Health-Related Quality of Life and Self-Esteem in Early Adolescence After Neonatal Therapeutic Hypothermia.Acta paediatrica (Oslo, Norway : 1992) · 2025Article
- Translational Potential of Stem Cell-based Therapies in the Treatment of Neonatal Hypoxic-ischemic Brain Injury.Stem cell reviews and reports · 2025Review
- Changes in the treatment and outcomes of different severities of neonatal hypoxic ischemic encephalopathy in California: a retrospective cohort study.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Impact of persistent pulmonary hypertension on cerebral oxygenation in infants with neonatal encephalopathy.Pediatric research · 2025Article
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundWhole-body hypothermia reduced the frequency of death or moderate/severe disabilities in neonates with hypoxic-ischemic encephalopathy in a randomized, controlled multicenter trial.
objectiveOur goal was to evaluate outcomes of safety and effectiveness of hypothermia in infants up to 18 to 22 months of age. DESIGN/
methodsA priori outcomes were evaluated between hypothermia (n = 102) and control (n = 106) groups.
resultsEncephalopathy attributable to causes other than hypoxia-ischemia at birth was not noted. Inotropic support (hypothermia, 59% of infants; control, 56% of infants) was similar during the 72-hour study intervention period in both groups. Need for blood transfusions (hypothermia, 24%; control, 24%), platelet transfusions (hypothermia, 20%; control, 12%), and volume expanders (hypothermia, 54%; control, 49%) was similar in the 2 groups. Among infants with persistent pulmonary hypertension (hypothermia, 25%; control, 22%), nitric-oxide use (hypothermia, 68%; control, 57%) and placement on extracorporeal membrane oxygenation (hypothermia, 4%; control, 9%) was similar between the 2 groups. Non-central nervous system organ dysfunctions occurred with similar frequency in the hypothermia (74%) and control (73%) groups. Rehospitalization occurred among 27% of the infants in the hypothermia group and 42% of infants in the control group. At 18 months, the hypothermia group had 24 deaths, 19 severe disabilities, and 2 moderate disabilities, whereas the control group had 38 deaths, 25 severe disabilities, and 1 moderate disability. Growth parameters were similar between survivors. No adverse outcomes were noted among infants receiving hypothermia with transient reduction of temperature below a target of 33.5 degrees C at initiation of cooling. There was a trend in reduction of frequency of all outcomes in the hypothermia group compared with the control group in both moderate and severe encephalopathy categories.
conclusionsAlthough not powered to test these secondary outcomes, whole-body hypothermia in infants with encephalopathy was safe and was associated with a consistent trend for decreasing frequency of each of the components of disability.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.