Trial reportJournal of perinatology : official journal of the California Perinatal Association2018
Association between sedation-analgesia and neurodevelopment outcomes in neonatal hypoxic-ischemic encephalopathy.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Neonatal encephalopathy: a systematic review of reported treatment outcomes.BMJ paediatrics open · 2024Pooled it
- Pooled it
- Whole-Body Hypothermia vs Targeted Normothermia for Neonates With Mild Encephalopathy: A Multicenter Pilot Randomized Clinical Trial.JAMA network open · 2024Trial
- Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh.The Lancet. Global health · 2021Trial
- Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial.Archives of disease in childhood. Fetal and neonatal edition · 2020Trial
- Dexmedetomidine use in Infants undergoing Cooling due to neonatal Encephalopathy (DICE trial): safety and pharmacokinetics.Pediatric research · 2026Article
- Sedation and Pain Management in Neonates Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy.Children (Basel, Switzerland) · 2025Review
- Whole-body hypothermia in mild neonatal encephalopathy: protocol for a multicentre phase III randomised controlled trial.BMC pediatrics · 2024Article
- Sequential levetiracetam and phenytoin in electroencephalographic neonatal seizures unresponsive to phenobarbital: a multicenter prospective observational study in India.The Lancet regional health. Southeast Asia · 2024Article
- Effectiveness and Safety of Dexmedetomidine in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Short-term effects of opioids during therapeutic hypothermia for neonatal encephalopathy.Frontiers in pediatrics · 2024Article
- Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes.Frontiers in pediatrics · 2023Article
- Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review.PloS one · 2023Article
- Neuroprotection for hypoxic-ischemic encephalopathy: Contributions from the neonatal research network.Seminars in perinatology · 2022Review
- Clonidine for sedation in infants during therapeutic hypothermia with neonatal encephalopathy: pilot study.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Prognostic value of neonatal EEG following therapeutic hypothermia in survivors of hypoxic-ischemic encephalopathy.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2021Article
- Treating Seizures after Hypoxic-Ischemic Encephalopathy-Current Controversies and Future Directions.International journal of molecular sciences · 2021Review
- Morphine and fentanyl exposure during therapeutic hypothermia does not impair neurodevelopment.EClinicalMedicine · 2021Article
- Emerging therapies and management for neonatal encephalopathy-controversies and current approaches.Journal of perinatology : official journal of the California Perinatal Association · 2021Review
- Practical approaches to sedation and analgesia in the newborn.Journal of perinatology : official journal of the California Perinatal Association · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the association between sedation-analgesia (SA) during initial 72 h and death/disability at 18 months of age in neonatal hypoxic-ischemic encephalopathy (HIE).
designThis was a secondary analysis of the NICHD therapeutic hypothermia (TH) randomized controlled trial in moderate or severe HIE. Receipt of SA and anticonvulsant medications at five time points were considered: prior to and at baseline, 24, 48, and 72 h of TH or normothermia. Disability was defined as mental developmental index <85, cerebral palsy, blindness, hearing impairment, or Gross Motor Function Classification System 2-5.
resultsOf the 208 RCT participants, 38 (18%) infants had no exposure to SA or anticonvulsants at any of the five time points, 20 (10%) received SA agents only, 81 (39%) received anticonvulsants only, and 69 (33%) received both SA and anticonvulsants. SA category drugs were not administered in 57% of infants while 18% received SA at ≥3 time points; 72% infants received anticonvulsants during 72 h of intervention. At 18 months of age, disability among survivors and death/disability was more frequent in the groups receiving anticonvulsants, with (48 and 65%) or without (37 and 58%) SA, compared to groups with no exposure (14 and 34%) or SA (13 and 32%) alone. Severe HIE (aOR 3.60; 1.59-8.13), anticonvulsant receipt (aOR 2.48; 1.05-5.88), and mechanical ventilation (aOR 7.36; 3.15-17.20) were independently associated with 18-month death/disability, whereas TH (aOR 0.28; 0.13-0.60) was protective. SA exposure showed no association with outcome.
conclusionsThe risk benefits of SA in HIE need further investigation.
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.