Trial reportArchives of disease in childhood. Fetal and neonatal edition2020
Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled it.
What it found
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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
22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 59 citations in OpenAlex.
- Stem cell therapy in neonates with hypoxic-ischemic encephalopathy: a systematic review and meta-analysis.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025Pooled it
- Post-Asphyxial Aftercare and Management of Neonates in Low- and Middle-Income Countries: A Systematic Evidence Synthesis.Neonatology · 2025Pooled it
- A Systematic Review and Meta-Analysis of Therapeutic Hypothermia and Pharmacological Cotherapies in Animal Models of Ischemic Stroke.Therapeutic hypothermia and temperature management · 2024Pooled 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
- Trial
- Biochemical profiles and organ dysfunction in neonates with hypoxic-ischemic encephalopathy post-hoc analysis of the THIN trial.BMC pediatrics · 2024Trial
- Magnesium Sulfate as an Adjunct to Therapeutic Hypothermia in the Management of Term Infants with Hypoxic-Ischemic Encephalopathy: A Randomized, Parallel-Group, Controlled Trial.Indian journal of pediatrics · 2023Trial
- Trial
- Prediction of outcome from MRI and general movements assessment after hypoxic-ischaemic encephalopathy in low-income and middle-income countries: data from a randomised controlled trial.Archives of disease in childhood. Fetal and neonatal edition · 2022Trial
- Severe Hypokalemia Complicated by Wernicke's Encephalopathy and Hypoxic-Ischemic Brain Injury in Pregnancy: A Case from a Resource-Limited ICU.International medical case reports journal · 2026Article
- Meconium Aspiration Syndrome, Hypoxic-Ischemic Encephalopathy and Therapeutic Hypothermia-A Recipe for Severe Pulmonary Hypertension?Children (Basel, Switzerland) · 2024Review
- Therapeutic hypothermia after perinatal asphyxia in Vietnam: medium-term outcomes at 18 months - a prospective cohort study.BMJ paediatrics open · 2024Article
- Neonatal Resuscitation Practices in Romania: A Survey of the Romanian Association of Neonatology (ANR) and the Union of European Neonatal and Perinatal Societies (UENPS).Journal of critical care medicine (Universitatea de Medicina si Farmacie din Targu-Mures) · 2024Article
- Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review.PloS one · 2023Article
- Article
- Elevated serum IL-10 is associated with severity of neonatal encephalopathy and adverse early childhood outcomes.Pediatric research · 2022Article
- Review of a frugal cooling mattress to induce therapeutic hypothermia for treatment of hypoxic-ischaemic encephalopathy in the UK NHS.Globalization and health · 2022Review
- Therapeutic Hypothermia for Perinatal Asphyxia in Low-Resource Settings.Indian journal of pediatrics · 2022Article
- Rise and Fall of Therapeutic Hypothermia in Low-Resource Settings: Lessons from the HELIX Trial: Authors' Reply.Indian journal of pediatrics · 2022Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the neuroprotective effect of therapeutic hypothermia (TH) induced by phase changing material (PCM) on MRI biomarkers in infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting.
designOpen-label randomised controlled trial.
settingOne neonatal intensive care unit in a tertiary care centre in India. PATIENTS: 50 term/near-term infants admitted within 5 hours after birth with predefined physiological criteria and signs of moderate/severe HIE.
interventionsStandard care (n=25) or standard care plus 72 hours of hypothermia (33.5°C±0.5°C, n=25) induced by PCM.
main outcome measuresPrimary outcome was fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat.
resultsPrimary outcome was available for 22 infants (44%, 11 in each group). Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts. After adjusting for sex, birth weight and gestational age, the mean difference in PLIC FA between groups was 0.026 (95% CI 0.004 to 0.048, p=0.023). Conventional MRI was available for 46 infants and demonstrated significantly less moderate/severe abnormalities in the cooled (n=2, 9%) than in the non-cooled (n=10, 43%) infants. There was no difference in adverse events between groups.
conclusionsThis study confirmed that TH induced by PCM reduced brain injury detected on MRI in infants with moderate HIE in a neonatal intensive care unit in India. Future research should focus on optimal supportive treatment during hypothermia rather than looking at efficacy of TH in low-resource settings. TRIAL REGISTRATION NUMBER: CTRI/2013/05/003693.
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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.