Trial reportTrials2017
Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02387385 (Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial), which is not on this map. Cited by 27 papers, 1 of them a synthesis 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.
Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- Therapeutic hypothermia in neonatal hypoxic encephalopathy: A systematic review and meta-analysis.Journal of global health · 2022Pooled it
- Biochemical profiles and organ dysfunction in neonates with hypoxic-ischemic encephalopathy post-hoc analysis of the THIN trial.BMC pediatrics · 2024Trial
- Trial
- 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
- A national survey of therapeutic facilities for managing hypoxic ischaemic encephalopathy in tertiary neonatal wards in South African public hospitals.SAJCH : the South African journal of child health · 2025Article
- Article
- Congenital Varicella Syndrome and Crossed Nonfused Renal Ectopia in a Neonate: A Case Report.Cureus · 2025Article
- Translational Potential of Stem Cell-based Therapies in the Treatment of Neonatal Hypoxic-ischemic Brain Injury.Stem cell reviews and reports · 2025Review
- Mathematical Albumin Function for Neonates Undergoing Therapeutic Hypothermia in Comparison with Control Neonates.Journal of clinical pharmacology · 2025Article
- Pharmacokinetics of 7,8-dihydroxyflavone in neonatal mice with hypoxia-ischemia related brain injury.Frontiers in pharmacology · 2024Article
- Predictors of poor neurodevelopmental outcomes in neonates with clinically observed seizures: A prospective observational study in a tertiary care hospital of Bangladesh.Epilepsy & behavior reports · 2024Article
- Characteristics of neonatal hypoxic-ischemic encephalopathy at high altitude and early results of therapeutic hypothermia.BMC pediatrics · 2023Article
- A narrative review on treatment strategies for neonatal hypoxic ischemic encephalopathy.Translational pediatrics · 2023Review
- Elevated serum IL-10 is associated with severity of neonatal encephalopathy and adverse early childhood outcomes.Pediatric research · 2022Article
- Feasibility of EEG Phase-Amplitude Coupling to Stratify Encephalopathy Severity in Neonatal HIE Using Short Time Window.Brain sciences · 2022Article
- Rise and Fall of Therapeutic Hypothermia in Low-Resource Settings: Lessons from the HELIX Trial: Correspondence.Indian journal of pediatrics · 2022Article
- Neuroimaging in the term newborn with neonatal encephalopathy.Seminars in fetal & neonatal medicine · 2021Review
- Melatonin for Neonatal Encephalopathy: From Bench to Bedside.International journal of molecular sciences · 2021Review
- Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh.BMJ global health · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors at 8 institutions in 5 countries.
Funding
Abstract
backgroundTherapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs.
methodsWe will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection.
trial registrationClinicalTrials.gov, NCT02387385 . Registered on 27 February 2015.
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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.