Evidence map›Paper›PMID 29637198›Full record

ArticleBMJ paediatrics open2018

Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device.

Vânia Oliveira, Jaya Raman Kumutha, Narayanan E, Jagadish Somanna, Naveen Benkappa, Prathik Bandya, Manigandan Chandrasekeran, Ravi Swamy, Jayashree Mondkar, Kapil Dewang and 15 more

Registry-linked trialAbstract read
In one paragraph

Article in BMJ paediatrics open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01760629 (Hypothermia for Encephalopathy in Low Income Countries-Feasibility), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT01760629 nacompletednot on this map

Hypothermia for Encephalopathy in Low Income Countries-Feasibility

TypeinterventionalSponsorThayyil, SudhinRan2013 to 2014Enrolled62ConditionsNeonatal EncephalopathyArmsTecotherm-HELIX
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Vânia Oliveira *Centre for Perinatal Neuroscience, Imperial College London, London, UK.
Jaya Raman Kumutha *Neonatal Medicine, Institute of Child Health, Madras Medical College, Chennai, Tamil Nadu, India.
Narayanan ENeonatal Medicine, Institute of Child Health, Madras Medical College, Chennai, Tamil Nadu, India.
Jagadish SomannaNeonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Naveen BenkappaNeonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Prathik BandyaNeonatal Medicine, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Manigandan ChandrasekeranNeonatal Medicine, Cloudnine Hospital, Chennai, Tamil Nadu, India.
Ravi SwamyCentre for Perinatal Neuroscience, Imperial College London, London, UK.
Jayashree MondkarNeonatal Medicine, Lokmanya Tilak Municipal Hospital, Sion, Mumbai, India.
Kapil DewangNeonatal Medicine, Lokmanya Tilak Municipal Hospital, Sion, Mumbai, India.
Swati ManerkarNeonatal Medicine, Lokmanya Tilak Municipal Hospital, Sion, Mumbai, India.
Mangalabharathi SundaramNeonatal Medicine, Institute of Child Health, Madras Medical College, Chennai, Tamil Nadu, India.
Kamalaratnam ChinathambiNeonatal Medicine, Institute of Child Health, Madras Medical College, Chennai, Tamil Nadu, India.
Shruti BharadwajNeonatal Medicine, Jawaharlal Institute of Postgraduate Medical Education & Research, Pondicherry, India.
Vishnu BhatNeonatal Medicine, Jawaharlal Institute of Postgraduate Medical Education & Research, Pondicherry, India.
Vijayakumar MadhavaNeonatal Medicine, Calicut Medical College, Kozhikode, Kerala, India.
Mohandas NairNeonatal Medicine, Calicut Medical College, Kozhikode, Kerala, India.
Peter James LallyCentre for Perinatal Neuroscience, Imperial College London, London, UK.
Paolo MontaldoCentre for Perinatal Neuroscience, Imperial College London, London, UK.
Gaurav AtrejaNeonatal Medicine, Imperial College Healthcare NHS Trust, London, UK.
Josephine MendozaCentre for Perinatal Neuroscience, Imperial College London, London, UK.
Paul BassettMedical Statistics, Stats Consultancy, London, UK.
Siddarth RamjiNeonatal Medicine, Maulana Azad Medical College, New Delhi, Delhi, India.
Seetha ShankaranNeonatal Medicine, Wayne State University, Detroit, Michigan, USA.
Sudhin ThayyilCentre for Perinatal Neuroscience, Imperial College London, London, UK.

Funding

Department of Health HCS DRF-2014-05-013Department of Health ICA-CDRF-2016-02-071Department of Health NIHR/CS/010/022Medical Research Council MR/R001375/1
6 · The paper itself

Abstract

Although therapeutic hypothermia (TH) is the standard of care for hypoxic ischaemic encephalopathy in high-income countries, the safety and efficacy of this therapy in low-income and middle-income countries (LMICs) is unknown. We aimed to describe the feasibility of TH using a low-cost servo-controlled cooling device and the short-term outcomes of the cooled babies in LMIC.

designWe recruited babies with moderate or severe hypoxic ischaemic encephalopathy (aged <6 hours) admitted to public sector tertiary neonatal units in India over a 28-month period. We administered whole-body cooling (set core temperature 33.5°C) using a servo-controlled device for 72 hours, followed by passive rewarming. We collected the data on short-term neonatal outcomes prior to hospital discharge.

resultsEighty-two babies were included-61 (74%) had moderate and 21 (26%) had severe encephalopathy. Mean (SD) hypothermia cooling induction time was 1.7 hour (1.5) and the effective cooling time 95% (0.08). The mean (SD) hypothermia induction time was 1.7 hour (1.5 hour), core temperature during cooling was 33.4°C (0.2), rewarming rate was 0.34°C (0.16°C) per hour and the effective cooling time was 95% (8%). Twenty-five (51%) babies had gastric bleeds, 6 (12%) had pulmonary bleeds and 21 (27%) had meconium on delivery. Fifteen (18%) babies died before discharge from hospital. Heart rate more than 120 bpm during cooling (P=0.01) and gastric bleeds (P<0.001) were associated with neonatal mortality.

conclusionsThe low-cost servo-controlled cooling device maintained the core temperature well within the target range. Adequately powered clinical trials are required to establish the safety and efficacy of TH in LMICs. CLINICAL TRIAL REGISTRATION NUMBER: NCT01760629.

Indexed as

brain injuryencephalopathyhypothermialow and middle-incomeneonatology

Identifiers

PMID29637198
PMCPMC5887762

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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.