Publications

BibTex format

@article{Thayyil:2021:10.1016/S2214-109X(21)00264-3,
author = {Thayyil, S and Pant, S and Montaldo, P and Shukla, D and Oliveira, V and Ivain, P and Bassett, P and Swami, R and Mendoza, J and Moreno-Morales, M and Lally, PJ and Benakappa, N and Bandiya, P and Shivarudhrappa, I and Somanna, J and Kantharajanna, UB and Rajvanshi, A and Krishnappa, S and Joby, PK and Jayaraman, K and Chandramohan, R and Kamalarathnam, CN and Sebastian, M and Tamilselvam, I and Rajendran, U and Soundrarajan, R and Kumar, V and Sudarsanan, H},
doi = {10.1016/S2214-109X(21)00264-3},
journal = {The Lancet Global Health},
pages = {e1273--e1285},
title = {Hypothermia for moderate or severe neonatal encephalopathy in low and middle-income countries (HELIX): a randomised control trial in India, Sri Lanka and Bangladesh},
url = {http://dx.doi.org/10.1016/S2214-109X(21)00264-3},
volume = {9},
year = {2021}
}

Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background: Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low- and middle-income countries (LMICs) remains unclear. We examined if therapeutic hypothermia alongside optimal supportive intensive care reduces death or disability after neonatal encephalopathy in South Asia. Methods: We conducted a multi-country open label randomised controlled trial involving seven tertiary neonatal intensive care units in India, Sri Lanka and Bangladesh, between August 2015 and September 2020. We allocated infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy into whole body hypothermia (33·5  0  C) for 72 hours using a servo-controlled cooling device, or usual care (control group), within six hours of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support and access to 3 Telsa magnetic resonance imaging and spectroscopy. The primary outcome was a combined end point of death or moderate or severe disability at 18 to 22 months of age, assessed by Bayley scales  of infant development (Version III).Findings: Of 576 eligible infants, we assigned 202 to hypothermia and 206 to control group. Primary outcome data were available for 394 (96·5%) infants, and occurred in 98(50·3%) of the hypothermia and 94 (47·2%) of the control group (Risk Ratio (RR) 1·06;95% confidence intervals (CI) 0·87 to 1·30 (p = 0·55). Eighty-four infants (42·4%) in the hypothermia group and 63 (31·3%) (p = 0·02) infants in the control group died, of whom 72 (35·6%) and 49 (23·8%) (p = 0·009) died during neonatal hospitalisation. Interpretation: Therapeutic hypothermia did not reduce the combined outcome of death or disability at18 months after neonatal encephalopathy in LMICs, but significantly increased mortality. Therapeutic hypothermia should not
AU  - Thayyil,S
AU  - Pant,S
AU  - Montaldo,P
AU  - Shukla,D
AU  - Oliveira,V
AU  - Ivain,P
AU  - Bassett,P
AU  - Swami,R
AU  - Mendoza,J
AU  - Moreno-Morales,M
AU  - Lally,PJ
AU  - Benakappa,N
AU  - Bandiya,P
AU  - Shivarudhrappa,I
AU  - Somanna,J
AU  - Kantharajanna,UB
AU  - Rajvanshi,A
AU  - Krishnappa,S
AU  - Joby,PK
AU  - Jayaraman,K
AU  - Chandramohan,R
AU  - Kamalarathnam,CN
AU  - Sebastian,M
AU  - Tamilselvam,I
AU  - Rajendran,U
AU  - Soundrarajan,R
AU  - Kumar,V
AU  - Sudarsanan,H
DO  - 10.1016/S2214-109X(21)00264-3
EP  - 1285
PY  - 2021///
SN  - 2214-109X
SP  - 1273
TI  - Hypothermia for moderate or severe neonatal encephalopathy in low and middle-income countries (HELIX): a randomised control trial in India, Sri Lanka and Bangladesh
T2  - The Lancet Global Health
UR  - http://dx.doi.org/10.1016/S2214-109X(21)00264-3
UR  - https://www.sciencedirect.com/science/article/pii/S2214109X21002643?via%3Dihub
UR  - http://hdl.handle.net/10044/1/90153
VL  - 9
ER  -

Download

DrPaoloMontaldo

Contact

Location

Summary

Citation

BibTex format

RIS format (EndNote, RefMan)