ABSTRACT
Background
Although shown to reduce death or disability in moderate-to-severe hypoxic ischaemic encephalopathy (HIE), therapeutic hypothermia (TH) has recently been associated with an increase in adverse events in low- and middle-income countries (LMIC).
Aim
To determine the clinical characteristics, complications and short-term outcome in neonates receiving TH in King Edward Memorial Hospital, Mumbai, India.
Methods
A retrospective single-centre study of neonates with moderate-to-severe HIE who received TH from 1 January 2018 to 31 December 2021 was undertaken. TH was provided as per the unit’s protocol using either a servo-controlled device or a phase-changing material (PCM).
Results
One hundred and fifty-five neonates were included with 94.2% intramural births. Mean gestation and birthweight were 38.6 (1.5) weeks and 2776.7 (431) g, respectively. HIE staging was moderate in 87.1% and severe in 12.9%, with a mean cord pH of 6.93 (0.14) and seizures in 38.7%. Adverse events included shock (50.3%), clinically significant bleeding (16%), acute kidney injury (6.7%), culture-positive sepsis (11.6%), persistent pulmonary hypertension (9%), bradycardia (9%), food intolerance (14.9%) and premature termination (7.1%). A servo-controlled device (15.5%) or PCM (84.5%) was used, with comparable adverse events. 84.5% of the neonates were discharged, 7.1% discharged against medical advice and 8.4% died. Detailed neurological assessment at discharge/discharge against medical advice suggested neurological impairment in 128 (87.1%) neonates.
Conclusion
Adverse events during TH range from asymptomatic laboratory abnormalities to life-threatening complications, which are manageable in well equipped units. Neurological impairment at discharge in neonates who received cooling mandates strict neurological follow-up.
Abbreviations: aEEG: amplitude-integrated EEG; AKI: acute kidney injury; BW: birthweight; EEG: electro-encephalogram; GA: gestational age; HELIX: hypothermia for encephalopathy in low- and middle-income countries; HIE: hypoxic ischaemic encephalopathy; IVH: intraventricular haemorrhage; LMIC: low- and middle-income countries; NICHD: National Institute of Child Health and Human Development; NICU: neonatal intensive care unit; PPHN: persistent pulmonary hypertension of newborn; PCM: phase-changing material; SGA: small-for-gestational age; TH: therapeutic hypothermia.
Acknowledgments
The authors are grateful to Dr Sangeeta Ravat, Dean, Seth GS Medical College and KEM Hospital, Mumbai, for permission to publish.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Availability of data and material
De-identified patient datasets will be available upon written request to the corresponding author following publication.
Author contributions
Dwayne Mascarenhas, Medha Goyal and Ruchi Nanavati conceptualised and designed the study. Dwayne Mascarenhas, Medha Goyal, S. B. Kirthana and Santoshi Subhadarsini were involved with patient identification, data collection and data entry. Dwayne Mascarenhas, Medha Goyal, S. B. Kirthana, Santoshi Subhadarsini and Ruchi Nanavati undertook the statistical analysis and wrote the first draft of the manuscript. All authors have read and approved the final draft and agree to be accountable for all aspects of the work.