Real‐World Therapeutic Hypothermia for Neonatal HIE : Neurodevelopmental Outcomes and Predictors
Year: 2025
Type: article
Study design: Observational Study
Abstract: AIM: This study assessed neurodevelopmental outcomes in neonates with hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia (TH) outside randomised controlled trials (RCTs). It also aimed to identify predictors of outcomes and evaluate TH practices across centres. METHODS: A prospective, area-based observational study was conducted in eight Italian NICUs (2016-2021), including neonates treated with TH for any grade of HIE. A 2-year neurodevelopmental follow-up was performed. Severe functional disability (SFD) was defined as cerebral palsy (Gross Motor Function Classification Level > 2), cognitive score < 2 SD, bilateral blindness/deafness, or epilepsy. Demographic, clinical and MRI data were analysed. RESULTS: Among 283 cooled infants, 11 (3.8%) died and 272 (96.2%) survived. HIE severity was mild (14.0%), moderate (76.1%) and severe (9.9%). Follow-up data were available for 232 (85.3%) survivors, with SFD diagnosed in 27 (11.6%). No infants with mild HIE developed SFD. Severe MRI anomalies were found in 51.9% of SFD cases, while 90.7% of non-SFD children had normal findings. cEEG/aEEG-confirmed seizures (OR = 12.9, CI 3.5-65.0) and severe MRI anomalies (OR = 0.24, CI 0.13-0.44) were strong SFD predictors (AUC = 0.95). CONCLUSION: Mortality and SFD rates were lower than in RCTs. Seizures and severe MRI anomalies predicted poor outcomes. Further RCTs are needed to refine treatment criteria.
Source: Acta Paediatrica
DOI: 10.1111/apa.70186
Authors: Luca Bedetti, Licia Lugli, Isotta Guidotti, Maria Federica Roversi, Elisa Della Casa Muttini, Marisa Pugliese, Natascia Bertoncelli, Eugenio Spaggiari, Alessandra Todeschini, Gina Ancora, Sara Grandi, Giancarlo Gargano, Claudio Gallo, Mario Motta, Piero Catenazzi, Luigi Tommaso Corvaglia, Vittoria Paoletti, Agostina Solinas, Elisa Ballardini, Serafina Perrone, Sabrina Moretti, Marcello Stella, Alberto Berardi, Fabrizio Ferrari
Institutions: Azienda Ospedaliero-Universitaria di Modena, Ospedale Infermi di Rimini, Azienda Sanitaria Unità Locale di Reggio Emilia, Ospedale Maggiore Carlo Alberto Pizzardi, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, Arcispedale Sant'Anna, Ospedale di Parma, Ospedale “M. Bufalini” di Cesena
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,480
OpenAlex ID: W4411468960