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.
Real-World Therapeutic Hypothermia for Neonatal HIE: Neurodevelopmental Outcomes and Predictors / Bedetti, L.; Lugli, L.; Guidotti, I.; Roversi, M. F.; Muttini, E. D. C.; Pugliese, M.; Bertoncelli, N.; Spaggiari, E.; Todeschini, A.; Ancora, G.; Grandi, S.; Gargano, G.; Gallo, C.; Motta, M.; Catenazzi, P.; Corvaglia, L. T.; Paoletti, V.; Solinas, A.; Ballardini, E.; Perrone, S.; Moretti, S.; Stella, M.; Berardi, A.; Ferrari, F.. - In: ACTA PAEDIATRICA. - ISSN 0803-5253. - (2025). [10.1111/apa.70186]
Real-World Therapeutic Hypothermia for Neonatal HIE: Neurodevelopmental Outcomes and Predictors
Perrone S.;
2025-01-01
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
