Prevention of Epilepsy by Reducing Neonatal Encephalopathy

NIHR200144

The aim of the study is to examine if a pragmatic, evidenced based and generalisable intrapartum care bundle involving birth companions and empowering mothers will reduce birth injury-related epilepsy at 18 months of age in India. The care bundle will have four key elements (interventions): (1) birth companion providing constant 1:1 care during labour and early perinatal period; (2) fetal surveillance during active labour by a nurse or midwife using a graphic display Doppler; (3) labour management by an electronic partogram with an 'alert' and 'nag' feature based on the current WHO guidelines; (4) brain oriented early newborn care with resuscitation where indicated. The care bundle will be evaluated using a prospective interrupted time series design, recruiting 80,000 women delivering in one of the three participating centres in south India, over two years. Accurate baseline data will be collected during the first year and the optimised care bundle will be introduced during the second year. All full term newborn infants admitted to the neonatal unit with perinatal brain injury during both periods, will have detailed assessments including video electroencephalography, and magnetic resonance imaging, and will be followed up until 18 months of age. Primary outcome is the number of infants with epilepsy (categorised per current ILAE guidelines) at 18 months of age expressed as per 1000 term livebirths. The investigators will use a segmented logistic regression to divide the time series into pre- and post-intervention segments, with the intervention date as the intersection between segments. The difference in the two segments will be quantified using the level (step change) and slope (trend change). The total duration of the study is four years including 24 months of recruitment and 18 months of follow-up.

2020-03-01

2024-08-01

2024-10-30

Active (not recruiting)

2000

Inclusion Criteria: * All pregnant women delivering at 36 weeks or later Exclusion Criteria: * Premature deliveries

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Interrupted Time Series Evaluation', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Magnetic resonance biomarkers will be quantified masked to the interventional group', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ESTIMATED'}}

2023-08-04