Prevention of Epilepsy by Reducing Neonatal Encephalopathy

NCT04054453 | Unknown

• 1 other identifier: NIHR200144
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Neonatal Encephalopathy; Epilepsy; Newborn Morbidity

Outcome Measures

Primary Outcomes (1)

• Epilepsy

  Two of more unprovoked seizures at least 24 hours apart

  18 months of age

Secondary Outcomes (4)

• Neonatal encephalopathy

  24 hours of birth

• Neonatal Seizures

  1 month of age

• Thalamic N-aspartate levels

  2 weeks of age

• Brain injury on conventional MR imaging

  2 weeks of age

Study Arms (2)

Pre-intervention

NO INTERVENTION

Baseline data on neonatal encephalopathy and epilepsy before the introduction of the care bundle

Post-intervention

EXPERIMENTAL

Baseline data on neonatal encephalopathy and epilepsy after the introduction of the care bundle

Combination Product: Intra-partum care bundle invoking 4 elements

Interventions

Intra-partum care bundle invoking 4 elements COMBINATION_PRODUCT

Care bundle involving all the 4 elements

Also known as: Birth companion, Intelligent fetal heart rate monitoring by graphic doppler, Electronic partogram, Brain oriented neonatal resuscitation

Post-intervention

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pregnant women delivering at 36 weeks or later

You may not qualify if:

• Premature deliveries

Sponsors & Collaborators

• Thayyil, Sudhin: lead
• University College, London: collaborator
• University of Oxford: collaborator
• University of Manchester: collaborator
• Bangalore Medical College and Research Institute: collaborator
• Government Medical College, Kozhikode: collaborator
• Karnataka Institute of Medical Sciences: collaborator

Study Sites (4)

Bangalore Medical College

Bangalore, India

Location

Calicut Medical College

Calicut, India

Location

Karnataka Institute of Medical Sciences

Hubbali, India

Location

Sudhin Thayyil

London, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Magnetic resonance biomarkers will be quantified masked to the interventional group
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Interrupted Time Series Evaluation

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 13, 2019
• Study Start: March 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: October 30, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); GB (1)