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Prevention of Epilepsy by Reducing Neonatal Encephalopathy (PREVENT)

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ClinicalTrials.gov Identifier: NCT04054453
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
University College, London
University of Oxford
University of Manchester
Madras Medical College
Bangalore Medical College and Research Institute
Government Medical College, Kozhikode
Information provided by (Responsible Party):
Thayyil, Sudhin

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.


Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Epilepsy Newborn Morbidity Combination Product: Intra-partum care bundle invoking 4 elements Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Interrupted Time Series Evaluation
Masking: Single (Outcomes Assessor)
Masking Description: Magnetic resonance biomarkers will be quantified masked to the interventional group
Primary Purpose: Prevention
Official Title: Prevention of Epilepsy by Reducing Neonatal Encephalopathy
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
No Intervention: Pre-intervention
Baseline data on neonatal encephalopathy and epilepsy before the introduction of the care bundle
Experimental: Post-intervention
Baseline data on neonatal encephalopathy and epilepsy after the introduction of the care bundle
Combination Product: Intra-partum care bundle invoking 4 elements
Care bundle involving all the 4 elements
Other Names:
  • Birth companion
  • Intelligent fetal heart rate monitoring by graphic doppler
  • Electronic partogram
  • Brain oriented neonatal resuscitation




Primary Outcome Measures :
  1. Epilepsy [ Time Frame: 18 months of age ]
    Two of more unprovoked seizures at least 24 hours apart


Secondary Outcome Measures :
  1. Neonatal encephalopathy [ Time Frame: 24 hours of birth ]
    Moderate or severe neonatal encephalopathy

  2. Neonatal Seizures [ Time Frame: 1 month of age ]
    Definite or probable seizures as per ILAE classification

  3. Thalamic N-aspartate levels [ Time Frame: 2 weeks of age ]
    Proton MR spectroscopy thalamic NAA

  4. Brain injury on conventional MR imaging [ Time Frame: 2 weeks of age ]
    Significant basal ganglia, cortical or white matter injury



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All pregnant women delivering at 36 weeks or later

Exclusion Criteria:

  • Premature deliveries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054453


Contacts
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Contact: Sudhin Thayyil, MD, PhD 00447912888700 s.thayyil@imperial.ac.uk
Contact: Stuti Pant, MSc

Locations
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India
Institute of Obstetrics and Gynaecology
Chennai, TamilNadu, India
Bangalore Medical College Not yet recruiting
Bangalore, India
Contact: Savitha Chandraih, MD         
Calicut Medical College Not yet recruiting
Calicut, India
Contact: Mini Chenicheri, MD         
Principal Investigator: Mini Chenicheri, MD         
Sub-Investigator: Noorul Amin, MD         
Sub-Investigator: Salah Basheer, MD         
Sub-Investigator: Krishna Kumar, MD         
United Kingdom
Sudhin Thayyil
London, United Kingdom
Sponsors and Collaborators
Thayyil, Sudhin
University College, London
University of Oxford
University of Manchester
Madras Medical College
Bangalore Medical College and Research Institute
Government Medical College, Kozhikode

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Responsible Party: Thayyil, Sudhin
ClinicalTrials.gov Identifier: NCT04054453     History of Changes
Other Study ID Numbers: NIHR200144
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases