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Status:

UNKNOWN

Optimising the Duration of Cooling in Mild Encephalopathy

Lead Sponsor:

Thayyil, Sudhin

Collaborating Sponsors:

Wayne State University

Conditions:

Neonatal Encephalopathy

Hypothermia Neonatal

Eligibility:

All Genders

Up to 6 years

Phase:

NA

Brief Summary

Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.

Detailed Description

Although therapeutic hypothermia for 72 hours reduces brain injury and improves long term neurodevelopmental outcomes after moderate or severe neonatal encephalopathy, the benefits and optimal duratio...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • All of the following three criteria should be met:
  • Age less than six hours. AND
  • Evidence of acute perinatal asphyxia
  • Metabolic acidosis (pH \<7.0 and/or BE \>-16) in cord gas or a blood gas within one of birth.
  • OR
  • If the pH or BE is borderline (pH\<7.15 to 7.0) and/or BE \>-10 to -16) in cord and/or blood gas within 1h of birth additional evidence of perinatal asphyxia is required, which includes either an acute obstetric event (e.g. cord prolapse, abruption, shoulder dystocia) OR Need for continued resuscitation or ventilation at 10 minutes and/or a 10 min Apgar score \<6
  • Evidence of mild NE (at-least two abnormalities) on an NICHD neurological examination performed between 1 and 6h of birth.
  • EXCLUSION CRITERIA
  • The following group of babies will be excluded prior to randomisation
  • Babies without encephalopathy
  • Babies with moderate or severe encephalopathy who meet the current NICE/AAP guidelines for cooling therapy.
  • Babies with seizures (clinical and/or aEEG/EEG)
  • Babies with moderate or severe abnormalities on aEEG voltage criteria.
  • Babies with life threatening congenital malformations

Exclusion

    Key Trial Info

    Start Date :

    October 10 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 30 2024

    Estimated Enrollment :

    140 Patients enrolled

    Trial Details

    Trial ID

    NCT03409770

    Start Date

    October 10 2019

    End Date

    August 30 2024

    Last Update

    August 4 2023

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Wayne State University

    Michigan Center, Michigan, United States, 48202

    2

    Luigi Vanvitelli Hospital

    Naples, Italy

    3

    Birmingham Womens Hospital

    Birmingham, United Kingdom

    4

    Medway NHS Foundation Trust

    Gillingham, United Kingdom