Optimising the Duration of Cooling in Mild Encephalopathy
Status unconfirmed · Not applicable
Conditions studied: Neonatal Encephalopathy, Hypothermia Neonatal, Magnetic Resonance Spectroscopy
In brief
Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.
Key facts
- Study ID
- NCT03409770
- Run by
- Thayyil, Sudhin
- People needed
- 140
- Starts
- 2019-10-10
- Expected to finish
- 2024-08-30
- Last updated by the study team
- 2023-08-04
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Wayne State University — Michigan Center, Michigan, United States
- Luigi Vanvitelli Hospital — Naples, Italy
- Birmingham Womens Hospital — Birmingham, United Kingdom
- Medway NHS Foundation Trust — Gillingham, United Kingdom
- Liverpool Womens Hospital — Liverpool, United Kingdom
- Homerton University Hospital — London, United Kingdom
- Imperial College London — London, United Kingdom
- The Newcastle Upon Tyne NHS Foundation Trust — Newcastle, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.