BridgeMD
New treatment option for Neonatal Encephalopathy
Official title Cooling in Mild Encephalopathy
ClinicalTrials.gov ID: NCT05889507
What this study is testing
- What it's testing
- The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS. The main questions it aims to answer are: 1.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 6
You may be able to join if
- All babies born at or after 36 weeks of gestation with a birth weight of 1800g or more with birth acidosis or requiring resuscitation at birth will...
- Parents will be approached for consent if the baby meets all the three (A + B + C) criteria below:
- A. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of \ =16mmol/l in any cord or baby gas sample within 60 minutes of...
- B. Evidence of mild hypoxic ischaemic encephalopathy defined as - two or more abnormal findings in any of the six categories of the modified Sarnat...
- C. Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the...
You likely can't join if
- Infants who meet the BAPM criteria for whole-body hypothermia
- Infants without encephalopathy defined as less than two abnormalities on structured neurological examination.
- Infants with major congenital or chromosomal anomalies identified prior to randomisation.
- Infants with birthweight \<1800g.
- Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
- Ashford, United Kingdom
- Birmingham, United Kingdom
- Bolton, United Kingdom
- Bradford, United Kingdom
- Brighton, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Coventry, United Kingdom
- Dartford, United Kingdom
- Edinburgh, United Kingdom
- Exeter, United Kingdom
- Gillingham, United Kingdom
- Haywards Heath, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Luton, United Kingdom
- Manchester, United Kingdom
+ 9 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 hour to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy; Ashford, United Kingdom; Birmingham, United Kingdom; Bolton, United Kingdom; Bradford, United Kingdom; Brighton, United Kingdom and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.