Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Recruiting
N/A
Interventional Study
Newborn Asphyxia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 6 Hours
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 104 (estimated)
- Sponsor
- Nutricia Foundation · Other
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About This Trial
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during T…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 35 weeks or more gestational age
2. \< 6 hours post birth
3. Any of the following:
* Metabolic or mixed acidosis with a pH of ≤7.0 or a base deficit ≥16 mmol/L in an umbilical cord blood sample or any blood obtained within first hour after birth
* 10-minute Apgar score…
Contacts