Actively Recruiting
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Led by Nutricia Foundation · Updated on 2024-05-01
104
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day, 30 ml/kg/day during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.
CONDITIONS
Official Title
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age of 35 weeks or more
- Less than 6 hours old after birth
- Presence of at least one of the following: metabolic or mixed acidosis with pH ≤7.0 or base deficit ≥16 mmol/L in blood within first hour after birth; 10-minute Apgar score ≤5; ongoing resuscitation at birth continued for 10 minutes or more
- Moderate to severe encephalopathy on clinical exam with Thompson HIE score ≥7
- Signed informed consent from parent
You will not qualify if you...
- Critical general condition
- Presence of aneuploidies (chromosomes 13, 18, or 21)
- Birth weight less than 1800 grams
- Severe congenital defects with poor prognosis
- Severe mechanical head injuries
- Congenital malformations of digestive system such as esophageal atresia, duodenal atresia, gastroschisis, omphalocele, or anal atresia
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Children's Hospital of Cracow, Neonatal intensive care unit
Cracow, Poland, 30-663
Actively Recruiting
Research Team
V
Viktoryia Parfenchyk, MD
CONTACT
M
Matuesz Jagla, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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