Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy: a Randomized Controlled Study.
Nutricia Foundation
104 participants
Apr 15, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- weeks or more gestational age
- \< 6 hours post birth
- 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
- minute Apgar score of ≤5
- Ongoing resuscitation initiated at birth and continued for ≥10 minutes
- Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7
- Signed informed consent by parent
Exclusion Criteria6
- Critical general condition
- Aneuploidies (13 th , 18 th , 21 st )
- Birth weight \<1800 g
- Severe congenital defects with poor prognosis
- Severe mechanical head injuries
- Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)
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Interventions
The experimental group will start enteral feeding with mother milk or human donor breast milk if mother milk is not accesible during the first day of therapeutic hypothermia.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06394453