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Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy

RecruitingNAAges any - 6 HoursAllNutricia Foundation
NCT06394453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 of ≤5 * Ongoing resuscitation initiated at birth and continued for ≥10 minutes 4. Moderate to severe encephalopathy on clinical examination, using a Thompson HIE score ≥ 7 5. Signed informed consent by parent Exclusion Criteria: 1. Critical general condition 2. Aneuploidies (13 th , 18 th , 21 st ) 3. Birth weight \<1800 g 4. Severe congenital defects with poor prognosis 5. Severe mechanical head injuries 6. Congenital malformations of digestive system (esophageal atresia, duodenal atresia, gastroschisis, omphalocele, anal atresia)
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What it tests

  • enteral feeding with mother milk or human donor breast milk
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Where

1 site
University Children's Hospital of Cracow, Neonatal intensive care unit
Cracow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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