Feeding infants during therapeutic hypothermia for brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effects of enteral feeding during therapeutic hypothermia in infants diagnosed with hypoxic-ischaemic encephalopathy (HIE). It is a multicenter, randomized controlled trial conducted in level III neonatal intensive care units in southern Poland. Infants eligible for therapeutic hypothermia will be randomly assigned to either a fed group, receiving human milk, or an unfed control group during the 72-hour cooling period. The primary outcomes include the incidence of necrotizing enterocolitis or death and the length of hospital stay.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Children's Hospital of Cracow, Neonatal intensive care unit
  Cracow, Poland Recruiting

Study contacts

• Principal investigator: Viktoryia Parfenchyk, MD — Collegium Medicum Jagiellonian University in Cracow
• Study coordinator: Viktoryia Parfenchyk, MD
• Email: viktoryia.parfenchyk@uj.edu.pl
• Phone: +48 535275959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.