Feeding infants during therapeutic hypothermia for brain injury
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy: a Randomized Controlled Study.
This study tests if feeding infants with brain injuries during cooling treatment is safe and helps them recover better than not feeding them at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | N/A to 6 Hours |
| Sex | All |
| Sponsor | Nutricia Foundation Academic / other |
| Locations | 1 site (Cracow) |
| Trial ID | NCT06394453 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants born at 35 weeks or more gestational age, under 6 hours old, with moderate to severe HIE.
Not a fit: Patients with critical general conditions, severe congenital defects, or low birth weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for infants with HIE by demonstrating that enteral feeding during therapeutic hypothermia is safe and beneficial.
How similar studies have performed: While the approach of feeding during therapeutic hypothermia is not widely tested, existing studies suggest potential benefits, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Cracow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.