NCT06394453 Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
| NCT ID | NCT06394453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutricia Foundation |
| Condition | Newborn Asphyxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2024-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Viktoryia Parfenchyk, MD
PRINCIPAL INVESTIGATOR
Collegium Medicum Jagiellonian University in Cracow
Frequently Asked Questions
Who can join the NCT06394453 clinical trial?
This trial is open to participants of all sexes, up to 6 Hours, studying Newborn Asphyxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06394453 currently recruiting?
Yes, NCT06394453 is actively recruiting participants. Contact the research team at viktoryia.parfenchyk@uj.edu.pl for enrollment information.
Where is the NCT06394453 trial being conducted?
This trial is being conducted at Cracow, Poland.
Who is sponsoring the NCT06394453 clinical trial?
NCT06394453 is sponsored by Nutricia Foundation. The principal investigator is Viktoryia Parfenchyk, MD at Collegium Medicum Jagiellonian University in Cracow. The trial plans to enroll 104 participants.