RecruitingNot ApplicableNCT06394453

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.


Sponsor

Nutricia Foundation

Enrollment

104 participants

Start Date

Apr 15, 2024

Study Type

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

Max Age: 6 Hours

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying enteral feeding with mother milk or human donor breast milk for people with newborn asphyxia. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 6 Hours.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERenteral feeding with mother milk or human donor breast milk

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)

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

Cracow, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06394453


Related Trials