NCT05471336

Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)

A Prospective Study Describing Splanchnic NIRS Values in Infants With Neonatal Encephalopathy Undergoing Therapeutic Hypothermia and Receiving Enteral Feeds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 0 Days – 2 Days
• Healthy volunteers: Not accepted

Summary

The research team plans to administer trophic enteral feeds to infants with Neonatal Encephalopathy that are undergoing therapeutic hypothermia. The team will monitor splanchnic NIRS values and compare these values to a group of historic infants who underwent hypothermia but did not receive feeds, to investigate whether there may be a range of values that can predict safe feeding. The team will also look at some clinical outcomes including feeding tolerance, time to achieve full enteral feeds, infection rates, length of hospital stay.

Conditions

• Neonatal Encephalopathy

Interventions

Type	Name	Description
PROCEDURE	Enteral Feeding	Feeds of expressed breast milk or donor breast milk will be given. Formula feeds will not be permitted. If the parents do not wish to provide donor milk, whatever volume of expressed mother's milk is available will be given up until the required volume. Feeds will be administered via orogastric or nasogastric tube and administered over 30 minutes.

Timeline

• Start date: 2022-09-09
• Primary completion: 2024-02-07
• Completion: 2024-03-14
• First posted: 2022-07-22
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States