The GAIN Study Early Feeding After Gastroschisis Surgery in Newborns up to 1 Year

What this Trial Is About

Researchers are evaluating the feasibility of starting early feeding in newborns with gastroschisis, a condition where the intestines develop outside the body. The study focuses on infants born at 34 weeks or later who have simple gastroschisis and are stable after surgery. This trial aims to understand if initiating feeds early is practical and how well infants tolerate and adhere to the feeding protocol. The study involves an early feeding protocol where human milk feeding begins within 48 hours of surgical repair and removal of the Replogle tube within 24 hours after abdominal closure. Feeds are gradually increased based on the infants tolerance and clinical assessments, with attention to supporting oral motor skill development. This intervention takes place from the prenatal period through hospital discharge, averaging about 90 days. Participants will be monitored closely from enrollment soon after birth until hospital discharge. Researchers will assess feasibility of enrollment, adherence to the feeding protocol, fidelity to the treatment plan, and reasons for any withdrawal from the protocol. The study also observes clinical stability throughout the feeding advancement period. Overall, the trial seeks to gather detailed information on the early feeding process and outcomes in this newborn population.

Early Feeds in Gastroschisis