Study of H-HOPE Intervention for Infants With Congenital Defects Needing Neonatal Surgery and Their Parents to Improve Feeding, Growth, and Development

What this Trial Is About

Researchers are evaluating the impact of the Hospital to Home Optimizing Preterm Infant Environment H-HOPE intervention compared to standard ICU care for infants born with congenital defects requiring major neonatal surgery and their parents. This study focuses on improving early feeding, growth, neurodevelopment, parental mental health, and parent-infant interactions. It addresses the challenges faced by these infants and parents, including risks of neurodevelopmental impairments and adverse mental health outcomes caused by hospitalization and stress exposures. The study involves randomly assigning 40 infants and their parents to either the H-HOPE intervention or standard ICU care. The H-HOPE intervention includes two parts Parents training for parents to learn infant behavioral cues and the Massage behavioral intervention, which parents provide twice daily. Massage involves talking, massaging, and providing visual and vestibular stimulation adapted to infant tolerance. Control group infants receive usual ICU care and parents are offered an infant care class unrelated to the study. Trained staff may provide Massage when parents are unavailable. Participants will be involved from enrollment when the infant is stable and on minimal respiratory support, continuing intervention for around 4 weeks until ICU discharge, with follow-up assessments at 3-4 months post-menstrual age. Researchers will measure infant feeding behaviors, oral feeding progression, growth, neuroendocrine function, motor and neurodevelopment outcomes, as well as parental mental health, cortisol levels, and parent-infant interactions. Safety and adherence will be monitored daily through logs documenting intervention frequency, infant tolerance, and parent presence.

Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)