Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes. Early relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standard ICU care for infants born with a congenital defect requiring neonatal surgery, and their parents. The main questions to be answered include: 1. Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery? 2. Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery? 3. Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery? 4. Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents? 5. Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents? 6. Do parents of infants born with congenital defects requiring surgery experience participating in the H-HOPE intervention positively? Results of this study may provide preliminary evidence supporting use of H-HOPE to positively impact short- and long-term outcomes for these infants and their parents.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Infant pre-feeding behavioral state
Timeframe: At completion of intervention period, an average of 4 weeks
Infant pre-feeding behavioral cues
Timeframe: At completion of intervention period, an average of 4 weeks
Infant oral feeding progression
Timeframe: Through completion of intervention period, an average of 4 weeks
Infant growth
Timeframe: Through completion of intervention period, an average of 4 weeks
Infant neuroendocrine function
Timeframe: At completion of intervention period, an average of 4 weeks
Infant motor development
Timeframe: At completion of intervention period, an average of 4 weeks.
Infant gross motor, fine motor, communication, problem solving, personal-social neurodevelopment
Timeframe: At 3-4 months infant post-menstrual age
Infant feeding outcomes at home
Timeframe: At 3-4 month infant post-menstrual age