Condition: Oral Feeding Outcomes · Neurodevelopment Outcome · Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
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 interac…
This description comes directly from the study's public registry record.
Susan Horner, PhD · 16309158541 · shorner@luriechildrens.org
Steven M Ward, BS · 312.227-5064 · smward@luriechildrens.org
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| Ann & Robert H Lurie Children's Hospital | Chicago, Illinois, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07372898