Actively Recruiting
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-01-28
40
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born with a congenital defect requiring major neonatal surgery, including congenital heart disease, and one or both parents
- Infant less than 48 weeks post-menstrual age at start of H-HOPE
- Infant clinically stable with no vital sign instability during routine care
- Infant on respiratory support less than a nasal cannula at 2 liters per minute
- Infant off all intravenous pain medications
You will not qualify if you...
- Infants born before 34 weeks gestation
- Infants with congenital nervous system defects such as spina bifida or congenital hydrocephalus
- Infants with genetic syndromes
- Infants with history of Extracorporeal Membrane Oxygenation
- Infants with mechanical ventilation lasting 30 or more days
- Infants who are wards of the state
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Susan Horner, PhD
CONTACT
S
Steven M Ward, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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