Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Public ClinicalTrials.gov record NCT07372898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07372898
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Week to 8 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2025
- Primary completion
- Dec 30, 2026
- Completion
- Mar 29, 2027
- Last update posted
- Jan 27, 2026
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | 60611 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07372898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07372898 live on ClinicalTrials.gov.