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NCT07372898 · ClinicalTrials.gov registry record · NA
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
A NA study of Oral Feeding Outcomes and Neurodevelopment Outcome, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07372898: Recruiting NA study of Oral Feeding Outcomes and Neurodevelopment Outcome, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT07372898 is a NA study of Oral Feeding Outcomes and Neurodevelopment Outcome that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07372898, a NA study of Oral Feeding Outcomes and Neurodevelopment Outcome, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Pre-feeding state observed by trained observers in feeding video. One pre-feeding behavioral state will be assigned using the following scale 1) Quiet sleep, 2) Active sleep, 3) Drowsy, 4) Quiet alert, 5) Active alert, or 6) Crying.
Conditions Studied
Interventions
- BEHAVIORAL H-HOPE
Study Locations (1)
Illinois
- Ann & Robert H Lurie Children's Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-07-31 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
What NCT07372898 shows while recruiting
NCT07372898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Oral Feeding Outcomes appearing as the primary indexed condition, and to 1 intervention - of which H-HOPE is the first listed.
NCT07372898 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT07372898 about?
NCT07372898 is a clinical study titled "Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)". 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...
What is the current status of trial NCT07372898?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2025-07-31. Estimated completion is 2027-03-30.
What conditions does trial NCT07372898 study?
This clinical trial studies the following conditions: Oral Feeding Outcomes, Neurodevelopment Outcome.
What interventions are being tested in trial NCT07372898?
The interventions under investigation include: H-HOPE (BEHAVIORAL).
Who is sponsoring clinical trial NCT07372898?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07372898 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07372898's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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