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NCT04555590 · ClinicalTrials.gov registry record · NA
Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants
A NA study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 1,882
- Enrollment target
NCT04555590: Completed NA study, sponsored by Medical College of Wisconsin.
NCT04555590 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 1,882 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04555590, a NA study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,882 participants
- Enrollment target
Study Summary
Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offeri
Primary Outcome
Change in % of instances of H-HOPE being offered
Interventions
- BEHAVIORAL H-HOPE Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,882 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2024-11-05 |
| Phase | NA |
What the finished NCT04555590 record still lists
NCT04555590 is an interventional study that assigns participants to a tested intervention. Its 1,882 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 1 intervention - of which H-HOPE Intervention is the first listed.
NCT04555590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04555590 about?
NCT04555590 is a clinical study titled "Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants". Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Hom...
What is the current status of trial NCT04555590?
This trial is currently completed. It is a NA study. The enrollment target is 1,882 participants. The study started on 2020-11-16. Estimated completion is 2024-11-05.
What interventions are being tested in trial NCT04555590?
The interventions under investigation include: H-HOPE Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04555590?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04555590's enrollment target sits among peer trials
1,882 55th of 2000 higher than 1,946 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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