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NCT05885113 · ClinicalTrials.gov registry record · NA
Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease
A NA study, sponsored by Boston Children's Hospital.
- Active
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT05885113: Active NA study, sponsored by Boston Children's Hospital.
NCT05885113 is a NA study that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05885113, a NA study, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart disease (CHD) with improved parent well-being. Literature documents long-term ND disabilities for children with CHD, caused by the negative effects of the hospital environment on the developing newborn brain. The cardiac intensive care unit (CICU), while necessary to save the life of the infant with CHD, exposes infants to overwhelming stress through painful procedures, invasive lines and tubes, toxic sensory stimulation, and separation from family. The combination of these negative experiences disrupts the infant's brain maturation and subsequent neurodevelopment. Individualized developmental care (IDC) is an intervention that minimizes the mismatch between infant neurobiological needs and the harsh hospital environment, thereby diminishing the frequency and severity of adverse effects. Core components of IDC include support for parent engagement, caregiving provided in a way to reduce infant stress, providing a soothing environment and appropriately positioning to enhance musculoskeletal and motor development. Research shows that IDC improves outcomes for preterm infants with enhanced brain structure and function, cognitive skills, executive functioning, behavioral outcomes, and family satisfaction from infancy to school age. Despite all the positive evidence for IDC, my past research showed most CICUs do not implement IDC due to lack of staff education and no evidence supporting IDC in CHD. The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD. The investigators hypothesize infants receiving IDC provided in the hospital, compared to those not receiving IDC, will show improved medical outcomes (including shorter hospital stay, improved oral feeding, increased growth), improved developmental competence, and increased parent coping
Primary Outcome
Measure of Developmental Care in the hospital at the bedside; 0-5 with 5 being the best score.
Interventions
- BEHAVIORAL NIDCAP Developmental Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-10-10 |
| Est. Completion | 2027-08-01 |
| Phase | NA |
What the registry record for NCT05885113 still lists
NCT05885113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which NIDCAP Developmental Care is the first listed.
NCT05885113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05885113 about?
NCT05885113 is a clinical study titled "Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease". The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart disease (CHD) with improved parent well-being. Literature documents long-term ND disabilities for children with CHD, caused by the negative effec...
What is the current status of trial NCT05885113?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 34 participants. The study started on 2023-10-10. Estimated completion is 2027-08-01.
What interventions are being tested in trial NCT05885113?
The interventions under investigation include: NIDCAP Developmental Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT05885113?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05885113's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 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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