Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 34 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05885113
The ClinicalTrials.gov registry entry for NCT05885113 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NIDCAP Developmental Care is the first listed.
NCT05885113 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.