Developmental intervention for newborns with congenital heart disease
Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease
This study is testing a special care approach for newborns with serious heart problems in the hospital to see if it helps their brain development and overall growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | N/A to 4 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05885113 on ClinicalTrials.gov |
What this trial studies
This study focuses on implementing an individualized developmental care (IDC) intervention for newborns diagnosed with complex congenital heart disease (CHD) who are admitted to the cardiac intensive care unit (CICU). The intervention aims to improve neurodevelopmental outcomes by minimizing the negative impacts of the hospital environment on the developing brain. Core components of IDC include family involvement in care, reducing infant stress during medical procedures, and creating a soothing environment to promote healing and growth. The study seeks to address the long-term neurodevelopmental disabilities often seen in survivors of CHD by providing tailored support and education to families at the bedside.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to the CICU at Boston Children's Hospital within three days of birth, diagnosed with complex CHD requiring open heart surgery within the first two weeks of life.
Not a fit: Patients who have severe associated extracardiac anomalies or have previously undergone cardiac surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance neurodevelopmental outcomes and overall well-being for infants with congenital heart disease.
How similar studies have performed: While few rigorous studies have tested similar interventions, existing literature suggests that minimizing environmental stressors can improve neurodevelopmental outcomes in critically ill infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * admitted to the Cardiac Intensive Care Unit (CICU) at Boston Children's Hospital (BCH) within 3 days of birth * diagnoses of complex CHD with need for open heart surgery within the first two weeks of life (for example: total anomalous pulmonary venous connection, transposition of the great arteries, truncus arteriosus, VSD with interrupted aortic arch) * free from associated extracardiac anomalies that are moderate or severe * free from previous cardiac surgery or associated cardiovascular anomalies * GA greater than 37 weeks * 1 and 5 minute Apgar ≥ 4 * free of known chromosomal and congenital abnormalities (e.g., Down syndrome, 22q11 deletion, Noonan syndrome, Williams syndrome) * free from multiple congenital anomalies (e.g., CHARGE syndrome) * mother's age ≥ 20 ≤ 45 years * absence of reported maternal alcohol, nicotine, or illegal drug use by maternal report and medical record review * telephone/internet access. Exclusion Criteria: * Patients who experience cardiac arrest, CPR, ECMO, or VAD prior to recruitment
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Samantha Butler, PhD — Boston Children's Hospital
- Study coordinator: samantha butler, PhD
- Email: samantha.butler@childrens.harvard.edu
- Phone: 6173557483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.