Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

Launched by BOSTON CHILDREN'S HOSPITAL · May 22, 2023

Keywords

ClinConnect Summary

**Trial Summary: Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease**

This clinical trial aims to improve the health and development of newborns with congenital heart disease (CHD) while also supporting their parents. Congenital heart disease refers to heart problems that are present at birth. Newborns with this condition often require special care in a cardiac intensive care unit (CICU), where they can experience stress from medical procedures and being separated from their families. The trial will test an approach called individualized developmental care (IDC), which focuses on creating a nurturing environment that supports the baby’s needs, reduces stress, and encourages parent involvement. Researchers believe that babies receiving IDC will show better health outcomes, such as shorter hospital stays and improved growth and feeding, compared to those who do not receive this care.

Eligible participants for this trial include newborns admitted to the CICU at Boston Children's Hospital within three days of birth and diagnosed with specific complex heart defects needing surgery soon after birth. To be included, the babies must be over 37 weeks old and have certain health criteria. During the trial, families can expect to be involved in their baby's care and to receive support that helps them cope with the challenges of having a child with CHD. This study is important because it could lead to better care practices in hospitals for infants with heart conditions and improve outcomes for families affected by CHD.

Gender

ALL

Eligibility 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