Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 at the time of discharge home and 3 months after discharge. With support from the Children's Heart Foundation, the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU, the potential to improve the ND outcome for infants with CHD and increase parent well-being. This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
samantha butler, PhD
samantha.butler@childrens.harvard.edu
6173557483
Backup
Katrina Severtson, BS
katrina.severtson@childrens.harvard.edu
6173553401
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 30
Treatments
Experimental: Intervention
NIDCAP developmental care group receiving intervention
No_intervention: standard of care
NO intervention, control group, receiving standard of care
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov