Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

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.

Conditions

• Cardiology
• Infant Development
• Development Delay

Interventions

BEHAVIORAL

NIDCAP Developmental Care

The intervention of Individualized Developmental Care (IDC) is designed to minimize the mismatch between the fragile infant brain's expectations and the experiences of stress and pain inherent in the hospital environment. An ICU that provides individualized, developmentally-supportive care includes a soothing environment, supports parents as their child's primary caregiver, providing continual adjustment of caregiving in support of the child's wellbeing by reading the infant's cues and providing interventions to calmness throughout caregiving, capitalizing on the infant's strengths, and providing supports toward healing, growth and learning. NIDCAP is the experimental intervention to be tested in the current study. NIDCAP is the only evidence-based, comprehensive, internationally recognized program of IDC.

Sponsors & Collaborators

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Samantha Butler, PhD · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Max Age

4 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-10

Primary Completion

2025-05-01

Completion

2025-05-01

Countries

• United States

Study Locations