Developmental Care for Congenital Heart Defects

Recruiting in Palo Alto (17 mi)

Overseen by Samantha Butler, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Children's Hospital

Disqualifiers: Cardiac arrest, CPR, ECMO, VAD, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment NIDCAP Developmental Care for congenital heart defects?

Research shows that the NIDCAP program, which involves personalized care for newborns, can reduce the need for ventilation and artificial feeding, shorten hospital stays, and improve brain development in premature babies. This suggests it might also help babies with congenital heart defects by providing similar developmental support.

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Is the NIDCAP developmental care program safe for humans?

The NIDCAP program, used in neonatal intensive care units, is generally considered safe and focuses on supporting the development of premature newborns by reducing the need for ventilation and artificial feeding, and shortening hospital stays.

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How is the NIDCAP treatment different from other treatments for congenital heart defects?

NIDCAP is unique because it focuses on providing a supportive environment tailored to each newborn's needs, involving family-centered care and behavioral observations to guide caregiving and environmental changes, which is different from traditional medical treatments that focus on medication or surgery.

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Eligibility Criteria

This trial is for newborns with complex congenital heart disease admitted to Boston Children's Hospital within 3 days of birth, needing open-heart surgery within two weeks. Eligible infants must be full-term, have no prior cardiac surgeries or severe associated anomalies, and not exposed to maternal substances. Mothers should be aged 20-45 years without known chromosomal abnormalities.

Inclusion Criteria

I am a mother aged between 20 and 45 years.

You are more than 37 weeks pregnant.

You do not have multiple birth defects or conditions like CHARGE syndrome.

Exclusion Criteria

I have had a cardiac arrest, CPR, ECMO, or VAD before joining this study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Infants receive Individualized Developmental Care (IDC) following the NIDCAP model in the Cardiac Intensive Care Unit (CICU) and Acute Cardiology Care Unit (ACCU).

up to 2 months

Continuous care during hospital stay

Follow-up

Participants are monitored for developmental outcomes and parent engagement after discharge.

3 months

Participant Groups

The study tests a developmental care intervention (IDC) designed to improve outcomes for hospitalized newborns with congenital heart disease by reducing stress and supporting development in the intensive care setting. It aims to show benefits such as shorter hospital stays, better feeding/growth, enhanced development, and improved parental coping.

Group I: Intervention Experimental Treatment 1 Intervention

NIDCAP developmental care group receiving intervention

Group II: standard of care Active Control 1 Intervention

NO intervention, control group, receiving standard of care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

Who Is Running the Clinical Trial?

Boston Children's Hospital Lead Sponsor

References

1. India pubmed.ncbi.nlm.nih.gov

Neonatal Intensive Care Unit Nurses' Perceptions and Knowledge of Newborn Individualized Developmental Care and Assessment Program: A Multicenter Study. [2022] The newborn individualized developmental care and assessment program (NIDCAP) is a new multifaceted approach, which is developmentally and functionally supportive of health especially in premature newborns at the neonatal intensive care unit (NICU). This study is designed for assessing the knowledge and perception of nurses as the most important members of the multidisciplinary team of NIDCAP about this program.

2. France pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized program of sustained development in neonatal intensive care: why, how?]. [2019] The Neonatal Individualized Developmental Care and Assessment Program (NIDCAP) is based upon a behavioral observation of the premature newborn. The information is used for suggesting individualized caregiving and environmental changes. The role of the parents in supporting the development is reinforced. This program appears to reduce ventilation, artificial feeding and hospitalization stay length, and is also found to improve neurobehavioral maturation. Its setting in a neonatal intensive care unit implies a collective reflective process and staff education.

3. United States pubmed.ncbi.nlm.nih.gov

Nurses' and Physicians' Experiences of the NIDCAP Model Implementation in Neonatal Intensive Care Units in Iran. [2019] The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) provides comprehensive newborn focused family-centered care in the Neonatal Intensive Care Unit (NICU). The purpose of this study was to investigate nurses' and physicians' experiences of implementing the NIDCAP model to optimize its implementation for both caregivers, infants, and families in the NICU.

4. Norway pubmed.ncbi.nlm.nih.gov

Individualized developmental care in a Dutch NICU: short-term clinical outcome. [2019] To compare the short-term clinical outcomes of Newborn Individualized Developmental Care and Assessment Program (NIDCAP) and conventional care.

5. Ireland pubmed.ncbi.nlm.nih.gov

Implementing NIDCAP training in a low-middle-income country: Comparing nurses and physicians' attitudes. [2021] The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) provides developmentally supportive environment for preterm infants and their families. Few studies evaluated staff perceptions about NIDCAP implementation and its effect on infant and parents and working conditions.

6. Ireland pubmed.ncbi.nlm.nih.gov

Support to mothers of premature babies using NIDCAP method: a non-randomized controlled trial. [2016] The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) is based on preterm infant's observation during hospitalization and considers infant's behavior as the key to evaluate the level of neurobehavioral maturation.

7. Norway pubmed.ncbi.nlm.nih.gov

Parental experiences during the first period at the neonatal unit after two developmental care interventions. [2018] Developmental care has gained increased attention in the individualized care for preterm infants. This study was designed to explore the effect of a basic form of developmental care and the more extended Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on parental stress, confidence and perceived nursing support.