Developmental Care for Congenital Heart Defects

Overseen By Katrina Severtson, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to care for newborns with congenital heart defects (CHD) to determine if it can improve their development and health outcomes. The focus is on using individualized developmental care (IDC) in the hospital to reduce stress from treatments and help both infants and their parents cope better. In this trial, one group of infants will receive this special care, known as NIDCAP Developmental Care, while another group will receive standard hospital care. Good candidates for this study are newborns at Boston Children's Hospital with complex CHD requiring early heart surgery, who are free from other major health issues and have access to a phone or the internet. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies for newborns with CHD.

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 prior data suggests that this developmental care intervention is safe for infants with congenital heart disease?

Research has shown that the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) is safe and well-tolerated. Studies indicate that NIDCAP improves outcomes for premature babies by supporting brain development, enhancing thinking skills, and improving behavior without causing harm. These findings suggest that NIDCAP is safe for infants.

In this trial, researchers are testing NIDCAP for babies with congenital heart defects. Although this application is new for these patients, the positive safety record in other infant groups is encouraging. NIDCAP aims to reduce stress and create a calming hospital environment. This approach is designed to support healthy development, making it a low-risk option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NIDCAP developmental care for congenital heart defects because it offers a unique approach to supporting infants with these conditions. Unlike standard medical treatments that focus primarily on surgical or pharmaceutical interventions, NIDCAP emphasizes individualized care tailored to each infant's developmental needs. This approach aims to create a nurturing environment that supports brain development and enhances long-term outcomes. By focusing on personalized, sensitive care, NIDCAP could potentially improve cognitive and emotional development in ways that traditional medical treatments do not address.

What evidence suggests that this developmental care is effective for congenital heart defects?

Research shows that the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) can greatly help babies in intensive care. Studies have found that babies receiving NIDCAP often experience better health outcomes, such as reduced time on breathing machines and easier weight gain. Evidence also suggests these babies may spend less time in the hospital. While most research has focused on premature babies, the positive results indicate potential benefits for babies with congenital heart defects (CHD) as well. In this trial, some participants will receive NIDCAP developmental care, while others will receive standard care. By reducing stress and supporting growth, NIDCAP may improve both the health and development of these babies over time. ^{1 3 6 7 8}

Who Is on the Research Team?

Samantha Butler, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• NIDCAP Developmental Care

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

The Neonatal Individualized Developmental Care and Assessment Program (NIDCAP) helps improve the care of premature newborns by using behavioral observations to tailor caregiving and environmental conditions, which supports their development.

Implementing NIDCAP in neonatal intensive care units has been associated with reduced need for ventilation and artificial feeding, shorter hospital stays, and enhanced neurobehavioral maturation in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized program of sustained development in neonatal intensive care: why, how?]. Sizun, J., Ratynski, N., Mambrini, C.[2019]

In a study comparing Newborn Individualized Developmental Care and Assessment Program (NIDCAP) to conventional care in a NICU, NIDCAP infants had a significantly lower risk of severe cerebral damage, with an odds ratio of 0.12, suggesting potential neuroprotective benefits despite other clinical outcomes being similar.

However, NIDCAP infants experienced a higher incidence of pneumonia due to nosocomial infections (9 vs. 3), indicating a need for careful monitoring and further research to balance the benefits and risks of this care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized developmental care in a Dutch NICU: short-term clinical outcome. Wielenga, JM., Smit, BJ., Merkus, MP., et al.[2019]

The implementation of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) was positively perceived by NICU staff, with nurses reporting significantly higher satisfaction and perceived benefits compared to doctors, indicating a strong acceptance of the program among healthcare providers.

Staff believed that NIDCAP improved infant care and well-being, as well as enhanced relationships with parents, although they noted that working conditions still posed challenges, highlighting areas for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing NIDCAP training in a low-middle-income country: Comparing nurses and physicians' attitudes. Charafeddine, L., Masri, S., Sharafeddin, SF., et al.[2021]

A study involving 120 nurses in NICUs found that they had a high level of knowledge (average score of 71.83) and perception (average score of 76.80) regarding the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), which supports the health of premature newborns.

Factors such as marital status, having an MSc degree, and years of experience significantly influenced nurses' knowledge about NIDCAP, indicating that education and experience play a role in understanding this developmental care approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal Intensive Care Unit Nurses' Perceptions and Knowledge of Newborn Individualized Developmental Care and Assessment Program: A Multicenter Study. Baghlani, R., Hosseini, MB., Safaiyan, A., et al.[2022]

The study compared the effects of basic developmental care and the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on parental stress and confidence in parents of preterm infants, involving 283 participants across two randomized controlled trials.

Overall, neither form of developmental care significantly improved parental confidence, perceived nursing support, or stress levels, but NIDCAP appeared to reduce the stress gap between mothers and fathers, likely due to increased paternal involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental experiences during the first period at the neonatal unit after two developmental care interventions. van der Pal, SM., Maguire, CM., le Cessie, S., et al.[2018]

The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) significantly improved mothers' support scores compared to Standard Care, indicating better involvement in their infants' care.

Infants who received NIDCAP showed a higher percentage of normal neurofunctional development at term, suggesting that this program may enhance short-term developmental outcomes for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support to mothers of premature babies using NIDCAP method: a non-randomized controlled trial. Sannino, P., Giannì, ML., De Bon, G., et al.[2016]

The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) is an effective care model for premature infants that promotes their growth and development while also enhancing caregivers' self-efficacy, as highlighted by qualitative interviews with 11 nurses and 4 physicians.

Successful implementation of NIDCAP requires consideration of the social context and available resources in each country, emphasizing the need for proper support and infrastructure to sustain NIDCAP specialists in NICU units globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurses' and Physicians' Experiences of the NIDCAP Model Implementation in Neonatal Intensive Care Units in Iran. Mirlashari, J., Fomani, FK., Brown, H., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4248304/

Comprehensive Care for Preterm Infants - PubMed Central - NIH The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) aims to prevent the iatrogenic sequelae of intensive care and to maintain the ...

2. publications.aap.org publications.aap.org/neoreviews/article/6/3/e115/89486/Newborn-Individualized-Developmental-Care-and

Newborn Individualized Developmental Care and ... The mortality among infants born preterm has decreased dramatically during the last decade in developed countries.

3. childrenshospital.org childrenshospital.org/clinical-trials/nct05885113

NCT05885113 The proposed study includes a newborn developmental intervention to improve neurodevelopmental (ND) and medical outcomes for infants with congenital heart ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/apa.17300

The newborn individualised developmental care and ... Evidence shows NIDCAP significantly improves medical outcomes, with less time on the ventilator, improved weight gain, decreased length of stay, ...

5. nidcap.org nidcap.org/wp-content/uploads/2023/11/Program-Guide-Rev-8Nov2023.pdf

Program Guide Newborn Individualized Developmental ... Newborn Individualized Developmental Care and Assessment Program (NIDCAP). An Education and Training Program for Health Care Professionals.

6. nidcap.org nidcap.org/individualized-developmental-care-to-improve-the-lives-of-children-with-congenital-heart-disease/

Individualized Developmental Care to Improve the Lives of ... Despite the research and publications on the positive outcomes for NIDCAP and the increasing availability of NIDCAP training, it is not ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9973655/

Developmental Care for Hospitalized Infants With Complex ... Developmental disorders, disabilities, and delays are a common outcome for individuals with complex congenital heart disease, yet targeting early factors ...

8. nidcap.org nidcap.org/wp-content/uploads/2020/09/Nidcap_vol_11_no1-Final.pdf

Developmental Observer The purpose of this project is to disseminate the most current developmental practices to rehabilitation professionals working in the critical care environ-.