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

30 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 5 7}

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.

Research Team

Samantha Butler, PhD

Principal Investigator

Boston Children's Hospital

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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

[Implementation of an individualized program of sustained development in neonatal intensive care: why, how?]. [2019]

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]

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

Individualized developmental care in a Dutch NICU: short-term clinical outcome. [2019]

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

Implementing NIDCAP training in a low-middle-income country: Comparing nurses and physicians' attitudes. [2021]

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

Support to mothers of premature babies using NIDCAP method: a non-randomized controlled trial. [2016]

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

Parental experiences during the first period at the neonatal unit after two developmental care interventions. [2018]