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Developmental Care for Congenital Heart Defects

N/A
Recruiting
Led By Samantha Butler, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mother's age greater than or equal to 20 and less than or equal to 45 years
Free from previous cardiac surgery or associated cardiovascular anomalies
Must not have
Patients who experience cardiac arrest, CPR, ECMO, or VAD prior to recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months of age
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if individualized developmental care helps improve medical and neurodevelopmental outcomes for infants with congenital heart disease, and increase parent well-being.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As IDC focuses on supportive environmental measures rather than medication or invasive procedures, significant side effects are not anticipated. However, the impact on individual infant stress levels and parent well-being will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a mother aged between 20 and 45 years.
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I have never had heart surgery or related heart problems.
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My newborn was admitted to the CICU at BCH within 3 days of birth.
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My newborn needs open heart surgery for a complex heart condition.
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I do not have genetic conditions like Down syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a cardiac arrest, CPR, ECMO, or VAD before joining this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NIDCAP Organizational Structures Assessment (OSA))
Secondary study objectives
Developmental Assessment of Young Children-Second Edition (DAYC-2)
Neonatal Network Neurobehavioral Scale II (NNNS) of Young Children-Second Edition (DAYC-2)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
NIDCAP developmental care group receiving intervention
Group II: standard of careActive Control1 Intervention
NO intervention, control group, receiving standard of care

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
785 Previous Clinical Trials
5,581,701 Total Patients Enrolled
Samantha Butler, PhDPrincipal InvestigatorBoston Children's Hospital

Media Library

NIDCAP Developmental Care Clinical Trial Eligibility Overview. Trial Name: NCT05885113 — N/A
Cardiology Research Study Groups: Intervention, standard of care
Cardiology Clinical Trial 2023: NIDCAP Developmental Care Highlights & Side Effects. Trial Name: NCT05885113 — N/A
NIDCAP Developmental Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05885113 — N/A
~8 spots leftby May 2025
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