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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months of age

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months of age

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NIDCAP Organizational Structures Assessment (OSA))

Secondary outcome measures

Developmental Assessment of Young Children-Second Edition (DAYC-2)

Neonatal Network Neurobehavioral Scale II (NNNS) of Young Children-Second Edition (DAYC-2)

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,900 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still the opportunity to participate in this research endeavor?

"Contrary to what is recorded on clinicaltrials.gov, this trial has ceased recruiting patients since the last update on May 22nd 2023. Nevertheless, there are currently 402 other studies that require participants’ involvement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

Samantha Butler 2023. "Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05885113.

All > Heart Disease