What this study is
The goal of this clinical trial is to see if a Parent Navigator Program (PNP) is helpful for Latino/x parents of babies with congenital heart disease (CHD) to get connected to developmental follow-up services. The main question it aims to answer are:
- Do families assigned to the Parent Navigator Program (PNP) have higher rates of connection to High-Risk Infant Follow-Up (HRIF)/Early Intervention (EI) compared to the standard care group 6 months after randomization?
- Do children assigned to the Parent Navigator Program (PNP) have better neurodevelopmental outcomes (NDOs) compared to the standard care group 6 months after randomization?
- Do parents assigned to the Parent Navigator Program (PNP) have decreased parental stress compared to the standard care group?
Researchers will compare the Parent Navigator group to the standard care group to see if parent navigator group is helpful in connecting families to High-Risk Infant Follow-Up (HRIF)/Early Intervention (EI), improving neurodevelopmental outcomes (NDOs), and lowering parental stress.
Participants will:
- Undergo developmental assessments and survey at newborn stage and at 6 months
- Participants randomly assigned to the Parent Navigator group will have weekly (at least) phone calls with the parent navigator
- Participants randomly assigned to the Parent Navigator group will complete a 30-minute phone interview about their experience with the parent navigator program 6 months after random assignment
What's being tested
- Parent Navigator Program
Intervention · BEHAVIORAL
Participants in this group will be connected with a parent with lived experience to help get them obtain developmental follow up services and early intervention.
- Standard of Care
Intervention · BEHAVIORAL
The families in the standard care group will have their connections to neurodevelopmental (ND) follow-up and support delivered in the standard fashion which consists of a referral to high-risk infant follow-up (HRIF) by discharge coordinator.
Study details
- Sponsor
- Children's Hospital Los Angeles
- Conditions
- Congenital Heart Disease
- Enrolling
- 40 people
- Starts
- 2025-10-01
- Est. completion
- 2026-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Latino/x Infants:
- Infants born with CHD requiring medical/surgical intervention at less than 30 days of age
- Identify as Latino/x
- Identify as Latino/x
You can't join if
- Presence of a major genetic syndrome
- Intraventricular hemorrhage or other major structural brain lesion
- Undergoing end of life care Parents of Latino/x Infants:
- Not fluent in English or Spanish
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Hospital Los Angeles
Los Angeles, California, United States
- Emma Salmon, BS · Contact323-361-5103esalmon@chla.usc.edu
- Nhu Tran, PhD, RN · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Los Angeles
Study ID CHLA-25-00190
Principal investigator
Nhu Tran, PhD, RN
Children's Hospital Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.