Parent Navigator Program to help Latino/x families of babies with congenital heart disease connect to developmental services
Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents
This trial will test whether a Parent Navigator Program helps Latino/x parents of newborns with congenital heart disease connect to follow-up and early intervention services, improve child neurodevelopment, and reduce parental stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07023367 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial at Children's Hospital Los Angeles compares a Parent Navigator Program (PNP) to standard care for Latino/x infants with congenital heart disease and their parents. Enrolled infants must have required medical or surgical intervention within 30 days of birth, and families must identify as Latino/x with parents fluent in English or Spanish. The main outcomes measured at six months after randomization are connection to High-Risk Infant Follow-Up (HRIF)/Early Intervention (EI), neurodevelopmental outcomes in the child, and parental stress. Participants with major genetic syndromes, major brain lesions, or receiving end-of-life care are excluded.
Who should consider this trial
Good fit: Ideal candidates are Latino/x infants born with congenital heart disease who required medical or surgical intervention within 30 days of life and their parents who are fluent in English or Spanish and not facing major genetic syndromes, major brain lesions, or end-of-life care.
Not a fit: Patients unlikely to benefit include those with major genetic syndromes, significant brain injuries, infants in end-of-life care, non-Latino/x families, or parents not fluent in English or Spanish.
Why it matters
Potential benefit: If successful, the program could increase timely enrollment in HRIF/EI, improve early neurodevelopmental outcomes, and reduce parental stress for Latino/x families of infants with CHD.
How similar studies have performed: Previous care-navigation and community health worker programs have improved linkage to early intervention in other pediatric populations, but randomized data specifically in Latino/x infants with CHD are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Latino/x Infants: Inclusion Criteria: * Infants born with CHD requiring medical/surgical intervention at less than 30 days of age * Identify as Latino/x Exclusion Criteria: * Presence of a major genetic syndrome * Intraventricular hemorrhage or other major structural brain lesion * Undergoing end of life care Parents of Latino/x Infants: Inclusion Criteria: * Identify as Latino/x Exclusion Criteria: * Not fluent in English or Spanish
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Nhu Tran, PhD, RN — Children's Hospital Los Angeles
- Study coordinator: Emma Salmon, BS
- Email: esalmon@chla.usc.edu
- Phone: 323-361-5103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.