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GPS (Giving Parents Support): Parent Navigation After NICU Discharge
NCT02643472 · View on ClinicalTrials.gov ↗
Study Summary
BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or amount beyond that required by children generally. NICU parents report increased anxiety and stress during their stay and transition home from the NICU. Short-term peer-to -peer programs during hospitalization decrease stress, anxiety and depression for mothers, however, no studies have evaluated the effects of long term post-discharge peer support. Children's National (CN) provides medical home services to CSHCN through its Parent Navigator Program (PNP). Parent Navigators (PNs) are CSHCN parents who provide peer emotional support, access to community resources, and assistance with navigating complicated health systems. NICU graduates and their caregivers may benefit from support provided by PNs after discharge. No data regarding the impact of PNs on patient and family outcomes of the NICU graduate are available. OBJECTIVE: To assess the impact of a PNP on a parent's self-efficacy, stress, anxiety, depression; infant health care utilization, and immunization status. METHODS: 300 NICU graduates will be randomized to receive either PN for 12 months (intervention group) or usual care (comparison group). Baseline data at 1 week, 1, 3, 6, and 12 months after discharge will be collected from caregivers in both groups including scales for self-efficacy, stress, anxiety, and depression, infant healthcare utilization and immunization status. Outcomes will be compared at 12 months. PATIENT OUTCOMES (PROJECTED) The study outcomes are parental self-efficacy, stress, anxiety, and depression; infant health care utilization and immunization status. ANTICIPATED IMPACT Prior studies utilizing small samples have suggested that peer support in the NICU can reduce anxiety and depression
Conditions Studied
Interventions
- BEHAVIORAL Parent Navigator
- BEHAVIORAL Care Notebook
Study Locations (1)
District of Columbia
- Children's National Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02643472
The ClinicalTrials.gov registry entry for NCT02643472 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's National Research Institute, which has 114 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Family appearing as the primary indexed condition, and to 2 interventions — of which Parent Navigator is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02643472 reports 1 study location spanning 1 distinct geographic area — top geographies include District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02643472 about?
NCT02643472 is a clinical study titled "GPS (Giving Parents Support): Parent Navigation After NICU Discharge". BACKGROUND: Annually \>400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge. Some NICU graduates can be classified as children with special health care needs (CSHCN) who will require health and related services of a type or a...
What is the current status of trial NCT02643472?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2016-01. Estimated completion is 2018-03.
What conditions does trial NCT02643472 study?
This clinical trial studies the following conditions: Family, Premature Birth of Newborn, Immature Newborn, Newborn Morbidity, Infant Newborn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02643472?
The interventions under investigation include: Parent Navigator (BEHAVIORAL), Care Notebook (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02643472?
This trial is sponsored by Children's National Research Institute, which has 114 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02643472 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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