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NCT02643472 · ClinicalTrials.gov registry record · NA
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
A NA study of Family and Premature Birth of Newborn, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT02643472 is a NA study of Family and Premature Birth of Newborn that has completed, run by Children's National Research Institute. The registered enrollment target is 300 participants, above the 157-participant average among 9 other Family trials with a reported enrollment target (91% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02643472, a NA study of Family and Premature Birth of Newborn, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 157-participant average among 9 other Family trials with a reported enrollment target (91% higher). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.
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.
NCT02643472 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
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.
What interventions are being tested in trial NCT02643472?
The interventions under investigation include: Parent Navigator (BEHAVIORAL), Care Notebook (BEHAVIORAL).
Who is sponsoring clinical trial NCT02643472?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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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