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NCT05488379 · ClinicalTrials.gov registry record · NA
Child Healthcare at MATER - Pediatric Study
A NA study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
NCT05488379: Completed NA study, sponsored by Thomas Jefferson University.
NCT05488379 is a NA study that has completed, run by Thomas Jefferson University. The registered enrollment target is 49 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05488379, a NA study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
Study Summary
The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.
Primary Outcome
Measured as both utilization and experience of well child care. Utilization will be defined as total number of well child care visits during the child's first 18 months of life. Adequacy of well child care during this time period will be dichotomized as adequate (7 well child care visits) or inadequate (\<7 well child care visits). This definition is adapted from the Health Plan Employer Data and Information Set (HEDIS) measure for well child care. The Promoting Healthy Development Survey (PHDS)
Interventions
- OTHER Group well child care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-12-31 |
| Est. Completion | 2026-01-29 |
| Phase | NA |
What the finished NCT05488379 record still lists
NCT05488379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Group well child care is the first listed.
NCT05488379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05488379 about?
NCT05488379 is a clinical study titled "Child Healthcare at MATER - Pediatric Study". The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioi...
What is the current status of trial NCT05488379?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2021-12-31. Estimated completion is 2026-01-29.
What interventions are being tested in trial NCT05488379?
The interventions under investigation include: Group well child care (OTHER).
Who is sponsoring clinical trial NCT05488379?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05488379's enrollment target sits among peer trials
49 1379th of 2000 higher than 620 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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