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NCT04592172 · ClinicalTrials.gov registry record · NA
Impact of Bedtime Routines on Sleep and Development in Toddlers
A NA study, sponsored by Saint Joseph's University, Philadelphia.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04592172: Completed NA study, sponsored by Saint Joseph's University, Philadelphia.
NCT04592172 is a NA study that has completed, run by Saint Joseph's University, Philadelphia. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04592172, a NA study, has completed, sponsored by Saint Joseph's University, Philadelphia.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, \& Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.
Primary Outcome
At the 12-month, 15-month, and 24-month visits, caregivers will report on bedtime routine frequency (the number of nights their child followed the same bedtime routine) from the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R).
Interventions
- BEHAVIORAL Bedtime Routine Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2022-11-04 |
| Phase | NA |
What the finished NCT04592172 record still lists
NCT04592172 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Bedtime Routine Education is the first listed.
NCT04592172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04592172 about?
NCT04592172 is a clinical study titled "Impact of Bedtime Routines on Sleep and Development in Toddlers". Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime ro...
What is the current status of trial NCT04592172?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2020-11-20. Estimated completion is 2022-11-04.
What interventions are being tested in trial NCT04592172?
The interventions under investigation include: Bedtime Routine Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT04592172?
This trial is sponsored by Saint Joseph's University, Philadelphia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04592172's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 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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