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NCT03447665 · ClinicalTrials.gov registry record · NA
Infant Behavioral Sleep Intervention: Comparative Efficacy
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03447665: Completed NA study, sponsored by Indiana University.
NCT03447665 is a NA study that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03447665, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental intervention throughout the night, are effective but often difficult for families to implement. The aim of this study is to compare the efficacy of two infant behavioral sleep interventions with a no treatment condition, on infant sleep and family functioning. Healthy infants between the ages of 6 and 18 months with night wakings will be randomized into one of three conditions: Entire night intervention, bedtime only intervention, or no treatment.
Primary Outcome
Total score on Infant Sleep Questionnaire (ISQ; range=0-38; higher score indicate more problematic sleep)
Interventions
- BEHAVIORAL Bedtime routine
- BEHAVIORAL Sleep schedule
- BEHAVIORAL Intervention (bedtime)
- BEHAVIORAL Intervention (after night wakings)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2019-04-10 |
| Phase | NA |
What the finished NCT03447665 record still lists
NCT03447665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Bedtime routine is the first listed.
NCT03447665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03447665 about?
NCT03447665 is a clinical study titled "Infant Behavioral Sleep Intervention: Comparative Efficacy". While frequent night awakenings in newborns are common and expected, an estimated 20-30% of older infants and toddlers have frequent problematic night wakings requiring parental intervention throughout the night. Standard infant behavioral sleep intervention approaches, which require parental interv...
What is the current status of trial NCT03447665?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2018-02-01. Estimated completion is 2019-04-10.
What interventions are being tested in trial NCT03447665?
The interventions under investigation include: Bedtime routine (BEHAVIORAL), Sleep schedule (BEHAVIORAL), Intervention (bedtime) (BEHAVIORAL), Intervention (after night wakings) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03447665?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03447665's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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