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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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03447665
The ClinicalTrials.gov registry entry for NCT03447665 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bedtime routine is the first listed.
NCT03447665 reports 0 study locations.
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.
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