Infant Behavioral Sleep Intervention: Comparative Efficacy
Public ClinicalTrials.gov record NCT03447665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Infant Behavioral Sleep Intervention: Comparative Efficacy Across Two Approaches "The Sleeping Baby Study"
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03447665
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- Bedtime routine Behavioral
- Sleep schedule Behavioral
- Intervention (bedtime) Behavioral
- Intervention (after night wakings) Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 6 Months to 18 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2018
- Primary completion
- Apr 9, 2019
- Completion
- Apr 9, 2019
- Last update posted
- Apr 17, 2019
2018 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03447665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03447665 live on ClinicalTrials.gov.