Infant Night Wakings in Pediatric Primary Care

Completed · Not applicable

Conditions studied: Insomnia, Night Wakings

In brief

This study aims to: 1. identify which single item or combination of two items perform best in identifying problematic infant night wakings and 2. describe current practices by pediatricians in addressing problematic infant night wakings. Using a novel computer decision support system in several primary care clinics, caregivers accompanying their child to a health visit will be randomly assigned to receive two of five items assessing night wakings and/or sleep problems, followed by a validated questionnaire for infant night wakings. If caregiver responses to the items suggest a possible sleep problem, pediatricians will receive a prompt in the electronic health record identifying a possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding the content of the visit that day.

Key facts

Study ID

NCT02780596

Run by

Indiana University

People needed

3501

Starts

2016-02-01

Expected to finish

2017-11-01

Last updated by the study team

2018-02-22

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant between the ages of 5 and 20 months (at the time of the visit)
• Caregiver responds to questions on the prescreening form in the waiting room
• Infant is a patient at one of five participating primary care health clinics in Indianapolis Indiana.
• For participation in the phone interviews, caregiver speaks English.

You may not qualify if…

• None

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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