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Infant Night Wakings in Pediatric Primary Care

NCT02780596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3501

Last updated 2018-02-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Item1

Does CHILD NAME often wake one or more times during the night?

OTHER

Item2

Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?

OTHER

Item3

Do you think CHILD'S SLEEP is a problem?

OTHER

Item4

Do you think CHILD NAME has a sleep problem?

OTHER

Item5

Do you have any concerns about CHILD NAME'S sleep?

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Sarah M Honaker, PhD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
20 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780596 on ClinicalTrials.gov