NCT02788630

Infant Sleep Hygiene Counseling Trial

Infant Sleep Hygiene Counseling: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: All
• Age: 3 Months – 4 Months
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention).

Detailed description

The development of adequate sleep patterns is paramount to the optimal neurodevelopment, as well as to promote proper learning, develop memory and preserve cerebral plasticity. Factors that hinder sleep patterns can negatively influence the child's growth, neurological and motor development. The investigators will conduct a randomized controlled trial within the 2015 Pelotas Birth Cohort. At the 3-month follow-up, children who sleep less than 13 hours per 24 hours (nighttime sleep and daytime naps) will be eligible for the study. The sample size was estimated at 276 children per arm. Nighttime self-regulated sleep duration will be evaluated at baseline (age 3 months) and at 6, 12 and 24 months using actigraphy and via a sleep diary completed by the mother. Following block randomization, mothers from the intervention group will be visited by a trained fieldworker who will deliver counseling on age-appropriate normal sleep behaviors, how to facilitate sleep onset and how to manage night awakenings.

Conditions

• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	Sleep hygiene counseling	The mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-06-02
• Last updated: 2016-06-15

Locations

1 site across 1 country: Brazil