Infant Sleep Hygiene Counseling Trial

NACompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Sleep
Interventions
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.

Trial Locations (1)

96020220

Federal University of Pelotas, Pelotas

All Listed Sponsors
collaborator

University of Toronto

OTHER

collaborator

University of Sao Paulo

OTHER

collaborator

Hospital Nossa Senhora da Conceicao

OTHER

collaborator

University of Oxford

OTHER

lead

Federal University of Pelotas

OTHER

NCT02788630 - Infant Sleep Hygiene Counseling Trial | Biotech Hunter | Biotech Hunter