Infant Sleep Hygiene Counseling Trial

NCT02788630 | Completed

• 1 other identifier: 47/2014
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• Nighttime self-regulated sleep duration at 6, 12 and 24 months of age

  Nighttime self-regulated sleep duration is the maximum amount of time the child stays asleep or awake without awakening the parents at ages 6, 12 and 24 months. This outcome will be evaluated by using the actigraphy and diary records for 5 days. The Brief Infant Sleep Questionnaire (BISQ) will be used at these three visits.

  Up to 24 months

Secondary Outcomes (3)

• Linear growth between age 3-12 and 12-24 months of age

  Up to 24 months

• Neurocognitive development at 12 and 24 months of age.

  Up to 24 months

• Validation study of the Oxford neurodevelopment assessment tool (OX-NDA)

  Up to 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Arm: Experimental: Intervention group Field workers trained in sleep hygiene counseling will advice the mothers randomly allocated to the intervention group. The intervention will be delivered at the child household and will include information on: Normal sleep behaviors during the first year of life; ideal conditions to promote sleep onset like environmental improvements that ensure restful sleep (no screen media, low noise and light); calming naptime routines and avoiding stimulating or stressing children just before naptime; practices that promote child self-regulation of sleep, including putting infants to sleep drowsy but awake; and how to handle nighttime awakenings. A booklet with the intervention content to aid the mother in implementing the intervention will be used.

Behavioral: Sleep hygiene counseling

Control group

NO INTERVENTION

Mothers randomly allocated to the control group will be visited at home following the same schedule as the intervention group. The control group will receive a written material describing the advantages of breastfeeding over maternal and child health. No advice in relation to child sleep hygiene will be delivered to the mothers from the control group.

Interventions

Sleep hygiene counseling BEHAVIORAL

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.

Also known as: Child sleep trial

Intervention group

Eligibility Criteria

• Age: 3 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• To be eligible to the trial the child will need to belong to the Pelotas 2015 Birth Cohort, to be born healthy (newborns that needed intensive care after birth and with any congenital malformations will be excluded) from a single pregnancy at gestational age 37 weeks or greater, and to sleep regularly on average less than 13 hours per 24 hours (daytime and nighttime sleep) at three months of age (as reported by the mother). The information on child sleep duration per 24 hours will be gathered during the interview with mothers from the entire cohort, by means of the answer to the questions: "How many hours does the child sleep from 7pm to 7am?" and "How many hours does the child sleep from 7am to 7pm?"as well as number and duration of daytime naps, number of wake episodes during the night and how long it takes to the child to fall sleep after a nocturnal awakening.

You may not qualify if:

• Because the potential effect of the programmed maternal physical activity during pregnancy over the sleep duration or over the poor-sleeper-newborn answer to the sleep trial is not known, newborns to mothers that participated at the PAMELA trial will not be eligible to the sleep trial. The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) is a randomized controlled trial nested in the Pelotas 2015 birth cohort planned to assess the effect of regular exercise during pregnancy on the prevention of hypertension, pre-eclampsia and preterm birth. Eligible pregnant women between the 16th and 20th week of gestation are allocated into control group (426 women who are advised to keep their usual daily activities) or intervention group (213 women who engage in an exercise program, three sessions a week).
• Also, because the sleep intervention will recommend a series of environmental improvements to ensure a restful sleep (no screen media, low noise and light), the intervention will be restricted to families living in households with at least one bedroom. Children in continued use of medicines that can alter the sleep architecture and/or lead to drowsiness, like anticonvulsivants, will be excluded.

Sponsors & Collaborators

• Federal University of Pelotas: lead
• University of Toronto: collaborator
• University of Sao Paulo: collaborator
• Hospital Nossa Senhora da Conceicao: collaborator
• University of Oxford: collaborator

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96020220, Brazil

Location

Related Publications (2)

• Santos IS, Del-Ponte B, Tovo-Rodrigues L, Halal CS, Matijasevich A, Cruz S, Anselmi L, Silveira MF, Hallal PRC, Bassani DG. Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918062. doi: 10.1001/jamanetworkopen.2019.18062.

  PMID: 31860110 DERIVED

• Santos IS, Bassani DG, Matijasevich A, Halal CS, Del-Ponte B, da Cruz SH, Anselmi L, Albernaz E, Fernandes M, Tovo-Rodrigues L, Silveira MF, Hallal PC. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial. BMC Psychiatry. 2016 Sep 2;16(1):307. doi: 10.1186/s12888-016-1016-1.

  PMID: 27590170 DERIVED

Study Officials

• Bianca Del Ponte, PhD

  Federal University of Pelotas

  STUDY CHAIR

• Suélen Cruz, PhD

  Federal University of Pelotas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 2, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

BR (1)