Infant Sleep Hygiene Counseling Trial
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|ClinicalTrials.gov Identifier: NCT02788630|
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : June 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Behavioral: Sleep hygiene counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||552 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Infant Sleep Hygiene Counseling: A Randomized Controlled Trial|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Intervention group
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
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.
Other Name: Child sleep trial
No Intervention: Control group
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.
- Nighttime self-regulated sleep duration at 6, 12 and 24 months of age [ Time Frame: Up to 24 months ]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.
- Linear growth between age 3-12 and 12-24 months of age [ Time Frame: Up to 24 months ]The effect of the intervention on linear growth will be estimated by comparing conditional growth between groups. At 3, 12 and 24 months of age anthropometric evaluation will include measures of length and weight. Length will be measured using a foldable wooden infantometer, custom made for the study, using for measurement a nylon tape measure with 1 mm precision adhered to a groove carved into the body of the instrument. Mother and child weight will be measured using an electronic scale (150 kg capacity and 100 g precision), the mother being weighed first alone then holding the baby. The child's weight will be calculated as the difference between the two measures. The mother will be weighed clothed, but without heavy outfits, and clothes worn by the mother will be recorded. The child will be weighed undressed, whenever allowed by the mother. Otherwise, the child's clothing will be recorded.
- Neurocognitive development at 12 and 24 months of age. [ Time Frame: Up to 24 months ]The holistic neurodevelopment assessment designed and implemented by the Intergrowth-21st Project (Intergrowth neurodevelopment assessment tool - INTER-NDA) will be used to measure cognitive, motor, language, behavioral, attention, and executive function outcomes in children at 24 months. The recently developed 12-month version of the instrument (Oxford neurodevelopment assessment tool - OX-NDA) will be used to assess the child neurodevelopment at 12 months of age.
- Validation study of the Oxford neurodevelopment assessment tool (OX-NDA) [ Time Frame: Up to 12 months ]100 children aged 10-12 months from the 2015 Pelotas Birth Cohort will participate in a validation study in which the OX-NDA results will be compared to the results of the Bayley Scales of Infant and Toddler Development - Third Edition (BSDI-III) taken as the gold standard.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788630
|Federal University of Pelotas|
|Pelotas, RS, Brazil, 96020220|
|Study Chair:||Bianca Del Ponte, PhD||Federal University of Pelotas|
|Study Chair:||Suélen Cruz, PhD||Federal University of Pelotas|