Trial reportBMC psychiatry2016
Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.
Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Infant Sleep Hygiene Counseling: A Randomized Controlled Trial
The 2015 Pelotas (Brazil) Birth Cohort Study
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Interventions for preventing obesity in children.The Cochrane database of systematic reviews · 2019Pooled it
- Effect of Parental Counseling on Infants' Healthy Sleep Habits in Brazil: A Randomized Clinical Trial.JAMA network open · 2019Trial
- Evaluating Educational Patterns and Methods in Infant Sleep Care: Trends, Effectiveness, and Impact in Home Settings-A Systematic Review.Children (Basel, Switzerland) · 2024Review
- Sleep initiation patterns and sleep quality among toddlers in the southeast of China: initial study results.BMC pediatrics · 2024Article
- Cohort Profile Update: 2015 Pelotas (Brazil) Birth Cohort Study－follow-ups from 2 to 6-7 years, with COVID-19 impact assessment.International journal of epidemiology · 2024Article
- Article
- Reliability, validity, and psychometric properties of the Persian version of the Tayside children's sleep questionnaire.Sleep and biological rhythms · 2023Article
- Construction and validation of the Oxford Neurodevelopment Assessment (OX-NDA) in 1-year-old Brazilian children.BMC pediatrics · 2022Article
- The First United Arab Emirates National Representative Birth Cohort Study: Study Protocol.Frontiers in pediatrics · 2022Article
- Parental attendance in two early-childhood training programmes to improve nurturing care: A randomized controlled trial.Children and youth services review · 2020Article
- Cohort Profile: The 2015 Pelotas (Brazil) Birth Cohort Study.International journal of epidemiology · 2018Article
- Sleep patterns, problems, and habits in a sample of Egyptian preschoolers.Sleep science (Sao Paulo, Brazil)Article
- A WhatsApp-Based Intervention to Improve Maternal Social Support and Maternal-Child Health in Southern Brazil: The Text-Message Intervention to Enhance Social Support (TIES) Feasibility Study.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.
methodsThe study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months. DISCUSSION: The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.
trial registrationClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.