Association Between Sleep and Psychomotor Development in Early Childhood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actigraphy, Schedule of Growing Skills II, Questionnaire Children Sleep habits, Melatonin evaluation.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: 2 years — 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Sleep is a neurophysiological active process essential for healthy physical and cognitive development. In Portugal, there is no recent and objective data on how children sleep. Given the importance of sleep in child health and development as well as the health gains achieved by establishing healthy sleep patterns since childhood, it seems extremely relevant to assess the various sleep parameters of Portuguese children and correlate them with their psychomotor and anthropometric development indicators. The results of this research work may support the implementation of sleep health education measures among parents, educators and policy makers, thus contributing to support the implementation of practices that promote sleep quality, napping until later in life as well as to promote the health of future adults.
Interventions
- Other Actigraphy
Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm. - Other Schedule of Growing Skills II
Assessment scale for skills in child development from 0 to 6 years. - Other Questionnaire Children Sleep habits
Questionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child - Other Melatonin evaluation
Melatonin will be measured in the first-morning urine and it is considered to be a good marker of plasma MLT level since its concentration is highly correlated with nocturnal plasma melatonin.
Primary outcome measures
- Sleep patterns [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
- Psychomotor development [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
- Sleep hygiene [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
- Melatonin levels [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
Secondary outcome measures (2)
- Body Mass Index [BMI] [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
- Number of infectious events [Time frame: At 24 - 30 months of age, at 3 years of age and at 4 years of age]
Eligibility criteria
Inclusion criteria
- Children aged 2 and 6 months year until the first assessment;
- Gestational age at birth 37 weeks or more;
- Delivery without serious complications for the child;
- Absence of developmental pathologies or pathologies that interfere with psychic and motor development;
Exclusion criteria
- Non-preterm birth but with severe growth restriction;
- Diagnosis of psychomotor development pathology;
- Diagnosis of pathology that interferes with psychomotor development;
- Taking daily medication, except vitamin supplements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Portugal · 1 center
- Faculty of Medicine (FMUP) — Porto
Identifiers
NCT: NCT06816225 · SleePsy