About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial population
The study population will be healthy children aged 2 to 4 years old. Considering that the most prevalent differences in Growing Skills II scale scores will be around 3 and 5 points for a healthy toddler population as ours and that we will need to divide the population into 3 groups of sleep patterns (seriously sleep-restricted, moderately sleep-restricted and normal sleepers),
Trial design
Cohort
Prospective
Treatments tested in this trial
Actigraphy
Other interventionActigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.
Schedule of Growing Skills II
Other interventionAssessment scale for skills in child development from 0 to 6 years.
Questionnaire Children Sleep habits
Other interventionQuestionnaire for assessing sleep habits, validated for the Portuguese population (4) which allows us to understand the sleep hygiene habits of the child
Melatonin evaluation
Other interventionMelatonin 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.
Treatment groups
Trial outcomes
Primary outcomes
Sleep patterns
Sleep patterns based on movement tracking by sleep actigraphy.
Psychomotor development
The psychomotor developmental coefficient obtained through the application of the evaluation tool Schedule of growing skills II (SGS II) development scale.
Sleep hygiene
Sleep hygiene data obtained through the application of the Children Sleep habits questionnaire validated for the Portuguese population.
Melatonin levels
Levels of 6-sulphatoxymelatonin-aMT6, melatonin metabolite, measured in urine.
Secondary outcomes
Body Mass Index [BMI]
Weight \[kg, kilogram\] and height \[m, meter\] at the date of the evaluation for BMI-for-age calculation
Number of infectious events
Number of infectious events in the first year of life and previous year of the following assessments.
Other outcomes
Demographics and lifestyle habits of the parents and family
Questionnaire about demographic parameters and lifestyle of the parents and family: Age group (less than 24 years; 24-29; 30-35; 35-40; more than 40); Household; Level of education; Profession; Shift work; Smoking habits; Diet (omnivore, vegetarian, ovolactovegetarian, vegan or other); Average bedtime; Average total sleeping time; Sleep schedules between weekdays and the weekend; Chronotype; History of sleep disturbances; Vitamin supplementation during pregnancy; History of postpartum depression.
Medical history and biometrics of the child
Questionnaire about the medical history and biometrics of the child: Gestational age at birth; APGAR index; Weight \[kg, kilogram\], length \[meter, m\] and head circumference \[centimeter, cm\] at birth; Type of feeding (breast milk, adapted milk or mixed feeding); Daycare attendance.
Sponsors and contacts
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Universidade do Porto
Lead sponsor
Centro Hospitalar De São João, E.P.E.
Collaborator
Centro de Investigação em Tecnologias e Serviços de Saúde
Collaborator
Rede de Investigação em Saúde
Collaborator
Up2Kids Pediatric Center - Vila Nova de Gaia
Collaborator
USF Saúde no Futuro - Vila Nova de Gaia
Collaborator