Association Between Sleep and Psychomotor Development in Early Childhood

ConditionSleep
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-4
SponsorUniversidade do Porto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Actigraphy

    Other intervention

    Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.

  • Schedule of Growing Skills II

    Other intervention

    Assessment scale for skills in child development from 0 to 6 years.

  • Questionnaire Children Sleep habits

    Other intervention

    Questionnaire 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 intervention

    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.

Treatment groups

119 Participants
are divided into 1 treatment group
Group A: Healthy children4 interventions

Trial outcomes

Primary outcomes

1

Sleep patterns

Sleep patterns based on movement tracking by sleep actigraphy.

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age
2

Psychomotor development

The psychomotor developmental coefficient obtained through the application of the evaluation tool Schedule of growing skills II (SGS II) development scale.

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age
3

Sleep hygiene

Sleep hygiene data obtained through the application of the Children Sleep habits questionnaire validated for the Portuguese population.

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age
4

Melatonin levels

Levels of 6-sulphatoxymelatonin-aMT6, melatonin metabolite, measured in urine.

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age

Secondary outcomes

1

Body Mass Index [BMI]

Weight \[kg, kilogram\] and height \[m, meter\] at the date of the evaluation for BMI-for-age calculation

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age
2

Number of infectious events

Number of infectious events in the first year of life and previous year of the following assessments.

Time frame
At 24 - 30 months of age, at 3 years of age and at 4 years of age

Other outcomes

1

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.

Time frame
At 24 - 30 months of age
2

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.

Time frame
At 24 - 30 months of age

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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