Clinical trial NCT06816225: Association Between Sleep and Psychomotor Development in Early Childhood
Official title: Association Between Sleep and Psychomotor Development in Early Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep
Keywords: childhood,
psychomotor development
melatonin
actigraphy
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar De São João, E.P.E.
name: Centro de Investigação em Tecnologias e Serviços de Saúde
name: Rede de Investigação em Saúde
name: Up2Kids Pediatric Center - Vila Nova de Gaia
name: USF Saúde no Futuro - Vila Nova de Gaia
First posted: 2025-02-10
Enrollment: 119
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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),

Brief summary: 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: 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.

Primary outcomes:
measure: Sleep patterns
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
measure: Psychomotor development
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
measure: Sleep hygiene
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
measure: Melatonin levels
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Secondary outcomes:
measure: Body Mass Index [BMI]
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
measure: Number of infectious events
timeFrame: At 24 - 30 months of age, at 3 years of age and at 4 years of age
Other outcomes:
measure: Demographics and lifestyle habits of the parents and family
timeFrame: At 24 - 30 months of age
measure: Medical history and biometrics of the child
timeFrame: At 24 - 30 months of age
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine (FMUP)
Study officials:
affiliation: faculty of medicine
name: Elisa Keating, PhD
role: PRINCIPAL_INVESTIGATOR
References: