[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578817":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":38,"studyPopulation":41,"armGroups":42,"interventions":51,"overallOfficials":68,"centralContacts":73,"locations":83,"responsibleParty":100,"collaborators":102,"id":114,"slug":38,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":38,"studyType":127,"phases":38,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":86,"whyStopped":38,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Universidade do Porto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":29},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Sleep patterns","Sleep patterns based on movement tracking by sleep actigraphy.","At 24 - 30 months of age, at 3 years of age and at 4 years of age",{"measure":14,"description":15,"timeFrame":12},"Psychomotor development","The psychomotor developmental coefficient obtained through the application of the evaluation tool Schedule of growing skills II (SGS II) development scale.",{"measure":17,"description":18,"timeFrame":12},"Sleep hygiene","Sleep hygiene data obtained through the application of the Children Sleep habits questionnaire validated for the Portuguese population.",{"measure":20,"description":21,"timeFrame":12},"Melatonin levels","Levels of 6-sulphatoxymelatonin-aMT6, melatonin metabolite, measured in urine.",[23,26],{"measure":24,"description":25,"timeFrame":12},"Body Mass Index [BMI]","Weight \\[kg, kilogram\\] and height \\[m, meter\\] at the date of the evaluation for BMI-for-age calculation",{"measure":27,"description":28,"timeFrame":12},"Number of infectious events","Number of infectious events in the first year of life and previous year of the following assessments.",[30,34],{"measure":31,"description":32,"timeFrame":33},"Demographics and lifestyle habits of the parents and family","Questionnaire about demographic parameters and lifestyle of the parents and family:\n\nAge 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.","At 24 - 30 months of age",{"measure":35,"description":36,"timeFrame":33},"Medical history and biometrics of the child","Questionnaire about the medical history and biometrics of the child:\n\nGestational 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.",{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":39,"timePerspective":40,"maskingInfo":38},null,"COHORT","PROSPECTIVE","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),",[43],{"label":44,"type":38,"description":45,"interventionNames":46},"Healthy children","Aged 2 to 4 years old",[47,48,49,50],"Other: Actigraphy","Other: Schedule of Growing Skills II","Other: Questionnaire Children Sleep habits","Other: Melatonin evaluation",[52,56,60,64],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":38},"Actigraphy","Actigraphy is a validated complementary means of diagnosis, the gold standard for the assessment of circadian rhythm.",[44],{"type":6,"name":57,"description":58,"armGroupLabels":59,"otherNames":38},"Schedule of Growing Skills II","Assessment scale for skills in child development from 0 to 6 years.",[44],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"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",[44],{"type":6,"name":65,"description":66,"armGroupLabels":67,"otherNames":38},"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.",[44],[69],{"name":70,"affiliation":71,"role":72},"Elisa Keating, PhD","faculty of medicine","PRINCIPAL_INVESTIGATOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":38,"email":78},"Andreia Neves, PhDc","CONTACT","(+351) 225513624","andreia.sobrinho.neves@gmail.com",{"name":80,"role":76,"phone":81,"phoneExt":38,"email":82},"Janete Santos, PhD","(+351) 225 513 600","investigaclinica@med.up.pt",[84],{"facility":85,"status":86,"city":87,"state":38,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Faculty of Medicine (FMUP)","RECRUITING","Porto","4200-319","Portugal","PT",{"type":92,"coordinates":93},"Point",[94,95],-8.61097,41.1485,{"lat":95,"lon":94},[98],{"name":70,"role":76,"phone":77,"phoneExt":38,"email":99},"keating@med.up.pt",{"type":101,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[103,105,107,109,112],{"name":104,"class":6},"Centro Hospitalar De São João, E.P.E.",{"name":106,"class":6},"Centro de Investigação em Tecnologias e Serviços de Saúde",{"name":108,"class":6},"Rede de Investigação em Saúde",{"name":110,"class":111},"Up2Kids Pediatric Center - Vila Nova de Gaia","UNKNOWN",{"name":113,"class":111},"USF Saúde no Futuro - Vila Nova de Gaia","100578817",false,"NCT06816225","Association Between Sleep and Psychomotor Development in Early Childhood","SleePsy","Inclusion Criteria:\n\n* Children aged 2 and 6 months year until the first assessment;\n* Gestational age at birth 37 weeks or more;\n* Delivery without serious complications for the child;\n* Absence of developmental pathologies or pathologies that interfere with psychic and motor development;\n\nExclusion Criteria:\n\n* Non-preterm birth but with severe growth restriction;\n* Diagnosis of psychomotor development pathology;\n* Diagnosis of pathology that interferes with psychomotor development;\n* Taking daily medication, except vitamin supplements.",true,"ALL","2 Years","4 Years",{"count":125,"type":126},119,"ESTIMATED","OBSERVATIONAL","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.\n\nGiven 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.",[130],"Sleep",[132,133,134,135],"childhood,","psychomotor development","melatonin","actigraphy","2025-02-03",{"date":138,"type":139},"2025-02-10","ACTUAL",{"date":141,"type":139},"2023-06-01",{"date":143,"type":126},"2025-12-01",{"name":5,"class":6},1]