Nctid:
NCT06232811
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012678", "term"=>"Sensation Disorders"}], "ancestors"=>[{"id"=>"D009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M25869", "name"=>"Premature Birth", "relevance"=>"LOW"}, {"id"=>"M15490", "name"=>"Sensation Disorders", "asFound"=>"Sensory Disorders", "relevance"=>"HIGH"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>42}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-21", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-11-21", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mother-to-Infant Bonding Scale", "timeFrame"=>"15 minutes", "description"=>"The Mother-to-Infant Bonding Scale is a tool designed for evaluating mother-infant bonding. Comprising 10 items on a 4-point scale, this scale yields a total score ranging from 0 to 30. Higher scores on the scale are indicative of poorer mother-to-infant bonding."}, {"measure"=>"Test of Sensory Functions in Infants", "timeFrame"=>"30 minutes", "description"=>"The test consists of 24 items divided into five subtests: sensory processing and reactivity. subtests include: deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and vestibular stimulation. By observing the baby's response, items are scored from negative to normal according to the criteria provided; Items are given 0, 1 or 2 points depending on the baby's reaction."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Preterm", "Sensory Disorder", "Attachment Disorder"]}, "descriptionModule"=>{"briefSummary"=>"Establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future. This research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.", "detailedDescription"=>"At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to evaluate the bonding between themselves and their infants. Subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the Test of Sensory Functions in Infants (TSFI). The study will encompass both preterm and term-born children."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 months", "minimumAge"=>"12 months", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Preterm and term children aged 12 months", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\npreterm children with a gestational age \\<34 weeks Term children with a gestational age between 37 and 41 weeks\n\nExclusion Criteria:\n\n* infants with chromosomal defects, metabolic or neuromuscular disease,\n* hydrocephalus, cerebral palsy, congenital heart disease,"}, "identificationModule"=>{"nctId"=>"NCT06232811", "briefTitle"=>"Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age", "organization"=>{"class"=>"OTHER", "fullName"=>"Gazi University"}, "officialTitle"=>"Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age", "orgStudyIdInfo"=>{"id"=>"E-77082166-604.01.02-639350"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Preterm", "description"=>"preterm infants with gestational age \\<34 weeks", "interventionNames"=>["Behavioral: Assessment"]}, {"label"=>"Term", "description"=>"term infants with gestational age \\>37 weeks", "interventionNames"=>["Behavioral: Assessment"]}], "interventions"=>[{"name"=>"Assessment", "type"=>"BEHAVIORAL", "description"=>"Sensory processing skills of children in the preterm and term groups will be evaluated. Additionally, the attachment between mother and baby will be evaluated.", "armGroupLabels"=>["Preterm", "Term"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Erzurum", "country"=>"Turkey", "facility"=>"Erzurum Technical University", "geoPoint"=>{"lat"=>39.90861, "lon"=>41.27694}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gazi University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Gazi University", "investigatorFullName"=>"Ayse Simsek", "investigatorAffiliation"=>"Gazi University"}}}}
