Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:34 AM
Study NCT ID:
NCT07343505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-15
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Environmental Enrichment Intervention and Brain Development in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be prospectively assigned to one of two parallel groups using stratified assignment based on gestational age. One group will receive standard care alone, while the other group will receive a structured environmental enrichment-based HEP home intervention in addition to standard care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Motor development will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), Motor Composite Score, which evaluates fine and gross motor development.\n\nThe Motor Composite Score ranges from 40 to 160, with higher scores indicating better motor development.'}, {'measure': 'Motor Performance Assessed by Test of Infant Motor Performance (TIMP)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Motor performance will be assessed using the Test of Infant Motor Performance (TIMP), which evaluates postural and selective control of movement in young infants.\n\nThe TIMP total score ranges from -49 to 142, with higher scores indicating better motor performance.'}], 'secondaryOutcomes': [{'measure': 'Cognitive Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Cognitive development will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), Cognitive Composite Score, which evaluates cognitive abilities including attention, memory, and problem-solving.\n\nThe Cognitive Composite Score ranges from 40 to 160, with higher scores indicating better cognitive development.'}, {'measure': 'Brain Morphometric Measurements Assessed by Cranial Ultrasound Imaging', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Brain structural development will be evaluated using cranial ultrasound imaging with morphometric measurements, including ventricular size and selected linear brain dimensions.\n\nChanges in morphometric measurements over time will be used to assess brain structural development, with larger or more age-appropriate measurements indicating more advanced brain development.'}, {'measure': 'Urinary Concentration of Brain-Derived Neurotrophic Factor (BDNF)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Urine samples will be collected to measure the concentration of brain-derived neurotrophic factor (BDNF) using standardized immunoassay methods.\n\nBDNF levels will be reported as urinary concentration, and changes in concentration over time will be used to evaluate neurodevelopmental effects of the intervention.\n\nHigher BDNF levels indicate enhanced neurotrophic support.'}, {'measure': 'Urinary Concentration of Nerve Growth Factor (NGF)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Urine samples will be collected to measure the concentration of nerve growth factor (NGF) using standardized immunoassay methods.\n\nNGF levels will be reported as urinary concentration, and changes in concentration over time will be used to assess neurodevelopmental support.\n\nHigher NGF levels indicate enhanced neurodevelopmental processes.'}, {'measure': 'Urinary Concentration of Tau Protein', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Urine samples will be collected to measure the concentration of Tau protein using standardized immunoassay methods.\n\nTau levels will be reported as urinary concentration, and changes in concentration over time will be interpreted in relation to neuronal integrity.\n\nAlterations in Tau concentration may reflect changes in neuronal structure or injury.'}, {'measure': 'Urinary Concentration of S100 Calcium-Binding Protein B (S100B)', 'timeFrame': 'Baseline (corrected age of 1 month) and 12 weeks (end of intervention)', 'description': 'Urine samples will be collected to measure the concentration of S100 calcium-binding protein B (S100B) using standardized immunoassay methods.\n\nS100B levels will be reported as urinary concentration, and changes in concentration over time will be used to evaluate brain structural integrity.\n\nElevated S100B levels are interpreted in relation to brain tissue stress or injury.'}, {'measure': 'Depression, Anxiety, and Stress Scale-21 Items (DASS-21) Total and Subscale Scores in Caregivers', 'timeFrame': 'Baseline and 12 weeks (post-intervention)', 'description': 'Caregiver psychological status will be assessed using the Depression, Anxiety, and Stress Scale-21 Items (DASS-21), a self-report questionnaire consisting of three subscales: depression, anxiety, and stress.\n\nEach subscale score ranges from 0 to 42, with higher scores indicating greater levels of depression, anxiety, or stress.\n\nChanges in total and subscale scores over time will be used to evaluate the psychological impact of the intervention on caregivers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm infants', 'Environmental enrichment', 'Home-based intervention', 'Early intervention', 'Brain development', 'Cognitive development', 'Motor development', 'Neurodevelopment'], 'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of a structured environmental enrichment (EE)-based early developmental intervention on brain, motor, and cognitive outcomes in preterm infants. Infants born before 37 weeks of gestation are at increased risk for alterations in structural and functional brain development, which may be further influenced by the neonatal intensive care environment, including exposure to excessive light, noise, and frequent medical procedures.\n\nThe intervention is a prospectively implemented, home-based developmental program structured according to the HEP (Homeostasis-Enrichment-Plasticity) approach, providing enriched sensory-motor experiences, environmental novelty, problem-solving activities, and opportunities for active exploration. The program is delivered through guided parental involvement with support from trained therapists, according to a predefined protocol.\n\nDevelopmental outcomes will be assessed at baseline and after the intervention period using standardized, non-invasive assessment tools. The intervention does not include any pharmacological treatment or medical device. This study evaluates whether participation in an EE-based early developmental intervention leads to improved neurodevelopmental outcomes in preterm infants.', 'detailedDescription': "The purpose of this study is to investigate the effects of an environmental enrichment (EE)-based early developmental intervention on brain, motor, and cognitive development in preterm infants. Infants born before 37 weeks of gestation are at increased risk for alterations in brain structure and subsequent neurodevelopmental challenges. In addition to biological vulnerability, early sensory experiences and environmental factors may influence developmental trajectories during infancy.\n\nThis study will examine developmental outcomes together with brain morphometric measurements and urinary biochemical markers, including brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), Tau, and S100B.\n\nObjectives:\n\n1. To assess urinary biochemical markers, brain morphometry, and motor and cognitive development in preterm infants at corrected 1 month of age.\n2. To examine relationships among urinary biochemical markers, brain morphometry, and developmental outcomes at baseline.\n3. To compare changes in biochemical, neuroimaging, and developmental outcomes over a 12-week period between infants receiving standard care and those receiving an EE-based intervention.\n\nStudy Design:\n\nA total of 28 preterm infants born before 37 weeks of gestation will be enrolled. The study will begin when infants reach corrected 1 month of age. Participants will be allocated into two parallel groups using stratified assignment based on relevant clinical characteristics.\n\nStandard Care Group:\n\nInfants in the standard care group will continue to receive routine medical follow-up and developmental monitoring as provided by their healthcare services. No additional intervention beyond usual care will be introduced as part of the study.\n\nEnvironmental Enrichment (HEP) Intervention Group:\n\nInfants in the intervention group will receive a structured environmental enrichment-based developmental program guided by a therapist through weekly in-person sessions. The intervention is based on the Homeostasis-Enrichment-Plasticity (HEP) approach and focuses on providing enriched sensory-motor experiences, environmental novelty, problem-solving opportunities, and active exploration appropriate to the infant's corrected age.\n\nWeekly sessions are conducted by a trained therapist and are designed to support infant-environment interaction, promote motor and cognitive engagement, and coach caregivers in implementing developmentally appropriate practices. In addition to the therapist-guided sessions, caregivers are encouraged to integrate the HEP-based practices into their daily routines at home.\n\nAll intervention components are non-invasive, behavioral, and developmentally supportive in nature. No pharmacological treatments, invasive procedures, or medical devices are used as part of the intervention.\n\nProcedures:\n\nUrinary biochemical markers: Urine samples will be collected from all infants at baseline (corrected 1 month of age) and after the 12-week intervention period to measure levels of BDNF, NGF, Tau, and S100B. Samples will be stored at -80°C until analysis.\n\nBrain imaging: Cranial ultrasonography obtained as part of routine clinical care will be used for morphometric analysis. No additional imaging procedures will be performed solely for research purposes.\n\nDevelopmental assessment: Motor development will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) Motor Scale and the Test of Infant Motor Performance (TIMP). Cognitive development will be evaluated using the Bayley-III Cognitive Scale.\n\nCaregiver well-being: Caregivers will complete the Depression Anxiety Stress Scales-21 (DASS-21) to assess caregiver psychological status.\n\nFollow-up and Analysis:\n\nAll outcome measures, including urinary biochemical markers, cranial ultrasonography, developmental assessments, and caregiver questionnaires, will be repeated after the 12-week intervention period. Statistical analyses will examine within- and between-group changes over time, as well as associations among biochemical markers, brain morphometry, and developmental outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Weeks', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Preterm infants born before 37 completed weeks of gestation.\n* Corrected age between 4 and 7 weeks at the time of enrollment.\n* Medically stable, as confirmed by the attending neonatologist\n* Written informed consent obtained from parents or legal guardians.\n\nExclusion Criteria\n\n* Major congenital anomalies or known genetic syndromes.\n* Severe intraventricular hemorrhage (Grade III-IV) or other major neurological impairment.\n* Unstable medical conditions that would interfere with safe participation in the study procedures.\n* Caregivers unable to attend scheduled study sessions or comply with study-related procedures.'}, 'identificationModule': {'nctId': 'NCT07343505', 'acronym': 'PRE-ENV', 'briefTitle': 'Environmental Enrichment Intervention and Brain Development in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'A Prospective Study Investigating the Effects of an Environmental Enrichment-Based Intervention on Brain Development in Preterm Infants', 'orgStudyIdInfo': {'id': 'ESOGU-TA-PretermEE-001'}, 'secondaryIdInfos': [{'id': 'TDK-2025-3575', 'type': 'OTHER_GRANT', 'domain': 'Scientific Research Projects (BAP), Eskisehir Osmangazi University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Infants in this group will receive conventional developmental therapy and routine medical follow-up as provided within standard clinical practice. This approach represents an active comparator and does not include the structured environmental enrichment or the Homeostasis-Enrichment-Plasticity (HEP)-based intervention used in the experimental group. Participants in this group will undergo the same study-related assessments as the intervention group at baseline and after 12 weeks.', 'interventionNames': ['Other: Standard Developmental Care']}, {'type': 'EXPERIMENTAL', 'label': 'HEP Home-Practice Group:', 'description': 'A structured environmental enrichment-based developmental intervention delivered over a 12-week period. The program is based on the Homeostasis-Enrichment-Plasticity (HEP) framework and includes age-appropriate sensory-motor activities, environmental novelty, problem-solving opportunities, and active caregiver-infant interaction. The intervention is delivered through weekly therapist-guided sessions, with caregivers encouraged to continue the practices at home as part of daily care.', 'interventionNames': ['Behavioral: Environmental Enrichment-Based Intervention']}], 'interventions': [{'name': 'Standard Developmental Care', 'type': 'OTHER', 'description': 'Standard developmental care and routine medical follow-up provided within usual clinical practice. This care reflects established developmental support approaches typically offered to preterm infants and does not include structured environmental enrichment or the Homeostasis-Enrichment-Plasticity (HEP)-based intervention applied in the experimental group.', 'armGroupLabels': ['Control Group']}, {'name': 'Environmental Enrichment-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Environmental enrichment-based program applied for 12 weeks, including sensory-motor stimulation, environmental novelty, problem-solving tasks, and active exploration with caregivers.', 'armGroupLabels': ['HEP Home-Practice Group:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Nilufer', 'state': 'Bursa', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tuğçe Altıok, PhD', 'role': 'CONTACT', 'email': '522620221000@ogrenci.ogu.edu.tr', 'phone': '+90 555 101 74 93'}, {'name': 'Tuğçe Altıok, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aymen Balıkçı, PT, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tuğçe Altıok Physical Therapy Center', 'geoPoint': {'lat': 40.21401, 'lon': 28.91567}}], 'centralContacts': [{'name': 'Tuğçe Altıok, PhD / PT', 'role': 'CONTACT', 'email': '522620221000@ogrenci.ogu.edu.tr', 'phone': '+90 555 101 74 93'}, {'name': 'Ferruh Yücel, Professor, PhD', 'role': 'CONTACT', 'email': 'yferruh@gmail.com', 'phone': '+90 533 626 64 58'}], 'overallOfficials': [{'name': 'Tuğçe Altıok, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eskisehir Osmangazi University, Institute of Health Sciences'}, {'name': 'Ferruh Yücel, Professor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eskisehir Osmangazi University'}, {'name': 'Aymen Balıkçı, PT, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aymen Balıkçı Physical Therapy Clinic'}, {'name': 'Teresa A. May-Benson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teresa A. May-Benson Therapy Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Tuğçe Altıok', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}