Preterm BirthPRE-ENVNCT07343505
Environmental Enrichment Intervention and Brain Development in Preterm Infants
A study testing Standard Developmental Care and Environmental Enrichment-Based Intervention in people with Preterm Birth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 7 weeks
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Standard Developmental Care and Environmental Enrichment-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born before 37 completed weeks of gestation.
- Corrected age between 4 and 7 weeks at the time of enrollment.
- Medically stable, as confirmed by the attending neonatologist
- Written informed consent obtained from parents or legal guardians.
Who cannot join
- Major congenital anomalies or known genetic syndromes.
- Severe intraventricular hemorrhage (Grade III-IV) or other major neurological impairment.
- Unstable medical conditions that would interfere with safe participation in the study procedures.
- Caregivers unable to attend scheduled study sessions or comply with study-related procedures.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tuğçe Altıok Physical Therapy Center
Nilufer, Bursa, 16110
About this study
Official title: A Prospective Study Investigating the Effects of an Environmental Enrichment-Based Intervention on Brain Development in Preterm Infants
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.
The 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.
Developmental 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.
Read the detailed description
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.
This 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.
Objectives:
- To assess urinary biochemical markers, brain morphometry, and motor and cognitive development in preterm infants at corrected 1 month of age.
- To examine relationships among urinary biochemical markers, brain morphometry, and developmental outcomes at baseline.
- 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.
Study Design:
A 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.
Standard Care Group:
Infants 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.
Environmental Enrichment (HEP) Intervention Group:
Infants 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.
Weekly 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.
All 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.
Procedures:
Urinary 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.
Brain 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.
Developmental 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.
Caregiver well-being: Caregivers will complete the Depression Anxiety Stress Scales-21 (DASS-21) to assess caregiver psychological status.
Follow-up and Analysis:
All 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.
- Conditions
- Preterm Birth
- Being tested
- Standard Developmental Care, Environmental Enrichment-Based Intervention
- Keywords
- Preterm infants, Environmental enrichment, Home-based intervention, Early intervention, Brain development, Cognitive development, Motor development, Neurodevelopment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Developmental CareOther
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.
Environmental Enrichment-Based InterventionBehavioural
Environmental enrichment-based program applied for 12 weeks, including sensory-motor stimulation, environmental novelty, problem-solving tasks, and active exploration with caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Standard Developmental Care |
| HEP Home-Practice Group: | Experimental | 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. Receives: Behavioral: Environmental Enrichment-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
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.
The Motor Composite Score ranges from 40 to 160, with higher scores indicating better motor development.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Motor Performance Assessed by Test of Infant Motor Performance (TIMP)
Motor performance will be assessed using the Test of Infant Motor Performance (TIMP), which evaluates postural and selective control of movement in young infants.
The TIMP total score ranges from -49 to 142, with higher scores indicating better motor performance.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Secondary outcomes (7)
Cognitive Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
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.
The Cognitive Composite Score ranges from 40 to 160, with higher scores indicating better cognitive development.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Brain Morphometric Measurements Assessed by Cranial Ultrasound Imaging
Brain structural development will be evaluated using cranial ultrasound imaging with morphometric measurements, including ventricular size and selected linear brain dimensions.
Changes 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.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Brain-Derived Neurotrophic Factor (BDNF)
Urine samples will be collected to measure the concentration of brain-derived neurotrophic factor (BDNF) using standardized immunoassay methods.
BDNF levels will be reported as urinary concentration, and changes in concentration over time will be used to evaluate neurodevelopmental effects of the intervention.
Higher BDNF levels indicate enhanced neurotrophic support.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Nerve Growth Factor (NGF)
Urine samples will be collected to measure the concentration of nerve growth factor (NGF) using standardized immunoassay methods.
NGF levels will be reported as urinary concentration, and changes in concentration over time will be used to assess neurodevelopmental support.
Higher NGF levels indicate enhanced neurodevelopmental processes.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Tau Protein
Urine samples will be collected to measure the concentration of Tau protein using standardized immunoassay methods.
Tau levels will be reported as urinary concentration, and changes in concentration over time will be interpreted in relation to neuronal integrity.
Alterations in Tau concentration may reflect changes in neuronal structure or injury.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of S100 Calcium-Binding Protein B (S100B)
Urine samples will be collected to measure the concentration of S100 calcium-binding protein B (S100B) using standardized immunoassay methods.
S100B levels will be reported as urinary concentration, and changes in concentration over time will be used to evaluate brain structural integrity.
Elevated S100B levels are interpreted in relation to brain tissue stress or injury.
Measured: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Depression, Anxiety, and Stress Scale-21 Items (DASS-21) Total and Subscale Scores in Caregivers
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.
Each subscale score ranges from 0 to 42, with higher scores indicating greater levels of depression, anxiety, or stress.
Changes in total and subscale scores over time will be used to evaluate the psychological impact of the intervention on caregivers.
Measured: Baseline and 12 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Altıok, Eskisehir Osmangazi University
- Investigators
- Tuğçe Altıok, PhD, Study director, Eskisehir Osmangazi University, Institute of Health SciencesFerruh Yücel, Professor, PhD, Principal investigator, Eskisehir Osmangazi UniversityAymen Balıkçı, PT, PhD, Study director, Aymen Balıkçı Physical Therapy ClinicTeresa A. May-Benson, PhD, Study director, Teresa A. May-Benson Therapy Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343505
- Sponsor's protocol ID
- ESOGU-TA-PretermEE-001
- Other IDs
- TDK-2025-3575
- Acronym
- PRE-ENV
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Investigating the Effects of an Environmental Enrichment-Based Intervention on Brain Development in Preterm Infants
- ClinicalTrials.gov ID
- NCT07343505
- Acronym / sponsor ID
- PRE-ENV / ESOGU-TA-PretermEE-001
- Conditions
- Preterm Birth
- Keywords
- Preterm infants, Environmental enrichment, Home-based intervention, Early intervention, Brain development, Cognitive development, Motor development, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
Developmental 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.
Detailed description
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.
This 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.
Objectives:
- To assess urinary biochemical markers, brain morphometry, and motor and cognitive development in preterm infants at corrected 1 month of age.
- To examine relationships among urinary biochemical markers, brain morphometry, and developmental outcomes at baseline.
- 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.
Study Design:
A 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.
Standard Care Group:
Infants 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.
Environmental Enrichment (HEP) Intervention Group:
Infants 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.
Weekly 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.
All 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.
Procedures:
Urinary 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.
Brain 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.
Developmental 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.
Caregiver well-being: Caregivers will complete the Depression Anxiety Stress Scales-21 (DASS-21) to assess caregiver psychological status.
Follow-up and Analysis:
All 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Developmental CareInfants 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. |
| HEP Home-Practice Group: | Experimental | Behavioral: Environmental Enrichment-Based InterventionA 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. |
Who may qualify
- Ages
- 4 to 7 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born before 37 completed weeks of gestation.
- Corrected age between 4 and 7 weeks at the time of enrollment.
- Medically stable, as confirmed by the attending neonatologist
- Written informed consent obtained from parents or legal guardians.
Key exclusion criteria (4 listed)
- Major congenital anomalies or known genetic syndromes.
- Severe intraventricular hemorrhage (Grade III-IV) or other major neurological impairment.
- Unstable medical conditions that would interfere with safe participation in the study procedures.
- Caregivers unable to attend scheduled study sessions or comply with study-related procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Developmental CareStandard 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. | Other | Control Group |
| Environmental Enrichment-Based InterventionEnvironmental enrichment-based program applied for 12 weeks, including sensory-motor stimulation, environmental novelty, problem-solving tasks, and active exploration with caregivers. | Behavioural | HEP Home-Practice Group: |
Primary outcome
Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
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. The Motor Composite Score ranges from 40 to 160, with higher scores indicating better motor development.
Motor Performance Assessed by Test of Infant Motor Performance (TIMP)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Motor performance will be assessed using the Test of Infant Motor Performance (TIMP), which evaluates postural and selective control of movement in young infants. The TIMP total score ranges from -49 to 142, with higher scores indicating better motor performance.
7 secondary outcomes
Cognitive Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Brain Morphometric Measurements Assessed by Cranial Ultrasound Imaging
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Nerve Growth Factor (NGF)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of Tau Protein
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Urinary Concentration of S100 Calcium-Binding Protein B (S100B)
Time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
Depression, Anxiety, and Stress Scale-21 Items (DASS-21) Total and Subscale Scores in Caregivers
Time frame: Baseline and 12 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğçe Altıok, PhD study director
Eskisehir Osmangazi University, Institute of Health Sciences
Ferruh Yücel, Professor, PhD principal investigator
Eskisehir Osmangazi University
Aymen Balıkçı, PT, PhD study director
Aymen Balıkçı Physical Therapy Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Developmental Care and Environmental Enrichment-Based Intervention in people with Preterm Birth, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) (time frame: Baseline (corrected age of 1 month) and 12 weeks (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.