Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants (NCT05261503) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants
Turkey (Türkiye)29 participantsStarted 2022-03-01
Plain-language summary
The aim of this study is to investigate the effectiveness the HEP (Homeostasis-Enrichment-Plasticity) approach, which based upon the principles of enriched environment (EE) and ecological theories of development on preterm infants with developmental delay risk.
Thirty-two preterm infants aged 4-10 months will be randomly divided into 2 groups as the HEP intervention group and the Traditional Physical Therapy (TPT) group.
EE-based intervention will be applied to the HEP intervention group, and traditional physiotherapy will be applied to the TPT group for 12 weeks (24 sessions).
The demographic information of the participants will be recorded. The motor and sensory functions of the infants will be evaluated with, the Peabody Developmental Motor Scales (PDMS-2) and the Test of Sensory Functions in Infants™ (TSFI™), respectively. Additionally, the anxiety status of the parents will be evaluated with the Beck Anxiety Inventory (BAI). All evaluations will be done twice, at the end and at the beginning of 12 weeks.
Who can participate
Age range
4 Months – 10 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* To be in corrected age between 4 and 10 months
* To being born 33 weeks and 6 days of gestation and before,
* To absence of any systemic disease, congenital anomaly,
* The family's volunteer to participate regularly in the study process.
* Having abnormal or suspect results on the Denver Developmental Screening Test II
Exclusion Criteria:
* To be born at or after 34 weeks of gestational age
* To having experienced intraventricular bleeding (Grade III and IV),
* To having major vision or hearing problems
* To having medical conditions that prevent active participation in the study (such as oxygen dependence)
* To participate in other experimental rehabilitation studies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motor Skills PDMS-2 Peabody Developmental Motor Scales 2nd Edition