PretermNCT05261503
Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants
A study testing HEP and Traditional Phsical Therapy in people with Preterm and Motor, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 months
- Conditions the study is for
- Preterm, Motor, Development, Infant
- What is being tested?
- HEP and Traditional Phsical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Premature birth is defined by WHO (World Health Organization) as all births occurring before 37 weeks of gestation. The global preterm birth rate for 2014 is estimated at 10.6% (9%-12%), equating to an estimated 14.84 million (12.65 million-16.73 million) live preterm births in 2014.
Preterm birth results in significant healthcare utilization and costs. Families of preterm infants often experience significant psychological and significant psychological and financial difficulties. Preterm infants have an increased risk for social, cognitive, language, sensory processing and motor skill disorders. There are different early intervention methods for preterm infants, and enriched environment (EE)-based intervention is one of the current intervention methods that have been used recently. There are studies showing that EE-based interventions have neurobehavioral benefits and positively affect brain functions and motor development.
There are a limited number of studies on EE-based early intervention methods in the literature, and these studies were conducted in different age and diagnosis groups by applying different intervention methods. Therefore, more studies are needed on this subject.
In this study, it was aimed to contribute to the literature in this field and to investigate the effectiveness of an EE-based intervention on the sensory and motor functions of preterm infants and the emotional state of the family.
- Conditions
- Preterm, Motor, Development, Infant, Therapy
- Being tested
- HEP, Traditional Phsical Therapy
- Keywords
- Preterm, Infant, Enriched Environment, Sensory, Motor, Development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPOther
The Homeostasis-Enrichment-Plasticity (HEP) intervention group will receive 45 minutes of face-to-face environmental enrichment-based intervention one day per week and online home support once a week for 12 weeks.
Traditional Phsical TherapyOther
The Traditional Physical Therapy group will receive a 45-minute intervention, two days a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Homeostasis-Enrichment-Plasticity | Experimental | HEP group will receive an environmental enrichment-based intervention. Receives: Other: HEP |
| Traditional Physical Therapy | Experimental | TPT group will receive traditional physiotherapy intervention. Receives: Other: Traditional Phsical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Skills PDMS-2 Peabody Developmental Motor Scales 2nd Edition
The Peabody Developmental Motor Scales 2nd Edition (PDMS-2):
PDMS-2 evaluates fine and gross motor skills of children from birth to six years of age relative to their peers. There are four subtests on gross motor skills (Reflexes, stationary performances, locomotion, object manipulation) and two subtests on fine motor skills (Grasping, visual-motor integration).
In the test, the skills to be assessed are listed in chronological order. The test starts at the child's age-appropriate beginner level (the level at which he gets 2 points on three items in a row) and ends when the child scores 0 on each of the three items in a row.
Each item is scored as 0 (does not show performance criteria), 1 (shows some of the performance criteria), 2 (shows performance criteria) according to the child's performance, and the total score for each section is calculated at the end of the test.
Measured: 12 weeks
Sensory Function
Test of Sensory Functions in Infants™ (TSFI™):
TSFI consists of 5 subtests and 24 items. The application time is approximately 20 minutes.
In the subtests of the test, reactivity to tactile deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and reactivity to vestibular stimulation are evaluated and all items are scored.
The infant is evaluated as normal, at-risk, or deficient in terms of sensory processing according to the total score he/she gets. A higher score indicates better sensory processing.
Measured: 12 weeks
Secondary outcomes (1)
Mental Health
Beck Anxiety Inventory (BAI):
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items that question physical and cognitive anxiety symptoms such as hot flashes, fear of something bad happening to oneself, heart palpitations, irritability, fear of drowning, and sweating not related to heat.
The individual scores from 0 to 3 how intensely they have experienced these symptoms during the past week. The total score may range from 0 and 63: 0-7 points indicate minimal anxiety, 8-15 points indicate mild anxiety, 16-25 points indicate moderate anxiety, and 26-63 points indicate severe anxiety.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2022
- Primary completion1 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Cagla Sirma, Istanbul University - Cerrahpasa
- Investigators
- Aymen Balıkçı, Asst. Prof., Study director, Fenerbahce UniversityGamze Çağla Sırma, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261503
- Sponsor's protocol ID
- EE Intervention in Preterm
- Status last verified
- Jun 2023
- First submitted
- 20 Feb 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants
- ClinicalTrials.gov ID
- NCT05261503
- Acronym / sponsor ID
- EE Intervention in Preterm
- Conditions
- Preterm, Motor, Development, Infant, Therapy
- Keywords
- Preterm, Infant, Enriched Environment, Sensory, Motor, Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 2 Mar 2022 (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.
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.
Detailed description
Premature birth is defined by WHO (World Health Organization) as all births occurring before 37 weeks of gestation. The global preterm birth rate for 2014 is estimated at 10.6% (9%-12%), equating to an estimated 14.84 million (12.65 million-16.73 million) live preterm births in 2014.
Preterm birth results in significant healthcare utilization and costs. Families of preterm infants often experience significant psychological and significant psychological and financial difficulties. Preterm infants have an increased risk for social, cognitive, language, sensory processing and motor skill disorders. There are different early intervention methods for preterm infants, and enriched environment (EE)-based intervention is one of the current intervention methods that have been used recently. There are studies showing that EE-based interventions have neurobehavioral benefits and positively affect brain functions and motor development.
There are a limited number of studies on EE-based early intervention methods in the literature, and these studies were conducted in different age and diagnosis groups by applying different intervention methods. Therefore, more studies are needed on this subject.
In this study, it was aimed to contribute to the literature in this field and to investigate the effectiveness of an EE-based intervention on the sensory and motor functions of preterm infants and the emotional state of the family.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeostasis-Enrichment-Plasticity | Experimental | Other: HEPHEP group will receive an environmental enrichment-based intervention. |
| Traditional Physical Therapy | Experimental | Other: Traditional Phsical TherapyTPT group will receive traditional physiotherapy intervention. |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| HEPThe Homeostasis-Enrichment-Plasticity (HEP) intervention group will receive 45 minutes of face-to-face environmental enrichment-based intervention one day per week and online home support once a week for 12 weeks. | Other | Homeostasis-Enrichment-Plasticity |
| Traditional Phsical TherapyThe Traditional Physical Therapy group will receive a 45-minute intervention, two days a week for 12 weeks. | Other | Traditional Physical Therapy |
Primary outcome
Motor Skills PDMS-2 Peabody Developmental Motor Scales 2nd Edition
Time frame: 12 weeks
The Peabody Developmental Motor Scales 2nd Edition (PDMS-2): PDMS-2 evaluates fine and gross motor skills of children from birth to six years of age relative to their peers. There are four subtests on gross motor skills (Reflexes, stationary performances, locomotion, object manipulation) and two subtests on fine motor skills (Grasping, visual-motor integration). In the test, the skills to be assessed are listed in chronological order. The test starts at the child's age-appropriate beginner level (the level at which he gets 2 points on three items in a row) and ends when the child scores 0 on each of the three items in a row. Each item is scored as 0 (does not show performance criteria), 1 (shows some of the performance criteria), 2 (shows performance criteria) according to the child's performance, and the total score for each section is calculated at the end of the test.
Sensory Function
Time frame: 12 weeks
Test of Sensory Functions in Infants™ (TSFI™): TSFI consists of 5 subtests and 24 items. The application time is approximately 20 minutes. In the subtests of the test, reactivity to tactile deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and reactivity to vestibular stimulation are evaluated and all items are scored. The infant is evaluated as normal, at-risk, or deficient in terms of sensory processing according to the total score he/she gets. A higher score indicates better sensory processing.
1 secondary outcome
Mental Health
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
Aymen Balıkçı, Asst. Prof. study director
Fenerbahce University
Gamze Çağla Sırma principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEP and Traditional Phsical Therapy in people with Preterm and Motor, run by Istanbul University - Cerrahpasa 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Skills PDMS-2 Peabody Developmental Motor Scales 2nd Edition (time frame: 12 weeks). 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 7 Jun 2023.