Infant, Premature, DiseasesSAFENCT04889846
The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey
A study testing SAFE early intervention approach in people with Infant, Premature, Diseases, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in… Read more about this study
- Who is it for?
- Ages 9 to 10 months
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- SAFE early intervention approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 2 Nov 2021
- 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 9 to 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being born before 37 weeks
- A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
- Adjusted age to be between 9-10 months
- Family's willingness to participate in the study
Who cannot join
- Having a congenital anomaly or systemic disease
- Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Health Sciences Department of Pyhsiotherapy and Rehabilitation
Ankara, 06560
About this study
Official title: Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies, Activity Based Motor Training and Environmental Enrichment in Premature Infants: SAFE National Early Intervention Approach
In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.
Read the detailed description
Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.
Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).
In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.
- Conditions
- Infant, Premature, Diseases
- Being tested
- SAFE early intervention approach
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE early intervention approachProcedure or surgery
SAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.
| Study group | Role | What they receive |
|---|---|---|
| SAFE early intervention group | Experimental | A family collaborative treatment program based on sensory strategies, activity-based motor training and environmental enrichment principles was created for the infants in the treatment group. Within the scope of the SAFE treatment approach, appropriate activities were explained to the families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. The homes of the families in the treatment group were visited at least once. During this visit, home environment was evaluated. In order to create an enriched home environment, families were informed about the toys and materials that can be obtained. The family's questions about the program were answered. Receives: Procedure: SAFE early intervention approach |
| Control group | Experimental | Within the scope of this study, the infants in the control group were given an NDT-based family training program in accordance with their corrected months and current functional levels. In this context, appropriate activities were taught to families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. One visit was made to the homes of the families in the control group. The family's questions about the program were answered. Receives: Procedure: SAFE early intervention approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Bayley-III is a widely used test battery to assess cognitive, receptive and expressive language, gross and fine motor development in children aged 1 to 42 months. The items in each section are scored as 1 (can do the desired skill) and 0 (cannot do the desired skill). The raw scores obtained from all items are converted into scale points ranging from 1 to 19 points. Then, a composite score is obtained according to this scale score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. The higher the score, the better the improvement.
Measured: 10 weeks
Secondary outcomes (5)
Hammersmith Infant Neurological Examination (HINE)
HINE is an easy-to-apply, standardized and scorable test used for clinical neurological evaluation of babies aged 2-24 months. The test consists of 3 parts. The first part is the scoring neurological examination section, which consists of 26 items that evaluate cranial nerve function, posture, movements, tone, reflexes and reactions. The second section is the motor milestones section and consists of 8 items that cannot be scored. The third part is the behavior section that cannot be scored and consists of 3 items. The first 26-item section can be scored as 0,1,2,3. The total score that can be obtained in HINE is 78. While the optimal score for 9-12 month infants is 73, this score is 70 for 6 month infants. Scores below 57 points per month indicate a great risk for the diagnosis of Cerebral Palsy (CP).
Measured: 10 weeks
The Test of Sensory Functions in Infants (TSFI)
TSFI evaluates sensory processing and reactivity in infants aged 4-18 months. TSFI consists of 5 subtests: response to tactile deep pressure, adaptive motor response, visual-tactile integration, oculo-motor test, and response to vestibular stimulation. All subtests consist of a total of 24 items. The total score ranges from 0 to 49. In 10-12 month-old infants, a score between 44-49 indicates good sensory function, 41-43 points indicate risky status, 0-40 points indicate sensory processing problem.
Measured: 10 weeks
Canadian Occupational Performance Measure (COPM)
Secondary outcomes included the COPM an individualised criterion-referenced measure of performance and satisfaction with performance of a parent-selected range of activities. In this study COPM was used at baseline to prioritise parent goals for their infants development and assess parents perception of their infants performance on identified goals and their own satisfaction with the infants current ability.
Measured: 10 weeks
Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)
Enrichment of the home environment was assessed with the AHEMD-IS. AHEMD-IS identifies opportunities available within the home to promote motor development, including characteristics of the indoor and outdoor environment and the presence of a range of toys and equipment. Total score possible for infants younger than 11 months is 66 while from 12 months possible total score is 93, to account for the expected increase in available learning materials.
Measured: 10 weeks
The Depression, Anxiety and Stress Scales-Short Form (DASS-21)
DASS-21 is a questionnaire that evaluates the depression, anxiety and stress states of individuals. DASS-21 is a 21-item assessment tool developed from the 42-item long form of the scale. DASS-21 is specified as an easily applicable and low-cost scale. It has been shown to be effective in detecting patients with depressive and anxiety disorders.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start15 Oct 2019
- Primary completion17 Oct 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Model description
- Single blind randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Apaydin, Gazi University
- Investigators
- Bülent Elbasan, Prof, Study director, Gazi University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889846
- Sponsor's protocol ID
- E-77082166-302.08.01-48434
- Acronym
- SAFE
- Status last verified
- Nov 2021
- First submitted
- 9 May 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hielkema T, Blauw-Hospers CH, Dirks T, Drijver-Messelink M, Bos AF, Hadders-Algra M. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation. Dev Med Child Neurol. 2011 Mar;53(3):e8-15. doi: 10.1111/j.1469-8749.2010.03876.x.
PubMed 21291457Morgan C, Novak I, Badawi N. Enriched environments and motor outcomes in cerebral palsy: systematic review and meta-analysis. Pediatrics. 2013 Sep;132(3):e735-46. doi: 10.1542/peds.2012-3985. Epub 2013 Aug 19.
PubMed 23958771Morgan C, Novak I, Dale RC, Guzzetta A, Badawi N. Single blind randomised controlled trial of GAME (Goals - Activity - Motor Enrichment) in infants at high risk of cerebral palsy. Res Dev Disabil. 2016 Aug;55:256-67. doi: 10.1016/j.ridd.2016.04.005. Epub 2016 May 7.
PubMed 27164480Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, Thacker LR, Molinini RM. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol. Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.
PubMed 32329778Pekcetin S, Aki E, Ustunyurt Z, Kayihan H. The Efficiency of Sensory Integration Interventions in Preterm Infants. Percept Mot Skills. 2016 Oct;123(2):411-23. doi: 10.1177/0031512516662895. Epub 2016 Aug 10.
PubMed 27511923Apaydin U, Yildiz R, Yildiz A, Acar SS, Gucuyener K, Elbasan B. Short-term effects of SAFE early intervention approach in infants born preterm: A randomized controlled single-blinded study. Brain Behav. 2023 Oct;13(10):e3199. doi: 10.1002/brb3.3199. Epub 2023 Aug 3.
PubMed 37534617
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies, Activity Based Motor Training and Environmental Enrichment in Premature Infants: SAFE National Early Intervention Approach
- ClinicalTrials.gov ID
- NCT04889846
- Acronym / sponsor ID
- SAFE / E-77082166-302.08.01-48434
- Conditions
- Infant, Premature, Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 17 May 2021 (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.
In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.
Detailed description
Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.
Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).
In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| SAFE early intervention group | Experimental | Procedure: SAFE early intervention approachA family collaborative treatment program based on sensory strategies, activity-based motor training and environmental enrichment principles was created for the infants in the treatment group. Within the scope of the SAFE treatment approach, appropriate activities were explained to the families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. The homes of the families in the treatment group were visited at least once. During this visit, home environment was evaluated. In order to create an enriched home environment, families were informed about the toys and materials that can be obtained. The family's questions about the program were answered. |
| Control group | Experimental | Procedure: SAFE early intervention approachWithin the scope of this study, the infants in the control group were given an NDT-based family training program in accordance with their corrected months and current functional levels. In this context, appropriate activities were taught to families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. One visit was made to the homes of the families in the control group. The family's questions about the program were answered. |
Who may qualify
- Ages
- 9 to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being born before 37 weeks
- A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
- Adjusted age to be between 9-10 months
- Family's willingness to participate in the study
Key exclusion criteria (2 listed)
- Having a congenital anomaly or systemic disease
- Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).
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 |
|---|---|---|
| SAFE early intervention approachSAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment. | Procedure or surgery | Control group, SAFE early intervention group |
Primary outcome
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: 10 weeks
Bayley-III is a widely used test battery to assess cognitive, receptive and expressive language, gross and fine motor development in children aged 1 to 42 months. The items in each section are scored as 1 (can do the desired skill) and 0 (cannot do the desired skill). The raw scores obtained from all items are converted into scale points ranging from 1 to 19 points. Then, a composite score is obtained according to this scale score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. The higher the score, the better the improvement.
5 secondary outcomes
Hammersmith Infant Neurological Examination (HINE)
Time frame: 10 weeks
The Test of Sensory Functions in Infants (TSFI)
Time frame: 10 weeks
Canadian Occupational Performance Measure (COPM)
Time frame: 10 weeks
Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)
Time frame: 10 weeks
The Depression, Anxiety and Stress Scales-Short Form (DASS-21)
Time frame: 10 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 3 Nov 2021.
- Background: PubMed 21291457Hielkema T, Blauw-Hospers CH, Dirks T, Drijver-Messelink M, Bos AF, Hadders-Algra M. Does physiotherapeutic intervention affect motor outcome in high-risk infants? An approach combining a randomized controlled trial and process evaluation. Dev Med Child Neurol. 2011 Mar;53(3):e8-15. doi: 10.1111/j.1469-8749.2010.03876.x.
- Background: PubMed 23958771Morgan C, Novak I, Badawi N. Enriched environments and motor outcomes in cerebral palsy: systematic review and meta-analysis. Pediatrics. 2013 Sep;132(3):e735-46. doi: 10.1542/peds.2012-3985. Epub 2013 Aug 19.
- Background: PubMed 27164480Morgan C, Novak I, Dale RC, Guzzetta A, Badawi N. Single blind randomised controlled trial of GAME (Goals - Activity - Motor Enrichment) in infants at high risk of cerebral palsy. Res Dev Disabil. 2016 Aug;55:256-67. doi: 10.1016/j.ridd.2016.04.005. Epub 2016 May 7.
- Background: PubMed 32329778Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, Thacker LR, Molinini RM. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol. Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.
- Background: PubMed 27511923Pekcetin S, Aki E, Ustunyurt Z, Kayihan H. The Efficiency of Sensory Integration Interventions in Preterm Infants. Percept Mot Skills. 2016 Oct;123(2):411-23. doi: 10.1177/0031512516662895. Epub 2016 Aug 10.
- Derived from this study: PubMed 37534617Apaydin U, Yildiz R, Yildiz A, Acar SS, Gucuyener K, Elbasan B. Short-term effects of SAFE early intervention approach in infants born preterm: A randomized controlled single-blinded study. Brain Behav. 2023 Oct;13(10):e3199. doi: 10.1002/brb3.3199. Epub 2023 Aug 3.
- Individual participant dataSharing planned: No
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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.
Bülent Elbasan, Prof study director
Gazi University Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFE early intervention approach in people with Infant, Premature, Diseases, run by Gazi 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 2 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 3 Nov 2021. 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?
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889846, which also lists 6 linked publications.
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 3 Nov 2021.