PretermNCT06930482
Evaluation of The Effectiveness of The SAFE Early Intervention Program
A study testing Safe early intervention and early intervention approach based on neurodevelopmental treatment in people with Preterm and Sensory Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Preterm, Sensory Disorders, Cerebral Palsy
- What is being tested?
- Safe early intervention and early intervention approach based on neurodevelopmental treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)
Who cannot join
- Having a genetic syndrome diagnosis (e.g. Down Syndrome)
- Parents do not speak Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP
In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.
- Conditions
- Preterm, Sensory Disorders, Cerebral Palsy
- Being tested
- Safe early intervention, early intervention approach based on neurodevelopmental treatment
- Medical subject headings
- Premature Birth, Sensation Disorders, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe early interventionBehavioural
The SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary.
early intervention approach based on neurodevelopmental treatmentBehavioural
Within the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention).
| Study group | Role | What they receive |
|---|---|---|
| SAFE Early Intervention Group | Experimental | Not described Receives: Behavioral: Safe early intervention; Behavioral: early intervention approach based on neurodevelopmental treatment |
| Control Group | Other | Not described Receives: Behavioral: Safe early intervention; Behavioral: early intervention approach based on neurodevelopmental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Development for Infants and Toddlers III (Bayley-III)
Measured: 3 months,6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930482
- Sponsor's protocol ID
- 91610558-302.08.01-122723
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz R, Yildiz A, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial. J Paediatr Child Health. 2025 Oct;61(10):1662-1670. doi: 10.1111/jpc.70191. Epub 2025 Sep 2.
PubMed 40891629
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP
- ClinicalTrials.gov ID
- NCT06930482
- Acronym / sponsor ID
- 91610558-302.08.01-122723
- Conditions
- Preterm, Sensory Disorders, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Apr 2025 (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 examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE Early Intervention Group | Experimental | Behavioral: Safe early intervention, Behavioral: early intervention approach based on neurodevelopmental treatment |
| Control Group | Other | Behavioral: Safe early intervention, Behavioral: early intervention approach based on neurodevelopmental treatment |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)
Key exclusion criteria (2 listed)
- Having a genetic syndrome diagnosis (e.g. Down Syndrome)
- Parents do not speak Turkish
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 interventionThe SAFE early intervention approach, an activity-focused, sensory intervention program, was applied to the babies in the intervention group in an enriched environment. As part of the intervention, coaching was provided in collaboration with the family on how to support the baby's development. For this purpose, family visits were made 15 days after the initial assessment and once a month. During these visits, the suggestions given to the family were repeated and all questions about the process were answered. It was discussed how the home environment should be structured in a way that is appropriate for the baby's development. The aims of the approaches applied were explained and information was provided about the follow-up process. In order to follow up on whether the family implemented the intervention, the family was interviewed by phone and the family was asked to keep an activity diary. | Behavioural | Control Group, SAFE Early Intervention Group |
| early intervention approach based on neurodevelopmental treatmentWithin the scope of the study, NGT-based applications were applied to the babies included in the control group by their families. After the first assessment, activities were planned to support skills appropriate to the child's developmental level. The treatment movements, how to facilitate the baby's movements, and how to provide hand contact were demonstrated to the families in practice. The applicability of the intervention program was monitored with weekly phone calls. The babies were called to the clinic environment for a check-up every month to revise the intervention program and teach new movements, and an evaluation was made. Two home visits were made to evaluate the families' home environments and parental attitudes (pre- and post-intervention). | Behavioural | Control Group, SAFE Early Intervention Group |
Primary outcome
Bayley Scales of Development for Infants and Toddlers III (Bayley-III)
Time frame: 3 months,6 months, 12 months
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 16 Apr 2025.
- Derived from this study: PubMed 40891629Yildiz R, Yildiz A, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Long-Term Neurodevelopmental Outcomes of the SAFE Early Intervention in Infants at Risk: A Randomised Controlled Trial. J Paediatr Child Health. 2025 Oct;61(10):1662-1670. doi: 10.1111/jpc.70191. Epub 2025 Sep 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and early intervention approach based on neurodevelopmental treatment in people with Preterm and Sensory Disorders, 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 1 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 16 Apr 2025. 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?
Bayley Scales of Development for Infants and Toddlers III (Bayley-III) (time frame: 3 months,6 months, 12 months). 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 NCT06930482, which also lists 1 linked publication.
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 Apr 2025.