Infant DevelopmentNCT06361134
Efficacy of Supporting SAFE Early Intervention
A study testing SAFE Early İntervention and NDT based therapy in people with Infant Development and Physiotherapy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Infant Development, Physiotherapy, Early Intervention
- What is being tested?
- SAFE Early İntervention and NDT based therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Nov 2022
- 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 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),
- Having a NICU history of 15 days or more,
Who cannot join
- congenital malformations, metabolic and genetic disease musculoskeletal system anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.
- Conditions
- Infant Development, Physiotherapy, Early Intervention
- Being tested
- SAFE Early İntervention, NDT based therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE Early İnterventionBehavioural
As part of the intervention, sensory-based intervention was applied in an enriched environment. In the home setting, physiotherapists collaborated with the family to advance the intervention. The intervention was revised by making monthly home visits to infants with a corrected age of 42 weeks.
NDT based therapyBehavioural
Neuromotor evaluations of the babies were performed in a clinical setting. The rehabilitation program to be implemented was given to the family as a booklet. The programs of the children examined in the clinic every month were revised.
| Study group | Role | What they receive |
|---|---|---|
| SAFE Early Intervention Group | Experimental | A sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks. Receives: Behavioral: SAFE Early İntervention; Behavioral: NDT based therapy |
| Control Group | Experimental | Home-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development. Receives: Behavioral: SAFE Early İntervention; Behavioral: NDT based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Profile
High numerical scores indicate that infants notice and respond to stimuli less than their peers, meaning the infant is hypersensitive, while low numerical scores indicate that infants notice and respond to stimuli more than their peers, or are hypersensitive.
Measured: 10 weeks
Secondary outcomes (3)
Bayley Scales of Infant and Toddler Development, Third Edition,
Bayley Scales of Infant and Toddler Development- III is the most widely used tool for assessment of early development.Bayley-III including Cognitive, Language, and Motor scales . "1" if the child meets the scoring criteria for each item; If the child does not meet the criteria, he receives a score of "0". Raw scores for each subtest are summed (Total Raw Score) and then converted to scale scores, composite scores, percentile ranks and confidence intervals using the tables provided in the manual. These scores are used to determine the child's performance compared to norms from typically developing children their age (in months).
Measured: 10 weeks
Infant/Toddler Sensory Profile 2
The Infant/Toddler Sensory Profile (ITSP) was developed in response to the need for a standardized assessment of sensory processing for infants and toddlers. The ITSP is a caregiver questionnaire designed to measure in-fant/toddler responses to various sensory stimuli. It has two age bands: birth to6 (0-6) months and 7 to 36 (7-36) months, with 36 and 48 items, respectively. Each itemon the ITSP describes a certain behavior that may occur in daily life, with the fre-quency of such behaviors rated by the caregiver on a five-point Likert scale (1=always, 2=frequently, 3=occasionally, 4=seldom, and 5=never).
Measured: 10 weeks
Infant/Toddler HOME Inventory
It is used to evaluate children's home environment. It evaluates the home environment of children aged 0-3 under six different subheadings. Parents rate the frequency of the child's behavior on a five-point scale from 1 (almost always) to 5 (almost never). The items in this test are; It evaluates six different areas: general, auditory, visual, tactile, vestibular and oral sensory processing. A higher score indicates that the answer occurs less frequently
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 posted11 Apr 2024
- Study start15 Jan 2021
- Primary completion15 May 2022
- Study completion15 Nov 2022
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 Infant DevelopmentStudies 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
- 26 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
- NCT06361134
- Sponsor's protocol ID
- 14574941-302,08,01-
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz A, Yildiz R, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study. Child Care Health Dev. 2025 Jul;51(4):e70107. doi: 10.1111/cch.70107.
PubMed 40435392
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06361134
- Acronym / sponsor ID
- 14574941-302,08,01-
- Conditions
- Infant Development, Physiotherapy, Early Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 11 Apr 2024 (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.
Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.
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 İntervention, Behavioral: NDT based therapyA sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks. |
| Control Group | Experimental | Behavioral: SAFE Early İntervention, Behavioral: NDT based therapyHome-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),
- Having a NICU history of 15 days or more,
Key exclusion criteria (1 listed)
- congenital malformations, metabolic and genetic disease musculoskeletal system anomaly
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 İnterventionAs part of the intervention, sensory-based intervention was applied in an enriched environment. In the home setting, physiotherapists collaborated with the family to advance the intervention. The intervention was revised by making monthly home visits to infants with a corrected age of 42 weeks. | Behavioural | Control Group, SAFE Early Intervention Group |
| NDT based therapyNeuromotor evaluations of the babies were performed in a clinical setting. The rehabilitation program to be implemented was given to the family as a booklet. The programs of the children examined in the clinic every month were revised. | Behavioural | Control Group, SAFE Early Intervention Group |
Primary outcome
Test of Infant Motor Profile
Time frame: 10 weeks
High numerical scores indicate that infants notice and respond to stimuli less than their peers, meaning the infant is hypersensitive, while low numerical scores indicate that infants notice and respond to stimuli more than their peers, or are hypersensitive.
3 secondary outcomes
Bayley Scales of Infant and Toddler Development, Third Edition,
Time frame: 10 weeks
Infant/Toddler Sensory Profile 2
Time frame: 10 weeks
Infant/Toddler HOME Inventory
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 11 Apr 2024.
- Derived from this study: PubMed 40435392Yildiz A, Yildiz R, Apaydin U, Efkere PA, Gucuyener K, Hirfanoglu IM, Elbasan B. Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study. Child Care Health Dev. 2025 Jul;51(4):e70107. doi: 10.1111/cch.70107.
Related trials for Infant Development
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
5 Year Old Children Born Prematurely
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 İntervention and NDT based therapy in people with Infant Development and Physiotherapy, 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 2 inclusion and 1 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 11 Apr 2024. 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?
Test of Infant Motor Profile (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 NCT06361134, 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 11 Apr 2024.