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Efficacy of Supporting SAFE Early Intervention

Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06361134
Enrollment
26
Registered
2024-04-11
Start date
2021-01-15
Completion date
2022-11-15
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Intervention, Infant Development, Physiotherapy

Brief 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. Sensory, motor and language development of the babies were evaluated before and after the intervention.

Interventions

BEHAVIORALSAFE Early İntervention

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.

BEHAVIORALNDT based therapy

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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
No

Inclusion criteria

Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy), Having a NICU history of 15 days or more,

Exclusion criteria

congenital malformations, metabolic and genetic disease musculoskeletal system anomaly

Design outcomes

Primary

MeasureTime frameDescription
Test of Infant Motor Profile10 weeksHigh 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.

Secondary

MeasureTime frameDescription
Bayley Scales of Infant and Toddler Development, Third Edition,10 weeksBayley 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).
Infant/Toddler Sensory Profile 210 weeksThe 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).
Infant/Toddler HOME Inventory10 weeksIt 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026