SAFE Early Intervention for At-Risk Infants (NCT07596147) | Clinical Trial Compass
RecruitingNot Applicable
SAFE Early Intervention for At-Risk Infants
Turkey (Türkiye)34 participantsStarted 2026-02-16
Plain-language summary
This randomized controlled study aims to investigate the effects of the SAFE early intervention approach on upper extremity function, fine motor skills, and developmental outcomes in high-risk infants aged 3-12 months. Thirty high-risk infants admitted to the Developmental Physiotherapy and Pediatric Rehabilitation Unit of Gazi University Faculty of Health Sciences will be randomly assigned to either the SAFE early intervention group or the Neurodevelopmental Treatment (NDT) group.
Infants in the intervention group will receive the SAFE early intervention program for 8 weeks under the supervision of an experienced pediatric physiotherapist. The SAFE approach includes age-appropriate activities focusing on environmental enrichment, promotion of voluntary and goal-directed movements, sensory stimulation, fine motor skill development, postural control, transitional movements, and enhancement of infant-parent interaction through daily routines and home-based activities.
Infants in the control group will receive conventional Neurodevelopmental Treatment (NDT) for 8 weeks. The NDT program includes age-specific activities targeting postural control, muscle tone regulation, facilitation of motor development, hand function, balance, weight transfer, and fine motor skills.
Families will receive education regarding home-based activities and facilitation techniques specific to their infant's developmental needs. Follow-up will include home visits and weekly telephone monitoring to ensure adherence to the intervention program. Assessments will be performed before the intervention and after the 8-week intervention period by a physiotherapist blinded to group allocation.
Who can participate
Age range
3 Months – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants aged between 3 and 12 months corrected age Presence of neurodevelopmental risk factors including perinatal stroke, perinatal asphyxia, hypoxic-ischemic encephalopathy, germinal matrix hemorrhage, intraventricular hemorrhage, periventricular leukomalacia, or prematurity at or below 37 weeks of gestation Admission to the Developmental Pediatrics and Pediatric Physiotherapy and Rehabilitation Unit of Gazi University Faculty of Health Sciences Parent or legal guardian willing to participate and provide written informed consent
Exclusion Criteria:
* Presence of any congenital anomaly Diagnosis of a genetic disorder Any orthopedic problem affecting upper extremity function Families unable to communicate in Turki
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on early intervention for high-risk and preterm infants — can you help me understand whether my baby's specific risk factors or prematurity level match what this study is looking for?
2The trial is measuring hand function using something called the Hand Assessment for Infants and also broader motor development with the Peabody Developmental Motor Scales — does this mean the intervention is mainly focused on motor and hand skills, and would that address the areas you're most concerned about for my baby?
3Since this trial is listed as 'Phase NA,' which I understand often applies to behavioral or therapy-based studies rather than drug trials, what do we actually know about the safety and potential risks of the intervention being tested here?
4What would participating in this trial actually look like week-to-week for us — how often would we need to come in, and is this something that could be done alongside or instead of the early intervention therapies my baby is already receiving or being referred to?
5If we don't join this trial, what standard early intervention options are currently available for my baby, and how do those compare to what this study is offering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hand Assessment for Infants (HAI)
Timeframe: Baseline and after 8 weeks of intervention
2
Peabody Developmental Motor Scales - Second Edition (PDMS-2)
Timeframe: Baseline and after 8 weeks of intervention