Early physiotherapy program for infants in the NICU
Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
This trial will test whether starting physiotherapy early in the NICU helps high-risk newborns (for example, very preterm or medically unstable infants) improve motor, cognitive, and behavioral development.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 28 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Kahramanmaras Sutcu Imam University Academic / other |
| Locations | 1 site (Kahramanmaraş, Onikişubet) |
| Trial ID | NCT07201792 on ClinicalTrials.gov |
What this trial studies
This interventional study delivers a structured early physiotherapy program to infants admitted to a neonatal intensive care unit who are at high environmental or biological risk for neuromotor problems. Eligible infants include those born preterm, with very low birth weight, low Apgar scores, or medical diagnoses such as HIE, intracranial hemorrhage, sepsis, NEC, RDS, BPD, or severe retinopathy of prematurity. The program combines individualized developmental care, positioning and postural control techniques, and family education, and outcomes will be compared with routine NICU care. Primary outcomes focus on motor and neurodevelopmental measures during and after the NICU stay, with attention to feasibility and family-centered aspects.
Who should consider this trial
Good fit: Ideal candidates are NICU infants at biological or environmental risk—such as those born <37 weeks, <1500 g, with 5-minute Apgar <3, or with diagnoses like PVH/ICH, PVL, HIE, sepsis, NEC, RDS, BPD, ROP, or those requiring oxygen or mechanical ventilation.
Not a fit: Infants with major congenital malformations or known metabolic or genetic disorders (for example, spina bifida, Down syndrome, spinal muscular atrophy) who are explicitly excluded are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could improve motor and overall neurodevelopmental outcomes for high-risk NICU infants and support families in ongoing care.
How similar studies have performed: Previous studies of developmental care, kangaroo care, and early physiotherapy in NICUs have shown improvements in infant development, but evidence is mixed and optimal interventions for the highest-risk infants remain uncertain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD. * Newborns receiving oxygen or mechanical ventilation (MV) support. * Infants with a 5-minute Apgar score \<3, \<37 weeks' gestation, \<1500 g preterm, or prematurity due to multiple births. Exclusion Criteria: * Newborns with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
Where this trial is running
Kahramanmaraş, Onikişubet
- Kahramanmaraş Sütçü imam University — Kahramanmaraş, Onikişubet, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: hatice adıgüzel tat, Associate Professor — Kahramanmaras Sutcu Imam University
- Study coordinator: hatice adıgüzel tat, Associate Proffessor
- Email: fzthatis@gmail.com
- Phone: 0903443002647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.