Actively Recruiting
Effects of Early Physiotherapy Program on Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
Led by Kahramanmaras Sutcu Imam University · Updated on 2025-10-01
100
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying infants at high risk for neuromotor developmental problems, including premature babies born before 37 weeks, low birth weight babies, and those with developmental delays due to various causes. The study aims to evaluate family-based early physiotherapy approaches applied in the neonatal intensive care unit (NICU) and their effects on motor, cognitive, language development, and overall developmental outcomes at term age and during the first year of life. The study compares an early physiotherapy program tailored to infant needs and involving family education against standard care. The program starts once the infant is stable and continues until discharge, including chest physiotherapy, developmental physiotherapy, or both as needed. Parents receive training on therapeutic holding, carrying, positioning, and sucking facilitation to support motor learning and sensory development in an enriched environment. The control group consists of infants whose families cannot attend physiotherapy but can come for evaluations. Participants undergo several assessments including Prechtl's General Movements Assessment between birth and 20 weeks, Hammersmith Infant Neurological Examination at adjusted 2, 3, 6, 9, and 12 months, and the BAYLEY-III Infant and Child Development Assessment Scale at 3, 6, and 12 months. Additional evaluations include sociodemographic forms, neonatal neurological exams, and BMI measurements. The study monitors developmental progress and safety through these repeated evaluations over the infant's first year.
CONDITIONS
Brief Title
Effects of Early Physiotherapy Program on the Infants in NICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborns diagnosed with periventricular hemorrhage, intracranial hemorrhage, cystic periventricular leukomalacia, hypoxic-ischemic encephalopathy, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis, retinopathy of prematurity, respiratory distress syndrome, or bronchopulmonary dysplasia
- Newborns receiving oxygen or mechanical ventilation support
- Infants with a 5-minute Apgar score less than 3
- Infants born before 37 weeks of gestation
- Infants weighing less than 1500 grams at birth
- Infants born prematurely due to multiple births
You will not qualify if you...
- Newborns with congenital malformations such as spina bifida, congenital muscular torticollis, or arthrogryposis multiplex congenita
- Babies diagnosed with metabolic or genetic diseases such as Down syndrome, spinal muscular atrophy, or Duchenne muscular dystrophy
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From the first day the infant is stable until discharge from the NICU
Participants receive an early physiotherapy program tailored to their needs starting when the infant is stable and continuing until discharge. This includes chest and developmental physiotherapy as needed, along with family education on therapeutic holding, carrying, positioning, and sucking facilitation.
Regular physiotherapy sessions and family education during hospitalization
Duration - Up to 12 months after discharge
Participants undergo developmental assessments using Prechtl's General Movements Assessment, Hammersmith Infant Neurological Examination, and BAYLEY-III Infant and Child Development Assessment Scale at multiple time points after discharge.
Assessments at 2, 3, 6, 9, and 12 months adjusted age with additional visits at 3, 6, and 12 months for developmental scales
Trial Site Locations
Total: 1 location
1
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubet, Turkey (Türkiye), 46100
Actively Recruiting
Research Team
H
hatice adıgüzel tat, Associate Proffessor
H
hatice Adiguzel tat, Associate Proffessor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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