NCT07201792

Effects of Early Physiotherapy Program on the Infants in NICU

Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kahramanmaras Sutcu Imam University · Academic / Other
• Sex: All
• Age: 28 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

Summary

High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).

Conditions

• Infants Admitted to Neonatal Units
• NICU
• NICU Infants
• Family Centered Care

Interventions

Type	Name	Description
OTHER	Early Physiotherapy	The early physiotherapy program will begin when the infant is stable and continue until discharge. Depending on the infant's gestational age and respiratory needs, chest physiotherapy, developmental physiotherapy, or both will be administered, if necessary. The early family collaborative physiotherapy program will begin from the first day the infant is stable and parental contact is established, and will consist of routine-based care and family education programs that include therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will be based on a model of goal-oriented active motor learning and sensory strategy development in an enriched environment, and will include family education programs that integrate holding, carrying, and positioning training into daily routines. All parents will participate in the training.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-06-15
• Completion: 2026-08-30
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: Turkey (Türkiye)