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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Kahramanmaraş Sütçü imam University
RECRUITING
Kahramanmaraş
Contact Information
Primary
hatice adıgüzel tat, Associate Proffessor
fzthatis@gmail.com
0903443002647
Backup
hatice Adiguzel tat, Associate Proffessor
fzthatis@gmail.com
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 100
Treatments
Experimental: early physiotherapy
A physiotherapy program tailored to the needs of infants from families who volunteer will be implemented until and including discharge. Parents of all infants discharged from the NICU will receive advice on holding, carrying, and positioning.
No_intervention: Standard of care
Infants from families who cannot attend physiotherapy for any reason (those living outside the province, those who cannot attend treatment sessions at the same frequency, working parents) will constitute the control group if they can come to the evaluations.
Related Therapeutic Areas
Sponsors
Leads: Kahramanmaras Sutcu Imam University

This content was sourced from clinicaltrials.gov