Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-30 @ 3:12 AM
Study NCT ID:
NCT07201792
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Early Physiotherapy Program on the Infants in NICU
Sponsor:
Kahramanmaras Sutcu Imam University
Organization:
Study Overview
Official Title:
Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: