Effects of Early Physiotherapy Program on the Infants in NICU

NCT ID: NCT07201792

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-08-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Physiotherapy

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.)

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role: lead

Responsible Party

Hatice Adiguzel

Associate Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hatice adıgüzel tat, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

Kahramanmaraş Sütçü imam University

Kahramanmaraş, Onikişubet, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

hatice adıgüzel tat, Associate Proffessor

Role: CONTACT

fzthatis@gmail.com

0903443002647

hatice Adiguzel tat, Associate Proffessor

Role: CONTACT

fzthatis@gmail.com

Facility Contacts

Role: primary

05056491048

Other Identifiers

ACUT PT IN NICU

Identifier Type: -

Identifier Source: org_study_id