Effects of Early Physiotherapy Program on the Infants in NICU

Kahramanmaraş Sütçü İmam University (KSU)

Status: Enrolling

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

Treatments: Other: Early Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07201792

ACUT PT IN NICU

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 28 to 42 weeks old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

early physiotherapy

Experimental group

Description:

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.

Treatment:

Other: Early Physiotherapy

Standard of care

No Intervention group

Description:

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.