Effects of Early Physiotherapy Program on the Infants in NICU
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Physiotherapy.
- Who it may be relevant to
- Registry conditions: Infants Admitted to Neonatal Units, NICU, NICU Infants, Family Centered Care. Basic parameters: 28 Weeks — 42 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
Overview
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).
Interventions
- 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
Primary outcome measures
- Prechtl's General Movements (GMs) Assessment [Time frame: writhing movement betweeen birth and 8 weeks of age, Fidgety movements between 12 and 20 weeks of age]
- Hammersmith Infant Neurological Examination (HINE) [Time frame: It will be applied at the adjusted 2nd, 3rd, 6th, 9th and 12th months.]
- BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III) [Time frame: at 3, 6 and 12th months]
Secondary outcome measures (3)
- Sociodemographic form [Time frame: first day of the assessment]
- Hammersmith Neonatal Neurological Examination [Time frame: 3 days after birth and corrected postterm 40±2 weeks]
- Body Mass Index (BMI) [Time frame: baseline]
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Kahramanmaraş Sütçü imam University — Kahramanmaraş
Identifiers
NCT: NCT07201792 · ACUT PT IN NICU