Status:
COMPLETED
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
Lead Sponsor:
Sanko University
Conditions:
Cerebral Palsy
Infant, Newborn, Disease
Eligibility:
All Genders
24-40 years
Phase:
NA
Brief Summary
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infan...
Detailed Description
High-risk infants who are thought to have developmental disorders need early intervention, but it is not yet unknown which interventions are more effective. In the literature, although interventions a...
Eligibility Criteria
Inclusion
- Periventricular hemorrhage, patients with intracranial hemorrhage grade 2, 3, 4, cystic periventricular leukomalacia, Stage 3 hypoxic ischemic encephalopathy, Neonatal bilirubin encephalopathy (kernicterius), perinatal stroke, perinatal asphyxia, babies with hydrocephalus
- Chronic pulmonary disease Infants with dysplasia and long-term O₂ support
- Preterm infants with sepsis, necrotizing enterocolitis (NEC), infantile apnea, cerebral malformation due to gram negative bacteria
- Patients with a low Apgar score of 5 minutes (3 and less), multiple births (twins, triplets) diagnosed with intrauterine growth retardation, preterm infants with premature retinopathy (ROP)
- Infants with prolonged severe hypoglycemia and hypocalcemia
- Surgical conditions such as diaphragmatic hernia or tracheoesophageal fistula
- Infants younger than gestational age (Small for Gestational Age, SGA, smaller than 3rd percentile) or older than gestational age (Large for Gestational Age, LGA, greater than 97th percentile)
- Babies receiving mechanical ventilation for more than 24 hours
- Babies less than 32 weeks of gestation and born under 1500 g
Exclusion
- Infants with congenital malformation (Spina Bifida, Congenital Muscular Torticollis, Arthrogriposis Multiplex Congenita etc.)
- Infants diagnosed with metabolic and genetic diseases (Down Syndrome, Spinal Muscular Atrophy, Duchenne Muscular Dystrophy etc.)
- Infants still intubated and mechanical ventilator dependent at postterm 3 months
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04035291
Start Date
August 1 2019
End Date
July 30 2020
Last Update
April 13 2021
Active Locations (1)
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1
Sanko University
Gaziantep, Şehitkamil, Turkey (Türkiye), 27090