Early Family Based Intervention in Preterm Infants
Not Applicable
Completed
- Conditions
- Very Low Birth Weight Infants
- Registration Number
- NCT02415530
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
This is randomized controlled trial investigating the effect of early intervention in very low birth weight infants after discharge from NICU on neurodevelopmental outcome. Other than control group of VLBW infants, study population includes term infants to compare neurodevelopmental outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- preterm infants < 32 weeks of gestation or 1,500 gm of birth weight
- normal term infants
Exclusion Criteria
- major congenital anomaly
- neuromuscular disease
- chromosomal anomaly
- triplets or more multiplets
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bayley Scales of Infant and Toddler Development III, mental developmental index Corrected age 10 months
- Secondary Outcome Measures
Name Time Method Bayley Scales of Infant and Toddler Development III, psychomotor developmental index Corrected age 10 month Maternal attachment Corrected age 2 month & 6 month Temperament scale Corrected age 8 month Wechsler Intelligence Scale 8 years of age CES-D-depression screening tool Corrected age 2 month & 6 month Conners ADHD/DSM-IV Scales 8 years of age
Trial Locations
- Locations (3)
CHA Gangnam Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
CHA Gangnam Medical Center🇰🇷Seoul, Korea, Republic of