Early Family-Based Intervention for Developmental Enforcement of Premature Infants

Seoul National University Hospital3 sites in 1 country150 target enrollmentMarch 2015

ConditionsVery Low Birth Weight Infants

Overview

Phase: N/A
Intervention: Not specified
Conditions: Very Low Birth Weight Infants
Sponsor: Seoul National University Hospital
Enrollment: 150
Locations: 3
Primary Endpoint: Bayley Scales of Infant and Toddler Development III, mental developmental index
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

February 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Ee-Kyung Kim

Clinical associate professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bayley Scales of Infant and Toddler Development III, mental developmental index

Time Frame: Corrected age 10 months

Secondary Outcomes

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)