Early Family Based Intervention in Preterm Infants

Not Applicable

Completed

• Conditions: Very Low Birth Weight Infants
• Interventions: Other: No intervention; Behavioral: Combined home visiting and group intervention

• 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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-05
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Primary Completion: 2016-11
• Study Completion: 2019-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04

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

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Exclusion Criteria

• major congenital anomaly
• neuromuscular disease
• chromosomal anomaly
• triplets or more multiplets

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLBW infant control	No intervention	very low birth weight infant without intervention
Term infant control	No intervention	term infant without intervention
VLBW infant intervention	Combined home visiting and group intervention	Combined home visiting and group intervention for very low birth weight infant

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)

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