NCT02415530

Early Family Based Intervention in Preterm Infants

Early Family-Based Intervention for Developmental Enforcement of Premature Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Conditions

• Very Low Birth Weight Infants

Interventions

Type	Name	Description
BEHAVIORAL	Combined home visiting and group intervention	home visit includes pre-discharge meeting with parents; education of appropriate feeding, breastfeeding, sleeping, position of baby, defecation, environment for baby care and resuscitation on emergency situation first visit (5 days after discharge); understanding baby's sign check feeding, sleeping, sanitation, defecation, environment second visit (14 days after discharge); understanding baby's sign and baby's development support parents check feeding, sleeping, sanitation, defecation, environment special situation third visit (4 weeks after discharge) understanding baby's sign and baby's development support parents special situation fourth visit (8 weeks after discharge) same as third visit Group intervention for parental support with baby 12 times during corrected age 3\~6 months
OTHER	No intervention	No intervention

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-11-01
• Completion: 2019-02-01
• First posted: 2015-04-14
• Last updated: 2019-04-04

Locations

3 sites across 1 country: South Korea