Early Family Based Intervention in Preterm Infants

NCT02415530 | Completed DMC

• 1 other identifier: 1501097642
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Very Low Birth Weight Infants

Outcome Measures

Primary Outcomes (1)

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

  Corrected age 10 months

Secondary Outcomes (6)

• Bayley Scales of Infant and Toddler Development III, psychomotor developmental index

  Corrected age 10 month

• CES-D-depression screening tool

  Corrected age 2 month & 6 month

• Maternal attachment

  Corrected age 2 month & 6 month

• Temperament scale

  Corrected age 8 month

• Wechsler Intelligence Scale

  8 years of age

Study Arms (3)

Term infant control

PLACEBO COMPARATOR

term infant without intervention

Other: No intervention

VLBW infant control

PLACEBO COMPARATOR

very low birth weight infant without intervention

Other: No intervention

VLBW infant intervention

EXPERIMENTAL

Combined home visiting and group intervention for very low birth weight infant

Behavioral: Combined home visiting and group intervention

Interventions

Combined home visiting and group intervention BEHAVIORAL

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

VLBW infant intervention

No intervention OTHER

No intervention

Term infant control; VLBW infant control

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants \< 32 weeks of gestation or 1,500 gm of birth weight
• normal term infants

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul St. Mary's Hospital: collaborator
• CHA University: collaborator

Study Sites (3)

CHA Gangnam Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Study Officials

• Ee-kyung Kim

  Seoun National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: April 5, 2015
• First Posted: April 14, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

KR (3)