Skip to main content
OpenTrials
Completed

NCT Number: NCT02415530

Early Family Based Intervention in Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Very Low Birth Weight Infants

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHA Gangnam Medical Center, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

No intervention

Other

No intervention

Primary outcomes

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

    Time frame: Corrected age 10 months

Secondary outcomes

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

    Time frame: Corrected age 10 month

  2. CES-D-depression screening tool

    Time frame: Corrected age 2 month & 6 month

  3. Maternal attachment

    Time frame: Corrected age 2 month & 6 month

  4. Temperament scale

    Time frame: Corrected age 8 month

  5. Wechsler Intelligence Scale

    Time frame: 8 years of age

  6. Conners ADHD/DSM-IV Scales

    Time frame: 8 years of age

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • CHA University
  • Seoul St. Mary's Hospital

Registry information

Official study title

Early Family-Based Intervention for Developmental Enforcement of Premature Infants

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Apr 14, 2015
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.