Early Family Based Intervention in Preterm Infants

April 3, 2019 updated by: Ee-Kyung Kim, Seoul National University Hospital

Early Family-Based Intervention for Developmental Enforcement of Premature 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Seoul st. mary's hospital
      • Seoul, Korea, Republic of
        • CHA Gangnam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Term infant control
term infant without intervention
Other: No intervention
No intervention
PLACEBO_COMPARATOR: VLBW infant control
very low birth weight infant without intervention
Other: No intervention
No intervention
EXPERIMENTAL: VLBW infant intervention
Combined home visiting and group intervention for very low birth weight infant
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bayley Scales of Infant and Toddler Development III, mental developmental index
Time Frame: Corrected age 10 months
Corrected age 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
Time Frame: Corrected age 10 month
Corrected age 10 month
CES-D-depression screening tool
Time Frame: Corrected age 2 month & 6 month
Corrected age 2 month & 6 month
Maternal attachment
Time Frame: Corrected age 2 month & 6 month
Corrected age 2 month & 6 month
Temperament scale
Time Frame: Corrected age 8 month
Corrected age 8 month
Wechsler Intelligence Scale
Time Frame: 8 years of age
8 years of age
Conners ADHD/DSM-IV Scales
Time Frame: 8 years of age
8 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul St. Mary's Hospital
CHA University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

April 5, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (ESTIMATE)

April 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1501097642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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