Back to resultsEarly Family Based Intervention in Preterm Infants
Primary Purpose
Very Low Birth Weight Infants
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Combined home visiting and group intervention
No intervention
Sponsored by
About this trial
This is an interventional health services research trial for Very Low Birth Weight Infants
Eligibility Criteria
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
Sites / Locations
- CHA Gangnam Medical Center
- Seoul National University Hospital
- Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Placebo Comparator
Experimental
Arm Label
Term infant control
VLBW infant control
VLBW infant intervention
Arm Description
term infant without intervention
very low birth weight infant without intervention
Combined home visiting and group intervention for very low birth weight infant
Outcomes
Primary Outcome Measures
Bayley Scales of Infant and Toddler Development III, mental developmental index
Secondary Outcome Measures
Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
CES-D-depression screening tool
Maternal attachment
Temperament scale
Wechsler Intelligence Scale
Conners ADHD/DSM-IV Scales
Full Information
NCT ID
NCT02415530
First Posted
April 5, 2015
Last Updated
April 3, 2019
Sponsor
Seoul National University Hospital
Collaborators
Seoul St. Mary's Hospital, CHA University
1. Study Identification
Unique Protocol Identification Number
NCT02415530
Brief Title
Early Family Based Intervention in Preterm Infants
Official Title
Early Family-Based Intervention for Developmental Enforcement of Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul St. Mary's Hospital, CHA University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infants
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Term infant control
Arm Type
Placebo Comparator
Arm Description
term infant without intervention
Arm Title
VLBW infant control
Arm Type
Placebo Comparator
Arm Description
very low birth weight infant without intervention
Arm Title
VLBW infant intervention
Arm Type
Experimental
Arm Description
Combined home visiting and group intervention for very low birth weight infant
Intervention Type
Behavioral
Intervention Name(s)
Combined home visiting and group intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Bayley Scales of Infant and Toddler Development III, mental developmental index
Time Frame
Corrected age 10 months
Secondary Outcome Measure Information:
Title
Bayley Scales of Infant and Toddler Development III, psychomotor developmental index
Time Frame
Corrected age 10 month
Title
CES-D-depression screening tool
Time Frame
Corrected age 2 month & 6 month
Title
Maternal attachment
Time Frame
Corrected age 2 month & 6 month
Title
Temperament scale
Time Frame
Corrected age 8 month
Title
Wechsler Intelligence Scale
Time Frame
8 years of age
Title
Conners ADHD/DSM-IV Scales
Time Frame
8 years of age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ee-kyung Kim
Organizational Affiliation
Seoun National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Gangnam Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Early Family Based Intervention in Preterm Infants
We'll reach out to this number within 24 hrs