Early Family Based Intervention in Preterm Infants

NCT ID: NCT02415530

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Very Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Term infant control

term infant without intervention

Group Type PLACEBO_COMPARATOR

No intervention

Intervention Type OTHER

No intervention

VLBW infant control

very low birth weight infant without intervention

Group Type PLACEBO_COMPARATOR

No intervention

Intervention Type OTHER

No intervention

VLBW infant intervention

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

Group Type EXPERIMENTAL

Combined home visiting and group intervention

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role collaborator

CHA University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ee-Kyung Kim

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ee-kyung Kim

Role: PRINCIPAL_INVESTIGATOR

Seoun National University Hospital

Locations

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CHA Gangnam Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1501097642

Identifier Type: -

Identifier Source: org_study_id

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