Early Family Based Intervention in Preterm Infants

Very Low Birth Weight Infants Clinical Trial

Official title:

Early Family-Based Intervention for Developmental Enforcement of Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415530
• Other study ID #: 1501097642
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 2019

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2019
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infants

Intervention

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

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	CHA University, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bayley Scales of Infant and Toddler Development III, mental developmental index		Corrected age 10 months
Secondary	Bayley Scales of Infant and Toddler Development III, psychomotor developmental index		Corrected age 10 month
Secondary	CES-D-depression screening tool		Corrected age 2 month & 6 month
Secondary	Maternal attachment		Corrected age 2 month & 6 month
Secondary	Temperament scale		Corrected age 8 month
Secondary	Wechsler Intelligence Scale		8 years of age
Secondary	Conners ADHD/DSM-IV Scales		8 years of age