Early Family Based Intervention in Preterm Infants

Seoul National University

Status: Completed

Conditions: Very Low Birth Weight Infants

Treatments: Other: No intervention; Behavioral: Combined home visiting and group intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02415530

1501097642

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups, including a placebo group

Term infant control

Placebo Comparator group

Description:

term infant without intervention

Treatment:

Other: No intervention

VLBW infant control

Placebo Comparator group

Description:

very low birth weight infant without intervention

Treatment:

Other: No intervention

VLBW infant intervention

Experimental group

Description:

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

Treatment:

Behavioral: Combined home visiting and group intervention