Very Low Birth Weight Infants
Conditions
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.
Interventions
BEHAVIORALCombined 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
OTHERNo intervention
No intervention
Sponsors
Seoul St. Mary's Hospital
CHA University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bayley Scales of Infant and Toddler Development III, mental developmental index | Corrected age 10 months |
Secondary
| Measure | Time frame |
|---|---|
| CES-D-depression screening tool | Corrected age 2 month & 6 month |
| Maternal attachment | Corrected age 2 month & 6 month |
| Bayley Scales of Infant and Toddler Development III, psychomotor developmental index | Corrected age 10 month |
| Wechsler Intelligence Scale | 8 years of age |
| Conners ADHD/DSM-IV Scales | 8 years of age |
| Temperament scale | Corrected age 8 month |
Countries
South Korea
Outcome results
None listed