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| Name | Class |
|---|---|
| Seoul St. Mary's Hospital | OTHER |
| CHA University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Term infant control | Placebo Comparator | term infant without intervention |
|
| VLBW infant control | Placebo Comparator | very low birth weight infant without intervention |
|
| VLBW infant intervention | Experimental | Combined home visiting and group intervention for very low birth weight infant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined home visiting and group intervention | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Scales of Infant and Toddler Development III, mental developmental index | Corrected age 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Scales of Infant and Toddler Development III, psychomotor developmental index | Corrected age 10 month | |
| CES-D-depression screening tool | Corrected age 2 month & 6 month | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ee-kyung Kim | Seoun National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Gangnam Medical Center | Seoul | South Korea | ||||
| Seoul National University Hospital |
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| No intervention | Other | No intervention |
|
| Maternal attachment |
| Corrected age 2 month & 6 month |
| Temperament scale | Corrected age 8 month |
| Wechsler Intelligence Scale | 8 years of age |
| Conners ADHD/DSM-IV Scales | 8 years of age |
| Seoul |
| South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |