Early Family Based Intervention in Preterm Infants

Study Overview
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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.

Official Title
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Early Family-Based Intervention for Developmental Enforcement of Premature Infants

Conditions
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Very Low Birth Weight Infants

Intervention / Treatment
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* Behavioral: Combined home visiting and group intervention
* Other: No intervention


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Term infant control<br>term infant without intervention | Other: No intervention<br>* No intervention<br>|
| Placebo Comparator: VLBW infant control<br>very low birth weight infant without intervention | Other: No intervention<br>* No intervention<br>|
| Experimental: VLBW infant intervention<br>Combined home visiting and group intervention for very low birth weight infant | Behavioral: Combined home visiting and group intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Infant and Toddler Development III, mental developmental index |  | Corrected age 10 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |