Project Early Intervention 2000

Study Overview
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Brief Summary
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The purpose of this study is to examine whether an early intervention program may improve cognitive and behavioral short and longterm outcome in preterm infants.

Detailed Description
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Advances in neonatal medicine has increased the survival of infants with low birth weight. Repeatedly it has been documented an increased prevalence of psychological and medical problems in this group of children. Frequent psychological problems are intellectual disturbances, language delays, behavior problems like ADHD and learning difficulties. Usual medical problems are subnormal growth, various illnesses and neuro-developmental problems. The high prevalence of psychological and medical risks makes this group of children target for follow-up assessments and early intervention. The main aim of the project is to investigate whether sensitizing the parents will reduce the incidence of developmental disturbances in a group of low birth weight infants compared to a control group. The study is carried out as a cooperation between the Departments of child- and adolescent psychiatry and pediatrics of the University Hospital in Tromsoe in Northern - Norway. 140 premature infants with birth weight less than 2000 grams are randomly distributed to an intervention and control group. In addition 70 full term infants are selected to another control. A slightly modified version of The Vermont Intervention Program for Low Birth Weight Infants is applied to the infants in the intervention group, where the parents receive one hour of instruction from a special trained neonatal nurse one hour per day the last week before discharge (infant = 37 weeks G.A.). In addition, the parents receive four home visits during the the three first months after discharge. Psychological and medical assessments are undertaken at ages: 36 weeks G.A., 6 months, 1, 2 3 5 years corrected for prematurity

Official Title
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Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely

Conditions
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Preterm Infants, Parenting Stress

Intervention / Treatment
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* Behavioral: Sensitizing parents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight < 2000 gram Exclusion Criteria: Congenital anomalies Non-Norwegian speaking mother Triplets

Ages Eligible for Study
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Minimum Age: 0 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sensitizing parents|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and behavioral outcome |  |  | 
| Parenting Stress |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental outcome |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, early intervention, outcome, behavioral problems, parenting stress