Project Early Intervention 2000

Not Applicable

Completed

• Conditions: Preterm Infants; Parenting Stress

• Registration Number: NCT00222456
• Lead Sponsor: University Hospital of North Norway

Brief Summary

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

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

Study Timeline

• Study Start: 1999-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Last Update Submitted: 2005-09-15
• Study First Posted: 2005-09-22
• Last Update Posted: 2005-09-22
• Study Completion: 2008-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Birth weight < 2000 gram

Exclusion Criteria

• Congenital anomalies
• Non-Norwegian speaking mother
• Triplets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive and behavioral outcome
Parenting Stress

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental outcome

Trial Locations

Locations (1)

Pediatric Dept. University Hospital of North Norway; 🇳🇴 Tromsoe, Norway