Project Early Intervention 2000

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222456
• Other study ID #: SFP 46-04
• Secondary ID: NSD-codes: MN990
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: September 15, 2005
• Start date: March 1999
• Est. completion date: September 2008

Study information

• Verified date: September 2005
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Birth weight < 2000 gram

Exclusion Criteria:

• Congenital anomalies

• Non-Norwegian speaking mother

• Triplets

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parenting Stress
• Preterm Infants

Intervention

Behavioral:
• Sensitizing parents

Locations

Country	Name	City	State
Norway	Pediatric Dept. University Hospital of North Norway	Tromsoe

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital of North Norway	Norwegian Council for Mental Health, Norwegian Foundation for Health and Rehabilitation, The Northern Norway Health Authority, The Research Council of Norway, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive and behavioral outcome
Primary	Parenting Stress
Secondary	Neurodevelopmental outcome