Project Early Intervention 2000

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00222456
Study type	Interventional
Source	University Hospital of North Norway
Contact
Status	Completed
Phase	N/A
Start date	March 1999
Completion date	September 2008

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.