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Completed

NCT Number: NCT00222456

Project Early Intervention 2000

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.

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Key information

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Dept. University Hospital of North Norway

Tromsø, N-9038, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Birth weight < 2000 gram

Exclusion criteria

  • Congenital anomalies
  • Non-Norwegian speaking mother
  • Triplets

Treatment and study plan

Sensitizing parents

Behavioral

Primary outcomes

  1. Cognitive and behavioral outcome

  2. Parenting Stress

Secondary outcomes

  1. Neurodevelopmental outcome

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Norwegian Council for Mental Health
  • Norwegian Foundation for Health and Rehabilitation
  • The Northern Norway Health Authority
  • The Research Council of Norway
  • University of Tromso

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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