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Project Early Intervention 2000

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ClinicalTrials.gov Identifier: NCT00222456
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborators:
The Research Council of Norway
Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
The Northern Norway Health Authority
University of Tromso
Information provided by:
University Hospital of North Norway

Study Description
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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.

Condition or disease Intervention/treatment Phase
Preterm Infants Parenting Stress Behavioral: Sensitizing parents Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
Study Start Date : March 1999
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Cognitive and behavioral outcome
  2. Parenting Stress

Secondary Outcome Measures :
  1. Neurodevelopmental outcome

Eligibility Criteria
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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Birth weight < 2000 gram

Exclusion Criteria:

  • Congenital anomalies
  • Non-Norwegian speaking mother
  • Triplets
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222456


Locations
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Norway
Pediatric Dept. University Hospital of North Norway
Tromsoe, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
The Research Council of Norway
Norwegian Council for Mental Health
Norwegian Foundation for Health and Rehabilitation
The Northern Norway Health Authority
University of Tromso
Investigators
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Study Chair: John Ronning, PhD University of Tromsoe, Norway
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00222456    
Other Study ID Numbers: SFP 46-04
NSD-codes: MN990199
NFR-number: 132506/320
NDI 98/2638-2 TFE/- 5
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005
Keywords provided by University Hospital of North Norway:
preterm infants
early intervention
outcome
behavioral problems
parenting stress
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications