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
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|Condition or disease||Intervention/treatment||Phase|
|Preterm Infants Parenting Stress||Behavioral: Sensitizing parents||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Cognitive and behavioral outcome
- Parenting Stress
- Neurodevelopmental outcome
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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|
- Birth weight < 2000 gram
- Congenital anomalies
- Non-Norwegian speaking mother
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
|Pediatric Dept. University Hospital of North Norway|
|Tromsoe, Norway, N-9038|
|Study Chair:||John Ronning, PhD||University of Tromsoe, Norway|
|Other Study ID Numbers:||
NDI 98/2638-2 TFE/- 5
|First Posted:||September 22, 2005 Key Record Dates|
|Last Update Posted:||September 22, 2005|
|Last Verified:||September 2005|
Obstetric Labor, Premature
Obstetric Labor Complications