Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
1999-03-31
2008-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Sensitizing parents
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-Norwegian speaking mother
* Triplets
0 Years
ALL
Yes
Sponsors
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The Research Council of Norway
OTHER
Norwegian Council for Mental Health
OTHER
Norwegian Foundation for Health and Rehabilitation
OTHER
The Northern Norway Health Authority
UNKNOWN
University of Tromso
OTHER
University Hospital of North Norway
OTHER
Principal Investigators
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John Ronning, PhD
Role: STUDY_CHAIR
University of Tromsoe, Norway
Locations
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Pediatric Dept. University Hospital of North Norway
Tromsø, , Norway
Countries
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References
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Landsem IP, Handegard BH, Ulvund SE, Kaaresen PI, Ronning JA. Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial. Health Qual Life Outcomes. 2015 Feb 22;13:25. doi: 10.1186/s12955-015-0221-9.
Landsem IP, Handegard BH, Tunby J, Ulvund SE, Ronning JA. Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial. Trials. 2014 Oct 4;15:387. doi: 10.1186/1745-6215-15-387.
Hauglann L, Handegaard BH, Ulvund SE, Nordhov M, Ronning JA, Kaaresen PI. Cognitive outcome of early intervention in preterms at 7 and 9 years of age: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F11-6. doi: 10.1136/archdischild-2014-306496. Epub 2014 Sep 23.
Nordhov SM, Ronning JA, Ulvund SE, Dahl LB, Kaaresen PI. Early intervention improves behavioral outcomes for preterm infants: randomized controlled trial. Pediatrics. 2012 Jan;129(1):e9-e16. doi: 10.1542/peds.2011-0248. Epub 2011 Dec 19.
Nordhov SM, Ronning JA, Dahl LB, Ulvund SE, Tunby J, Kaaresen PI. Early intervention improves cognitive outcomes for preterm infants: randomized controlled trial. Pediatrics. 2010 Nov;126(5):e1088-94. doi: 10.1542/peds.2010-0778. Epub 2010 Oct 11.
Other Identifiers
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NSD-codes: MN990199
Identifier Type: -
Identifier Source: secondary_id
NFR-number: 132506/320
Identifier Type: -
Identifier Source: secondary_id
NDI 98/2638-2 TFE/- 5
Identifier Type: -
Identifier Source: secondary_id
SFP 46-04
Identifier Type: -
Identifier Source: org_study_id