Project Early Intervention 2000
Primary Purpose
Preterm Infants, Parenting Stress
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sensitizing parents
Sponsored by

About this trial
This is an interventional prevention trial for Preterm Infants focused on measuring preterm infants, early intervention, outcome, behavioral problems, parenting stress
Eligibility Criteria
Inclusion Criteria: Birth weight < 2000 gram Exclusion Criteria: Congenital anomalies Non-Norwegian speaking mother Triplets
Sites / Locations
- Pediatric Dept. University Hospital of North Norway
Outcomes
Primary Outcome Measures
Cognitive and behavioral outcome
Parenting Stress
Secondary Outcome Measures
Neurodevelopmental outcome
Full Information
NCT ID
NCT00222456
First Posted
September 15, 2005
Last Updated
September 15, 2005
Sponsor
University Hospital of North Norway
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
1. Study Identification
Unique Protocol Identification Number
NCT00222456
Brief Title
Project Early Intervention 2000
Official Title
Can Early Intervention Prevent Developmental Disturbances/Delays and Improve the Health of Children Born Prematurely
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital of North Norway
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
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Parenting Stress
Keywords
preterm infants, early intervention, outcome, behavioral problems, parenting stress
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Sensitizing parents
Primary Outcome Measure Information:
Title
Cognitive and behavioral outcome
Title
Parenting Stress
Secondary Outcome Measure Information:
Title
Neurodevelopmental outcome
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Birth weight < 2000 gram
Exclusion Criteria:
Congenital anomalies
Non-Norwegian speaking mother
Triplets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ronning, PhD
Organizational Affiliation
University of Tromsoe, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Pediatric Dept. University Hospital of North Norway
City
Tromsoe
ZIP/Postal Code
N-9038
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25888838
Citation
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.
Results Reference
derived
PubMed Identifier
25282345
Citation
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.
Results Reference
derived
PubMed Identifier
25249191
Citation
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.
Results Reference
derived
PubMed Identifier
22184645
Citation
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.
Results Reference
derived
PubMed Identifier
20937650
Citation
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.
Results Reference
derived
Learn more about this trial
Project Early Intervention 2000
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