Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns
NCT ID: NCT01818934
Last Updated: 2013-03-27
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
11925 participants
INTERVENTIONAL
1988-01-31
2009-03-31
Brief Summary
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Detailed Description
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Detailed information is published in the following paper:
Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics 1994;94:47-52.
A sample of the initial RCT was invited for a maturity review/follow-up at skeletal maturity.
The follow-up at skeletal maturity is called:
Radiological indices of hip dysplasia and osteoarthritis at skeletal maturity in the Bergen Birth Cohort. Associations with neonatal hip dysplasia, childhood growth and genetic predisposition
and is included in the approval by the Regional Ethical Committee for Medical and Health Research (No 3.2006.144). All participants of the follow-up study gave written informed consent according to the 1964 Declaration of Helsinki.
The follow-up had the following main aims:
1\) estimate the prevalence of radiologically defined hip dysplasia, femoroacetabular impingement and osteoarthritis assessed at skeletal maturity 2)report the frequency of 4 longitudinal dysplasia phenotypes based on sonographic assessments in the newborn and radiological assessments at skeletal maturity 3)investigate associations of dysplasia as defined in 1 and 2 above in univariate and multivariate models with clinically assessed hip joint mobility/joint hypermobility, weight, height and body mass index (BMI) at age 18/19 years, prepubertal weight, height and BMI trajectories using data from child health records, first degree family history of hip dysplasia with or without hip arthroplasty, perinatal factors, measures of OA including minimum joint space, acetabular depth ratio and reported hip pain 5) establish a genetic resource by obtaining and archiving salivary DNA samples.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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expert clinical exam only
all babies assigned to this group had expert clinical examination only, no hip ultrasound
hip ultrasound
Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
selective hip ultrasound screening
all children classified at increased risk, based on clinical findings and/or risk factors (breech presentation, family history, foot deformity)received a hip ultrasound at birth, in addition to expert clinical screening
hip ultrasound
Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
universal hip ultrasound screening
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
hip ultrasound
Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
Interventions
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hip ultrasound
Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
Yes
Sponsors
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Institute of Child Health
OTHER
University of Bergen
OTHER
Responsible Party
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Lene Bjerke Laborie
MD, Phd
Principal Investigators
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Karen Rosendahl, Prof
Role: PRINCIPAL_INVESTIGATOR
Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen
Locations
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Haukeland University Hospital
Bergen, Bergen, Norway
Countries
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References
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Rosendahl K, Markestad T, Lie RT. Ultrasound screening for developmental dysplasia of the hip in the neonate: the effect on treatment rate and prevalence of late cases. Pediatrics. 1994 Jul;94(1):47-52.
Laborie LB, Engesaeter IO, Lehmann TG, Sera F, Dezateux C, Engesaeter LB, Rosendahl K. Radiographic measurements of hip dysplasia at skeletal maturity--new reference intervals based on 2,038 19-year-old Norwegians. Skeletal Radiol. 2013 Jul;42(7):925-35. doi: 10.1007/s00256-013-1574-y. Epub 2013 Jan 27.
Laborie LB, Lehmann TG, Engesaeter IO, Eastwood DM, Engesaeter LB, Rosendahl K. Prevalence of radiographic findings thought to be associated with femoroacetabular impingement in a population-based cohort of 2081 healthy young adults. Radiology. 2011 Aug;260(2):494-502. doi: 10.1148/radiol.11102354. Epub 2011 May 25.
Laborie LB, Lehmann TG, Engesaeter IO, Engesaeter LB, Rosendahl K. Is a positive femoroacetabular impingement test a common finding in healthy young adults? Clin Orthop Relat Res. 2013 Jul;471(7):2267-77. doi: 10.1007/s11999-013-2850-9. Epub 2013 Feb 15.
Engesaeter IO, Laborie LB, Lehmann TG, Sera F, Fevang J, Pedersen D, Morcuende J, Lie SA, Engesaeter LB, Rosendahl K. Radiological findings for hip dysplasia at skeletal maturity. Validation of digital and manual measurement techniques. Skeletal Radiol. 2012 Jul;41(7):775-85. doi: 10.1007/s00256-011-1283-3. Epub 2011 Sep 25.
Engesaeter IO, Laborie LB, Lehmann TG, Fevang JM, Lie SA, Engesaeter LB, Rosendahl K. Prevalence of radiographic findings associated with hip dysplasia in a population-based cohort of 2081 19-year-old Norwegians. Bone Joint J. 2013 Feb;95-B(2):279-85. doi: 10.1302/0301-620X.95B2.30744.
Laborie LB, Engesaeter IO, Lehmann TG, Eastwood DM, Engesaeter LB, Rosendahl K. Screening strategies for hip dysplasia: long-term outcome of a randomized controlled trial. Pediatrics. 2013 Sep;132(3):492-501. doi: 10.1542/peds.2013-0911. Epub 2013 Aug 19.
Other Identifiers
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3.2006.144
Identifier Type: -
Identifier Source: org_study_id
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