Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns
1 other identifier
interventional
11,925
1 country
1
Brief Summary
The aim of the randomized controlled trial was to determine whether the addition of a general or of a selective ultrasound screening program resulted in more appropriate criteria for treatment and a reduced prevalence of late DDH compared with clinical examination alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1988
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1988
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1990
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 27, 2013
CompletedMarch 27, 2013
March 1, 2013
2.4 years
March 21, 2013
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prevalence of DDH detected after newborn period
prevalence of late cases of DDH, detected after newborn period (after first month of age, including in childhood as assessed in original RCT during 1988-90, with a minimum follow-up time of 27 months, and also at skeletal maturity, as assessed in follow-up study during 2007-09.
20 years
Secondary Outcomes (1)
treatment rate
20 years
Other Outcomes (1)
avascular necrosis of femoral head (AVN)
20 years
Study Arms (3)
expert clinical exam only
ACTIVE COMPARATORall babies assigned to this group had expert clinical examination only, no hip ultrasound
selective hip ultrasound screening
ACTIVE COMPARATORall 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
universal hip ultrasound screening
ACTIVE COMPARATORAll newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
Interventions
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
You may qualify if:
- all babies born at our institution during 1/1988-06/1990
You may not qualify if:
- low birthweight \<1500 grams, severe malformations, death within first month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- Institute of Child Healthcollaborator
Study Sites (1)
Haukeland University Hospital
Bergen, Bergen, 5021, Norway
Related Publications (7)
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.
PMID: 8008537RESULTLaborie 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.
PMID: 23354528RESULTLaborie 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.
PMID: 21613440RESULTLaborie 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.
PMID: 23412733RESULTEngesaeter 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.
PMID: 21946945RESULTEngesaeter 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.
PMID: 23365042RESULTLaborie 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.
PMID: 23958776DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Rosendahl, Prof
Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Phd
Study Record Dates
First Submitted
March 21, 2013
First Posted
March 27, 2013
Study Start
January 1, 1988
Primary Completion
June 1, 1990
Study Completion
March 1, 2009
Last Updated
March 27, 2013
Record last verified: 2013-03