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Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

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ClinicalTrials.gov Identifier: NCT01818934
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Sponsor:
Collaborator:
Institute of Child Health
Information provided by (Responsible Party):
Lene Bjerke Laborie, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Hip Dysplasia Procedure: hip ultrasound Not Applicable

Detailed Description:

This is a retrospective registration of a RCT carried out in 1988-90, with a IRB approved follow-up at skeletal maturity carried out in 2007-09. Both the RCT and the follow-up study were carried out in the same institution, by the same PI (Prof. Karen Rosendahl) and her co-workers.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11925 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases
Study Start Date : January 1988
Actual Primary Completion Date : June 1990
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: expert clinical exam only
all babies assigned to this group had expert clinical examination only, no hip ultrasound
Procedure: 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

Active Comparator: 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
Procedure: 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

Active Comparator: universal hip ultrasound screening
All newborns assigned to this arm received hip ultrasound at birth in addition to expert clinical examination
Procedure: 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




Primary Outcome Measures :
  1. prevalence of DDH detected after newborn period [ Time Frame: 20 years ]
    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.


Secondary Outcome Measures :
  1. treatment rate [ Time Frame: 20 years ]
    abduction treatment and/or surgery during infancy, later childhood and skeletal maturity


Other Outcome Measures:
  1. avascular necrosis of femoral head (AVN) [ Time Frame: 20 years ]
    avascular necrosis of femoral head (AVN) as a complication to treatment



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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all babies born at our institution during 1/1988-06/1990

Exclusion Criteria:

  • low birthweight <1500 grams, severe malformations, death within first month

Information from the National Library of Medicine

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): NCT01818934


Locations
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Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
University of Bergen
Institute of Child Health
Investigators
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Principal Investigator: Karen Rosendahl, Prof Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lene Bjerke Laborie, MD, Phd, University of Bergen
ClinicalTrials.gov Identifier: NCT01818934    
Other Study ID Numbers: 3.2006.144
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013
Keywords provided by Lene Bjerke Laborie, University of Bergen:
hip dysplasia
screening
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Hyperplasia
Pathologic Processes
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities