Ultrasound Screening for Developmental Dysplasia of the Hip in Newborns

March 21, 2013 updated by: Lene Bjerke Laborie, University of Bergen

Ultrasound Screening for Developmental Dysplasia of the Hip in the Neonate: The Effect on Treatment Rate and Prevalence of Late Cases

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11925

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
20 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
treatment rate
Time Frame: 20 years
abduction treatment and/or surgery during infancy, later childhood and skeletal maturity
20 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
avascular necrosis of femoral head (AVN)
Time Frame: 20 years
avascular necrosis of femoral head (AVN) as a complication to treatment
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Child Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Rosendahl, Prof, Pediatric section, Department of Radiology, Haukeland University hospital, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1988

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 1990

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3.2006.144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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