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Newborn Screening for Critical Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT01765205
Recruitment Status : Completed
First Posted : January 10, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date December 6, 2012
First Posted Date January 10, 2013
Last Update Posted Date March 14, 2014
Study Start Date March 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2013)
To measure the oxygen saturation using pulse oximetry. [ Time Frame: Baseline ]
The oxygen saturation will be measured by pulse oximetry on an infant's skin on the forehead and thigh. These two numbers will be recorded as whole numbers on the machine and will be compared to both groups of infants.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01765205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Newborn Screening for Critical Congenital Heart Disease
Official Title The Efficacy of Newborn Screening for Critical Congenital Heart Disease
Brief Summary Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.
Detailed Description This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy newborns and newborns diagnosed with congenital cardiovascular malformations
Condition Congenital Cardiovascular Malformation
Intervention Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.
Other Name: Healthy Newborns with Pulse oximetry
Study Groups/Cohorts
  • Newborns with Pulse oximetry
    Up to 50 healthy newborn participants will receive 15 minutes of pulse oximetry to determine the effectiveness of measuring somatic oxygen saturation.
    Intervention: Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
  • CHD infant with pulse oximetry
    Up to 10 infants diagnosed with congenital heart disease will receive 15 minutes of pulse oximetry using the INVOS Cerebral/Somatic Oximeter to determine the effectiveness of measuring somatic oxygen saturation.
    Intervention: Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 13, 2014)
20
Original Estimated Enrollment
 (submitted: January 8, 2013)
60
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female subjects aged 12 hours -2 weeks.
  • Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
  • Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)

Exclusion Criteria:

  • Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Weeks   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01765205
Other Study ID Numbers IRB 118-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Barry J Byrne, MD, PhD University of Florida
PRS Account University of Florida
Verification Date March 2014