NCT00327977|Completed
Hypoxemia in Infants After Palliative Surgery
A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
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A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
Sponsor study identifier
observational
375
1 country
1
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Congenital heart disease is a major cause of morbidity and mortality in infants. Many cardiac defects require surgical palliation or repair in the newborn period. The effects of chronic hypoxia on growth and development are unclear. Infants with very severe cardiac defects may undergo surgery in infancy, but often this cardiac surgery can provide only palliation, not correction. As a result, these infants are exposed to a physiology of chronic hypoxia during the neonatal period through infancy, a critical period of growth and development. The optimal oxygen saturations for infants with palliated cardiac defects is unknown. The purpose of this study is to analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference during the first three years of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
May 18, 2006
Actual (reported)May 19, 2006
Actual (reported)February 2011
Actual (reported)February 2011
Actual (reported)Analyze the growth and development of infants with post-surgical palliation in infancy and assess variations in oxygenation saturations and hemodynamics as they relate to weight gain, linear growth and increases in head circumference.
Ongoing data analysis of risk factors for death in the high risk population has revealed that some aspects of the clinical course of these patients which are new to the field. Episodes of decomposition may not have been sudden as previously thought, but may have been preceded by some mild signs of change in cardiovascular status. This may in fact have led to changes in clinical course that were undetected because this was a new clinical finding.
5 years
patients'charts only from Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Martha L Clabby, MD
Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
375 participants (actual enrollment reported by the registry).
First Submitted
May 18, 2006
First Posted
May 19, 2006
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
December 2, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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