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Hypoxemia in Infants After Palliative Surgery

NCT00327977 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 375

Last updated 2014-12-02

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Disorders

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    lead OTHER

Principal Investigators

  • Martha L Clabby, MD · Children's Healthcare of Atlanta, Sibley Heart Center Cardiology

Eligibility

Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00327977 on ClinicalTrials.gov