Hypoxemia in Infants After Palliative Surgery

NCT00327977 | Completed

• 1 other identifier: 06-128
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hypoxemia; palliative neonatal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

patients'charts only from Children's Healthcare of Atlanta

You may qualify if:

• patient charts from 01/01/2001 through 03/31/2006 seen at Children's Healthcare of Atlanta or Sibley Heart Center Cardiology for surgical palliation for Hypoplastic left heart syndrome or surgical palliation for Pulmonary atresia or surgical palliation for Severe pulmonary stenosis

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha L Clabby, MD

  Children's Healthcare of Atlanta, Sibley Heart Center Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: January 1, 2001
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (1)