Hypoxemia in Infants After Palliative Surgery

Congenital Disorders Clinical Trial

Official title:

A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327977
• Other study ID #: 06-128
• Status: Completed
• Phase: N/A
• First received: May 18, 2006
• Last updated: November 25, 2014
• Start date: January 2001
• Est. completion date: February 2011

Study information

• Verified date: November 2014
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

We wish to do a retrospective review of clinical data on infants who have undergone surgical palliation for the following cardiac defects over the past five years (from January 1, 2001 through March 31, 2006):

Hypoplastic left heart syndrome Pulmonary atresia Severe pulmonary stenosis.

The patient charts, between the dates of 01.01.2001and 03.31.2006, will be reviewed from Children's Healthcare of Atlanta, Egleston Hospital and the Sibley Heart Center Cardiology clinics of Children's Healthcare of Atlanta.

We will review approximately 180 charts.

We will collect the following information on each patient:

Medical Record Number Account number Dates of admission, discharge, treatment or death, date of birth Information regarding cardiac signs and symptoms, medication information Age, weight , diagnoses and results of imaging studies Clinic visit information during routine follow up appointments such as weight, length, head circumference, oxygen saturations, vital signs, medications, diet, blood pressures, symptoms,blood tests, chest x-ray findings, dates and types of procedures Readmissions, feeding regimen, cardiac catheterization data, surgical data Parent histories of developmental milestones, physical therapy and speech therapy consultations, feeding history, evaluations of swallowing function Airway symptoms Noncardiac procedures and noncardiac medical problems Family history and social history as it relates to care of the infants at home, complications of medical or surgical treatment and cerebral oximetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Those who do not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No