Congenital DisordersNCT00327977
Hypoxemia in Infants After Palliative Surgery
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: patients'charts only from Children's Healthcare of Atlanta
Who may be able to join
- 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
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
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.
Read the detailed 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.
- Conditions
- Congenital Disorders
- Keywords
- hypoxemia, palliative neonatal surgery
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startJan 2001
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha L Clabby, MD, Principal investigator, Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327977
- Sponsor's protocol ID
- 06-128
- Status last verified
- Nov 2014
- First submitted
- 18 May 2006
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Hypoxemia in Infants After Palliative Neonatal Surgery for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00327977
- Acronym / sponsor ID
- 06-128
- Conditions
- Congenital Disorders
- Keywords
- hypoxemia, palliative neonatal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients'charts only from Children's Healthcare of Atlanta
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha L Clabby, MD principal investigator
Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.