Congenital DisordersNCT00229866
Feeding After Neonate Surgery Review
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Disorders
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates who undergo cardiac surgery
Who may be able to join
- Neonates who undergo cardiac surgery
Who cannot join
- -
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: Feeding After Neonatal Surgery Chart Review
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.
Read the detailed description
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.
The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation.
- Conditions
- Congenital Disorders
- Keywords
- newborn, pediatric health, Feeding difficulty, discharge with a NG tube, G-tube placement, Nissen fundoplication
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startAug 2005
- Study completionJun 2006
Why it stopped: sufficient data gathered for study conclusion
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Brian Kogon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229866
- Sponsor's protocol ID
- 04-072
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding After Neonatal Surgery Chart Review
- ClinicalTrials.gov ID
- NCT00229866
- Acronym / sponsor ID
- 04-072
- Conditions
- Congenital Disorders
- Keywords
- newborn, pediatric health, Feeding difficulty, discharge with a NG tube, G-tube placement, Nissen fundoplication
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sufficient data gathered for study conclusion
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Sep 2005 (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.
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.
Detailed description
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.
The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates who undergo cardiac surgery
Key inclusion criteria (1 listed)
- Neonates who undergo cardiac surgery
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: sufficient data gathered for study conclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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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.
Brian Kogon, MD principal investigator
Emory University
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: stopped early, as of the sponsor's last update on 6 Jul 2011. 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 was stopped early (reason given: sufficient data gathered for study conclusion). Results are not available in the source record.
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.
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 6 Jul 2011.