Congenital DisordersNCT00257517
Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
An observational study of Congenital Disorders, run by Emory University at 1 site in United States.
Trial summary
This study will assess 75-100 patients for feeding issues following surgery for single ventricle. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Congenital Disorders
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2010
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Study population: hypoplastic left heart syndrome
Who may be able to join
- Single ventricle patients who have received the Norwood Stage I operation.
Who cannot join
- Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis [NEC] or other gastrointestinal [GI] anomalies)
- Prematurity less than 37 weeks
- Infants greater than 30 days of age at Stage I palliation
- Parents who cannot read or understand questionnaires administered as a part of the study.
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: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
This study will assess 75-100 patients for feeding issues following surgery for single ventricle.
Read the detailed description
We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.
If subjects take part in this study, the following will happen:
- Prior to discharge, the parent/guardian will be given a home feeding log and
- Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
- The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
- The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:
- First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
- Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
- Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.
It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.
The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.
- Conditions
- Congenital Disorders
- Keywords
- Congenital heart disease, Single ventricle, Infant feeding
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Heart Defects, Congenital, Univentricular Heart
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2010
- Study completionJun 2010
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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha L. Clabby, MD, Emory University
- Investigators
- Martha Clabby, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257517
- Sponsor's protocol ID
- IRB00021873
- Status last verified
- Feb 2014
- First submitted
- 22 Nov 2005
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle
- ClinicalTrials.gov ID
- NCT00257517
- Acronym / sponsor ID
- IRB00021873
- Conditions
- Congenital Disorders
- Keywords
- Congenital heart disease, Single ventricle, Infant feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Nov 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.
This study will assess 75-100 patients for feeding issues following surgery for single ventricle.
Detailed description
We wish to consent 75-100 subjects at Children's Healthcare of Atlanta.
If subjects take part in this study, the following will happen:
- Prior to discharge, the parent/guardian will be given a home feeding log and
- Parents will bring the feeding log to regularly scheduled clinic visits. Clinic staff will also weigh the child and measure head circumference at each clinic visit.
- The investigators will look at the child's medical record to obtain other information including diagnosis, surgery, oxygen saturation levels and medications.
- The parent/guardian will be asked to fill out a questionnaire about their stress and uncertainty caring for their baby after heart surgery. They will be asked to fill out the same questionnaire 3 times:
- First time will be before they leave the hospital after the baby's surgery, while still a patient on the Cardiac Step Down Unit (CSU).
- Second time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 4 weeks.
- Third time will be at the Sibley Heart Center Cardiology clinic after they have been home for approximately 12 weeks or at the time of the routine cardiac cath prior to their second stage surgery.
It should take about 15 minutes to fill out the questionnaire. The questionnaire is the only research procedure.
The data from the feeding log and clinic visits will be submitted to Cincinnati Children's, the primary site for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- hypoplastic left heart syndrome
Key inclusion criteria (1 listed)
- Single ventricle patients who have received the Norwood Stage I operation.
Key exclusion criteria (4 listed)
- Infants with chromosomal anomalies or other non-cardiac conditions (cleft palate, necrotizing enterocolitis [NEC] or other gastrointestinal [GI] anomalies)
- Prematurity less than 37 weeks
- Infants greater than 30 days of age at Stage I palliation
- Parents who cannot read or understand questionnaires administered as a part of the study.
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
weight gain
Time frame: 5 months
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 13 Feb 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 Clabby, MD principal investigator
Children's Healthcare of Atlanta
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 Emory University 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 4 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 13 Feb 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?
weight gain (time frame: 5 months). 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 13 Feb 2014.