Single Ventricle PhysiologyNCT02995577
Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
An observational study of Single Ventricle Physiology, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery. Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Single Ventricle Physiology
- What is being tested?
- Feeding tolerant, Feeding intolerant and Necrotizing enterocolitis
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to May 2018
- 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 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will be infants with complex congenital cyanotic heart disease requiring single ventricle staged palliation surgery at Children's Memorial Hermann Hospital (CMHH) at the Texas Medical Center. This will include neonates undergoing single ventricle staged palliation in the form of (a) Norwood-type procedure, (b) systemic-to-pulmonary artery shunt procedure, or (c) pulmonary artery banding.
Who may be able to join
- Full term gestational period (37 weeks gestation or greater)
- minimum of 2.5kg or greater body weight
- diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease requiring staged palliation surgery in the form of Norwood-type procedure, systemic-to-pulmonary artery shunt, or pulmonary artery banding.
Who cannot join
- Have diseases affecting other organs,
- have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE syndrome, or VACTERL association.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Supriya Nair, MD, 832-582-0683, Supriya.Nair@uth.tmc.edu
About this study
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.
- Conditions
- Single Ventricle Physiology
- Being tested
- Feeding tolerant, Feeding intolerant, Necrotizing enterocolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding tolerantOther
Feeding intolerantOther
Necrotizing enterocolitisOther
| Study group | Role | What they receive |
|---|---|---|
| Feeding tolerant | Patients that are able to reach 80-100% of full enteral feeds (whether fed by mouth or through a nasogastric tube) 7 days after the initiation of feeds. Patients will be excluded from this group if they are ever diagnosed with NEC at any time during this hospitalization. Receives: Other: Feeding tolerant | |
| Feeding intolerant | Patients with GI symptoms (vomiting, abdominal distention, diarrhea, hematemesis, and/or hematochezia) that persist for 48 hours or longer while needing to be NPO, this patient is retrospectively categorized into the feeding intolerance group. Patients with feeding intolerance may also include infants that are made NPO, placed on bowel rest, and are started on antibiotics to rule out NEC, but are never diagnosed with NEC. Exclusion criteria include patients that are continued on antibiotics for greater than 48 hours due to diagnosed bacterial sepsis or diagnosed NEC, and those that have a positive blood, urine, or sputum culture. Receives: Other: Feeding intolerant | |
| Necrotizing enterocolitis | Any infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC. Receives: Other: Necrotizing enterocolitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of most abundant serum protein as determined by ELISA
We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.
Measured: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of second most abundant serum protein as determined by ELISA
Measured: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA
Measured: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of stool biomarker calprotectin as determined by ELISA
Measured: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Ventricle PhysiologyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supriya Nair, The University of Texas Health Science Center, Houston
- Investigators
- Supriya Nair, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995577
- Sponsor's protocol ID
- HSC-MS-16-0968
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
- ClinicalTrials.gov ID
- NCT02995577
- Acronym / sponsor ID
- HSC-MS-16-0968
- Conditions
- Single Ventricle Physiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- May 2018 (estimated)
- First posted
- 16 Dec 2016 (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 of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feeding tolerant | – | Other: Feeding tolerantPatients that are able to reach 80-100% of full enteral feeds (whether fed by mouth or through a nasogastric tube) 7 days after the initiation of feeds. Patients will be excluded from this group if they are ever diagnosed with NEC at any time during this hospitalization. |
| Feeding intolerant | – | Other: Feeding intolerantPatients with GI symptoms (vomiting, abdominal distention, diarrhea, hematemesis, and/or hematochezia) that persist for 48 hours or longer while needing to be NPO, this patient is retrospectively categorized into the feeding intolerance group. Patients with feeding intolerance may also include infants that are made NPO, placed on bowel rest, and are started on antibiotics to rule out NEC, but are never diagnosed with NEC. Exclusion criteria include patients that are continued on antibiotics for greater than 48 hours due to diagnosed bacterial sepsis or diagnosed NEC, and those that have a positive blood, urine, or sputum culture. |
| Necrotizing enterocolitis | – | Other: Necrotizing enterocolitisAny infant that is diagnosed (radiographically, by Bell's criteria) with and treated for NEC. |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will be infants with complex congenital cyanotic heart disease requiring single ventricle staged palliation surgery at Children's Memorial Hermann Hospital (CMHH) at the Texas Medical Center. This will include neonates undergoing single ventricle staged palliation in the form of (a) Norwood-type procedure, (b) systemic-to-pulmonary artery shunt procedure, or (c) pulmonary artery banding.
Key inclusion criteria (3 listed)
- Full term gestational period (37 weeks gestation or greater)
- minimum of 2.5kg or greater body weight
- diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease requiring staged palliation surgery in the form of Norwood-type procedure, systemic-to-pulmonary artery shunt, or pulmonary artery banding.
Key exclusion criteria (2 listed)
- Have diseases affecting other organs,
- have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE syndrome, or VACTERL association.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding tolerant | Other | Feeding tolerant |
| Feeding intolerant | Other | Feeding intolerant |
| Necrotizing enterocolitis | Other | Necrotizing enterocolitis |
Primary outcome
Level of most abundant serum protein as determined by ELISA
Time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.
Level of second most abundant serum protein as determined by ELISA
Time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA
Time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of stool biomarker calprotectin as determined by ELISA
Time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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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.
Supriya Nair, MD principal investigator
The University of Texas Health Science Center, Houston
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 Single Ventricle Physiology, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Supriya Nair, MD (832-582-0683, Supriya.Nair@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of most abundant serum protein as determined by ELISA (time frame: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery). The study lists 4 primary outcomes in all. 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 16 Dec 2016.