Gastroesophageal Reflux DiseasePhase 4GERD-BPDNCT00926276
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
A Phase 4 study testing Fundoplication in people with Gastroesophageal Reflux Disease and Bronchopulmonary Dysplasia, 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 evaluate the efficacy of fundoplication in premature infants with GERD and BPD. Read more about this study
- Who is it for?
- Ages 24 weeks to 1 year
- Conditions the study is for
- Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia
- What is being tested?
- Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2013
- Phase
- Phase 4
- 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 24 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Must meet all inclusion criteria for Initial Evaluation of GERD
- Positive pH-MII test for GERD
- Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies
- > or = 2 kg (due to technical limitations of fundoplication)
Who cannot join
- Previous intra-abdominal surgery except for gastrostomy
- Those deemed not surgical candidates
- Infants with associated congenital gastrointestinal anomalies
- > or = 1 year of age at time of Initial Evaluation of GERD
Trial locations and contacts
1 site in 1 country.
United States1 site
UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital
Houston, Texas, 77030
About this study
Official title: The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Read the detailed description
Gastroesophageal reflux disease (GERD) has been postulated to result in chronic aspiration contributing to the development of chronic lung disease, otherwise known as bronchopulmonary dysplasia (BPD) in premature infants. This association has been indirectly based on anecdotal improvement in the respiratory status of infants with BPD after anti-reflux therapy, but the direct causal relationship has been difficult to prove. In addition, the historical evidence for infants with GERD has been based on acid reflux only which is diagnosed by 24 hour intra-esophageal pH monitoring, the gold standard. However, with the introduction of multi-channel intraluminal impedance (MII), GERD can now include non-acid reflux. The contribution of non-acid reflux to the development of BPD in premature infants is unknown. As our understanding of GERD has improved, previous assumptions regarding the efficacy of therapy may no longer be valid. The utilization of anti-reflux surgery (fundoplication) for the treatment of BPD in premature infants with GERD has not been rigorously studied. The efficacy of fundoplication in this patient population has yet to be determined.
- Being tested
- Fundoplication
- Keywords
- Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication
- Medical subject headings
- Gastroesophageal Reflux, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FundoplicationProcedure or surgery
Fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment Group-Fundoplication | Active comparator | Re-evaluated 1 month post-op Re-evaluated 2 months post-op Receives: Procedure: Fundoplication |
| Medical Therapy | Active comparator | Treated by primary clinician for GERD Re-evaluated 1 month Proceed to Fundoplication if GERD persist by pH-MII Re-evaluated at 2 months (1 month post-op) Worsening BPD will be given option of immediate surgery Receives: Procedure: Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Measured: Three months
Secondary outcomes (1)
Establish preliminary data regarding the correlation between acid and non-acid GERD and pepsin from tracheal aspirates as a marker of chronic aspiration in premature infants with BPD.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KuoJen Tsao, The University of Texas Health Science Center, Houston
- Investigators
- KuoJen Tsao, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926276
- Sponsor's protocol ID
- GERD-BPD
- Acronym
- GERD-BPD
- Status last verified
- Dec 2014
- First submitted
- 19 Jun 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
- ClinicalTrials.gov ID
- NCT00926276
- Acronym / sponsor ID
- GERD-BPD / GERD-BPD
- Keywords
- Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jun 2009 (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 evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Detailed description
Gastroesophageal reflux disease (GERD) has been postulated to result in chronic aspiration contributing to the development of chronic lung disease, otherwise known as bronchopulmonary dysplasia (BPD) in premature infants. This association has been indirectly based on anecdotal improvement in the respiratory status of infants with BPD after anti-reflux therapy, but the direct causal relationship has been difficult to prove. In addition, the historical evidence for infants with GERD has been based on acid reflux only which is diagnosed by 24 hour intra-esophageal pH monitoring, the gold standard. However, with the introduction of multi-channel intraluminal impedance (MII), GERD can now include non-acid reflux. The contribution of non-acid reflux to the development of BPD in premature infants is unknown. As our understanding of GERD has improved, previous assumptions regarding the efficacy of therapy may no longer be valid. The utilization of anti-reflux surgery (fundoplication) for the treatment of BPD in premature infants with GERD has not been rigorously studied. The efficacy of fundoplication in this patient population has yet to be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment Group-Fundoplication | Active comparator | Procedure: FundoplicationRe-evaluated 1 month post-op Re-evaluated 2 months post-op |
| Medical Therapy | Active comparator | Procedure: FundoplicationTreated by primary clinician for GERD Re-evaluated 1 month Proceed to Fundoplication if GERD persist by pH-MII Re-evaluated at 2 months (1 month post-op) Worsening BPD will be given option of immediate surgery |
Who may qualify
- Ages
- 24 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Must meet all inclusion criteria for Initial Evaluation of GERD
- Positive pH-MII test for GERD
- Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies
- > or = 2 kg (due to technical limitations of fundoplication)
Key exclusion criteria (4 listed)
- Previous intra-abdominal surgery except for gastrostomy
- Those deemed not surgical candidates
- Infants with associated congenital gastrointestinal anomalies
- > or = 1 year of age at time of Initial Evaluation of GERD
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 |
|---|---|---|
| FundoplicationFundoplication | Procedure or surgery | Medical Therapy, Surgical Treatment Group-Fundoplication |
Primary outcome
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Time frame: Three months
1 secondary outcome
Establish preliminary data regarding the correlation between acid and non-acid GERD and pepsin from tracheal aspirates as a marker of chronic aspiration in premature infants with BPD.
Time frame: Six 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 11 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.
KuoJen Tsao, M.D. 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?
A Phase 4 study testing Fundoplication in people with Gastroesophageal Reflux Disease and Bronchopulmonary Dysplasia, 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 4 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 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. (time frame: Three 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 11 Dec 2014.