Gastroesophageal Reflux DiseaseGMTNCT02486263
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
A study testing Study Arm - acid suppression plus feeding bundle and Conventional arm - acid suppression only in people with Gastroesophageal Reflux Disease, run by Sudarshan Jadcherla at 1 site in United States.
Trial summary
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Read more about this study
- Who is it for?
- Ages 34 to 60 weeks
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Study Arm - acid suppression plus feeding bundle and Conventional arm - acid suppression only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 to 60 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized infants with aerodigestive or GERD symptoms
- Gestational age ≤42 weeks
- Premature infants are eligible at 34 weeks postmenstrual age (PMA)
- Enteral or Oral Fed
- Average daily total feeding volume ≥ 150ml/kg/day
- Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula
Who cannot join
- Known genetic, metabolic or syndromic disease
- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
- Gastrointestinal malformations and surgical gastrointestinal conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.
In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.
Read the detailed description
Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.
The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Study Arm - acid suppression plus feeding bundle, Conventional arm - acid suppression only
- Keywords
- infant, esophagitis, neonate, GERD
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Arm - acid suppression plus feeding bundleOther
- Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
- Total fluid volume restriction (120-140 milliliters/kilogram/day)
- Feeding duration over 30 minutes
- Infant feeds with right side down
- Infant is placed on back following feeds
Conventional arm - acid suppression onlyOther
-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions Receives: Other: Study Arm - acid suppression plus feeding bundle |
| Conventional | Other | Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning. Receives: Other: Conventional arm - acid suppression only |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLINICAL OUTCOME OF FEEDING SUCCESS
The primary endpoint is the feeding success defined as achieving full oral feeds (defined as no need for tube feeds to maintain hydration and nutrition) and/or a >/= 6 point decrease from baseline symptom score as described by the Infant-Gastro-Esophageal Reflux Questionnaire-Revised. The minimum score is 0 (no symptoms) and the maximum score is 42 (maximum symptoms). Any total score greater than or equal to 16 is considered abnormal.
Measured: Up to 5 weeks after enrollment
MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes
This is part of Aim 2 of this RCT, which is a mechanistic outcome designed to understand the reasons for the clinical outcome. Presence of peristaltic reflex mechanisms elicited upon esophageal provocation during esophageal manometry were compared within the groups, week-5 vs. week-0. Odds ratios (ORs) with 95% confidence interval (CI) are reported from Generalized Estimation Equation models.
Measured: 5 weeks
Secondary outcomes (3)
CLINICAL OUTCOMES: Growth Outcome Measure
Growth: The investigators will measure and track weight growth velocity during the study period
Measured: at 5 weeks
CLINICAL OUTCOME: Development Outcome Measures
Feeding Milestones: The investigators will track feeding method at 1 year.
Measured: Up to 1 year age
CLINICAL OUTCOME: Respiratory Outcome Measures
Supplemental oxygen requirement at discharge was recorded for both groups
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startDec 2012
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudarshan Jadcherla
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University
- Responsible party
- Sponsor-investigator, Sudarshan Jadcherla, Nationwide Children's Hospital
- Investigators
- Sudarshan R Jadcherla, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486263
- Sponsor's protocol ID
- 11-00734
- Other IDs
- R01DK068158
- Acronym
- GMT
- Status last verified
- Jul 2020
- First submitted
- 17 Jun 2015
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jadcherla SR, Hasenstab KA, Wei L, Osborn EK, Viswanathan S, Gulati IK, Slaughter JL, Di Lorenzo C. Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial. Pediatr Res. 2021 Feb;89(3):645-652. doi: 10.1038/s41390-020-0932-4. Epub 2020 May 7.
PubMed 32380509Sultana Z, Hasenstab KA, Moore RK, Osborn EK, Yildiz VO, Wei L, Slaughter JL, Jadcherla SR. Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux. Gastro Hep Adv. 2022;1(5):869-881. doi: 10.1016/j.gastha.2022.06.004. Epub 2022 Jun 20.
PubMed 36310566Jadcherla SR, Hasenstab KA, Gulati IK, Helmick R, Ipek H, Yildiz V, Wei L. Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Nov;11(11):e00249. doi: 10.14309/ctg.0000000000000249.
PubMed 33259163
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial
- ClinicalTrials.gov ID
- NCT02486263
- Acronym / sponsor ID
- GMT / 11-00734
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- infant, esophagitis, neonate, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Sudarshan JadcherlaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University
- Study start
- Dec 2012
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.
In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.
Detailed description
Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.
The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: Study Arm - acid suppression plus feeding bundleTreated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions |
| Conventional | Other | Other: Conventional arm - acid suppression onlyTreated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning. |
Who may qualify
- Ages
- 34 to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Hospitalized infants with aerodigestive or GERD symptoms
- Gestational age ≤42 weeks
- Premature infants are eligible at 34 weeks postmenstrual age (PMA)
- Enteral or Oral Fed
- Average daily total feeding volume ≥ 150ml/kg/day
Key exclusion criteria (3 listed)
- Known genetic, metabolic or syndromic disease
- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
- Gastrointestinal malformations and surgical gastrointestinal conditions
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 |
|---|---|---|
| Study Arm - acid suppression plus feeding bundle* Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) * Total fluid volume restriction (120-140 milliliters/kilogram/day) * Feeding duration over 30 minutes * Infant feeds with right side down * Infant is placed on back following feeds | Other | Study |
| Conventional arm - acid suppression only-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) | Other | Conventional |
Primary outcome
CLINICAL OUTCOME OF FEEDING SUCCESS
Time frame: Up to 5 weeks after enrollment
The primary endpoint is the feeding success defined as achieving full oral feeds (defined as no need for tube feeds to maintain hydration and nutrition) and/or a >/= 6 point decrease from baseline symptom score as described by the Infant-Gastro-Esophageal Reflux Questionnaire-Revised. The minimum score is 0 (no symptoms) and the maximum score is 42 (maximum symptoms). Any total score greater than or equal to 16 is considered abnormal.
MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes
Time frame: 5 weeks
This is part of Aim 2 of this RCT, which is a mechanistic outcome designed to understand the reasons for the clinical outcome. Presence of peristaltic reflex mechanisms elicited upon esophageal provocation during esophageal manometry were compared within the groups, week-5 vs. week-0. Odds ratios (ORs) with 95% confidence interval (CI) are reported from Generalized Estimation Equation models.
3 secondary outcomes
CLINICAL OUTCOMES: Growth Outcome Measure
Time frame: at 5 weeks
CLINICAL OUTCOME: Development Outcome Measures
Time frame: Up to 1 year age
CLINICAL OUTCOME: Respiratory Outcome Measures
Time frame: at discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32380509Jadcherla SR, Hasenstab KA, Wei L, Osborn EK, Viswanathan S, Gulati IK, Slaughter JL, Di Lorenzo C. Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial. Pediatr Res. 2021 Feb;89(3):645-652. doi: 10.1038/s41390-020-0932-4. Epub 2020 May 7.
- Derived from this study: PubMed 36310566Sultana Z, Hasenstab KA, Moore RK, Osborn EK, Yildiz VO, Wei L, Slaughter JL, Jadcherla SR. Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux. Gastro Hep Adv. 2022;1(5):869-881. doi: 10.1016/j.gastha.2022.06.004. Epub 2022 Jun 20.
- Derived from this study: PubMed 33259163Jadcherla SR, Hasenstab KA, Gulati IK, Helmick R, Ipek H, Yildiz V, Wei L. Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Nov;11(11):e00249. doi: 10.14309/ctg.0000000000000249.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
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.
Sudarshan R Jadcherla, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Arm - acid suppression plus feeding bundle and Conventional arm - acid suppression only in people with Gastroesophageal Reflux Disease, run by Sudarshan Jadcherla 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 6 inclusion and 3 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 29 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CLINICAL OUTCOME OF FEEDING SUCCESS (time frame: Up to 5 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486263, which also lists 3 linked publications.
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 29 Jul 2020.