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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK068158 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Ohio State University | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Arm - acid suppression plus feeding bundle | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CLINICAL OUTCOMES: Growth Outcome Measure | Growth: The investigators will measure and track weight growth velocity during the study period | at 5 weeks |
| CLINICAL OUTCOME: Development Outcome Measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudarshan R Jadcherla, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32380509 | Background | 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. | |
| 36310566 | Derived | Sultana 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study | Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)
|
| FG001 | Conventional | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis population is the same as the participant assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study | Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 weeks after enrollment |
|
up to 5 weeks during the study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions Study: -Omeprazole 0.75-1.5 milligrams/kilogram/dose twice a day (BID)
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sudarshan Jadcherla | Nationwide Children's Hospital | 614-355-6643 | sudarshan.jadcherla@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2019 | May 26, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2019 | May 26, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Conventional arm - acid suppression only | Other | -Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID) |
|
Feeding Milestones: The investigators will track feeding method at 1 year.
| Up to 1 year age |
| CLINICAL OUTCOME: Respiratory Outcome Measures | Supplemental oxygen requirement at discharge was recorded for both groups | at discharge |
| 33259163 | Derived | Jadcherla 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. |
| BG001 | Conventional | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Chronological age at time of inception | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Conventional | 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. |
|
|
|
| Primary | 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. | Participants must have motility evaluations completed at week 0 and week 5 and have PPI washout period prior to week 5 evaluation (49 infants had follow up motility studies at week 5 of whom 40 infants had PPI washout while the other 9 remained on PPI due to parental refusal to stop). | Posted | Number | 95% Confidence Interval | odds ratio, week-5 vs. week-0 | 5 weeks |
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|
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| Secondary | CLINICAL OUTCOMES: Growth Outcome Measure | Growth: The investigators will measure and track weight growth velocity during the study period | Weight not available for three patients in conventional and one patient in study group at time 2 | Posted | Mean | Standard Deviation | grams/day | at 5 weeks |
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|
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| Secondary | CLINICAL OUTCOME: Development Outcome Measures | Feeding Milestones: The investigators will track feeding method at 1 year. | Those subjects with follow up data available at 1 year of age | Posted | Count of Participants | Participants | Up to 1 year age |
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| Secondary | CLINICAL OUTCOME: Respiratory Outcome Measures | Supplemental oxygen requirement at discharge was recorded for both groups | Posted | Count of Participants | Participants | at discharge |
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|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Conventional | 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. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| Tube |
|