Trial Outcomes & Findings for Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial (NCT NCT02486263)
NCT ID: NCT02486263
Last Updated: 2020-07-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Up to 5 weeks after enrollment
Results posted on
2020-07-29
Participant Flow
Participant milestones
| Measure |
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)
* 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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
36
|
|
Overall Study
COMPLETED
|
37
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Baseline characteristics by cohort
| Measure |
Study
n=40 Participants
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)
* 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
n=36 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.7 weeks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
11.1 weeks
STANDARD_DEVIATION 4.5 • n=7 Participants
|
10.9 weeks
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
36 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeks after enrollmentThe 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.
Outcome measures
| Measure |
Study
n=40 Participants
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)
* 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
n=36 Participants
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.
|
|---|---|---|
|
CLINICAL OUTCOME OF FEEDING SUCCESS
|
33 percentage of participants
Interval 19.0 to 49.0
|
44 percentage of participants
Interval 28.0 to 62.0
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Study
n=18 Participants
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)
* 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
n=22 Participants
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.
|
|---|---|---|
|
MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes
|
0.5 odds ratio, week-5 vs. week-0
Interval 0.3 to 0.9
|
0.7 odds ratio, week-5 vs. week-0
Interval 0.4 to 1.0
|
SECONDARY outcome
Timeframe: at 5 weeksPopulation: Weight not available for three patients in conventional and one patient in study group at time 2
Growth: The investigators will measure and track weight growth velocity during the study period
Outcome measures
| Measure |
Study
n=37 Participants
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)
* 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
n=35 Participants
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.
|
|---|---|---|
|
CLINICAL OUTCOMES: Growth Outcome Measure
|
27.6 grams/day
Standard Deviation 11.1
|
26.5 grams/day
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Up to 1 year agePopulation: Those subjects with follow up data available at 1 year of age
Feeding Milestones: The investigators will track feeding method at 1 year.
Outcome measures
| Measure |
Study
n=22 Participants
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)
* 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
n=22 Participants
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.
|
|---|---|---|
|
CLINICAL OUTCOME: Development Outcome Measures
PO
|
17 Participants
|
20 Participants
|
|
CLINICAL OUTCOME: Development Outcome Measures
Transition (PO + tube)
|
4 Participants
|
0 Participants
|
|
CLINICAL OUTCOME: Development Outcome Measures
Tube
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at dischargeSupplemental oxygen requirement at discharge was recorded for both groups
Outcome measures
| Measure |
Study
n=37 Participants
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)
* 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
n=35 Participants
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.
|
|---|---|---|
|
CLINICAL OUTCOME: Respiratory Outcome Measures
|
7 Participants
|
9 Participants
|
Adverse Events
Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place