Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06114836
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-10-26
Brief Title:
GERD Infant Feeding Therapeutics Trial GIFT Trial
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFT
Brief Summary:
The goal of this investigator-initiated single-center randomized controlled trial RCT is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm parallel design in NICU infants with objective GERD diagnosis The three therapies being compared are natural maturation proton pump inhibitor PPI use and added rice AR formula use The main goals are
to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms as defined below
to characterize the mechanisms of primary end point success or failure using pH-Impedance metrics
to evaluate and compare the efficacy of the three commonly used treatment interventions used in the NICU for GERD in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms as defined below
to characterize the mechanisms of primary end point success or failure using pH-Impedance metrics
Detailed Description:
In consented subjects eligibility is determined after initial diagnostic 24-hour pH Impedance test These subjects will be randomized to one of the 3 arms of the study natural maturation PPI AR formula for 4 weeks of treatment A second 24-hour pH Impedance test will be done on therapy at 4 weeks or before discharge whichever occurs first Primary outcome will also be measured at 4 weeks or at discharge whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK136762-01 | NIH | None | httpsreporternihgovquickSearch1R01DK136762-01 |