GERD in Infants
Conditions
Keywords
Proton Pump Inhibitor, pH Impedance, added rice formula
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.
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.
Interventions
DRUGOmeprazole
Omeprazole will be the PPI prescribed for 4 weeks.
OTHERAR formula
Added rice formula will be ordered for 4 weeks.
Sponsors
Nationwide Children's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Infants will be randomized to one of three arms: Natural maturation, Proton Pump Inhibitor (PPI) treatment, or Added rice (AR) formula. Subjects will be stratified and allocated 1:1:1 based on tube feeds (yes or no) and ARI (3-7% or \>7%).
Eligibility
Sex/Gender
ALL
Age
1 Days to 8 Months
Healthy volunteers
No
Inclusion criteria
* NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements: * GERD diagnosis using pH-impedance criteria (Acid Reflux Index ≥ 3% plus at least one of the following: # GER events \>70 / day, Symptom Associated Probability ≥ 95%, Discal Baseline Impedance \< 900 Ω) * Full enteral feeds * No current GERD therapies
Exclusion criteria
* Known lethal chromosomal abnormalities or complex congenital syndromes * Severe neurologic pathologies requiring neuroactive medications or neurosurgery * Positive airway pressure or oxygen flow \> 4 LPM * Upper gastrointestinal malformations requiring surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of primary outcome: Improvement or maintenance of oral feeding and/or absence of GERD symptoms (based on feeding method at inception) | At 4 weeks of therapy or discharge, whichever occurs first | Achievement of the primary outcome will be measured by treatment group to determine efficacy. For subjects on full oral feeds at inception, the primary outcome will be met if there is maintenance of oral feeds AND absence of associated GERD symptoms. For subjects receiving any tube feeding at inception, the primary outcome will be met if there is improvement in oral feeding (ratio of oral to tube feeds) OR absence of troublesome symptoms. The metric for measuring the absence of troublesome symptoms will be vomiting \<2 times/day or coughing \<18 times/day. |
| Decrease in ARI on treatment | At time 2 study (4 weeks or prior to discharge, whichever is earliest) | Change in acid reflux index from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups. |
| Decreased frequency of GER events on treatment | At time 2 study (4 weeks or prior to discharge, whichever is earliest) | Change in number of reflux events from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups. |
| Improvement (Increase) in distal baseline impedance on treatment | At time 2 study (4 weeks or prior to discharge, whichever is earliest) | Change in distal baseline impedance from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups. |
| Decrease in symptom associated probability on treatment | At time 2 study (4 weeks or prior to discharge, whichever is earliest) | Change in symptom associated probability from time one pH impedance study (prior to treatment) to time 2 pH impedance study (during treatment) will be compared among treatment groups. |
Countries
United States
Contacts
CONTACTErika K Osborn
CONTACTPatty Luzader
PRINCIPAL_INVESTIGATORSudarshan R sudarshan.jadcherla@nationwidechildrens.org
Nationwide Children's Hospital
Outcome results
None listed