Clinical trial

Pathophysiological Evidence Driven Management of GERD in Neonatal ICU Infants: Randomized Controlled Trial

Name

STUDY00003300

Description

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.

Trial arms

Trial start

2024-03-14

Estimated PCD

2027-11-01

Trial end

2028-11-01

Status

Recruiting

Treatment

Omeprazole

Omeprazole will be the PPI prescribed for 4 weeks.

Arms:

Proton Pump Inhibitor (PPI)

Other names:

PPI

AR formula

Added rice formula will be ordered for 4 weeks.

Arms:

Added Rice (AR) Formula

Size

369

Primary endpoint

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

Decrease in ARI on treatment

At time 2 study (4 weeks or prior to discharge, whichever is earliest)

Decreased frequency of GER events on treatment

At time 2 study (4 weeks or prior to discharge, whichever is earliest)

Improvement (Increase) in distal baseline impedance on treatment

At time 2 study (4 weeks or prior to discharge, whichever is earliest)

Decrease in symptom associated probability on treatment

At time 2 study (4 weeks or prior to discharge, whichever is earliest)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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%).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 369, 'type': 'ESTIMATED'}}

Updated at

2024-06-07

1 organization

1 product

1 indication

Organization

Nationwide Children's Hospital

Product

Omeprazole

Indication

Gastroesophageal reflux disease