RECRUITING

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-14
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06114836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 8 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * NICU infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements:
  2. * 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)
  3. * Full enteral feeds
  4. * No current GERD therapies
  1. * Known lethal chromosomal abnormalities or complex congenital syndromes
  2. * Severe neurologic pathologies requiring neuroactive medications or neurosurgery
  3. * Positive airway pressure or oxygen flow \> 4 LPM
  4. * Upper gastrointestinal malformations requiring surgery

Contacts and Locations

Study Contact

Erika K Osborn
CONTACT
6143556667
erika.osborn@nationwidechildrens.org
Patty Luzader
CONTACT
6143556627
patty.luzader@nationwidechildrens.org

Principal Investigator

Sudarshan R sudarshan.jadcherla@nationwidechildrens.org
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Nationwide Children's Hospita
Columbus, Ohio, 43215
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Sudarshan R sudarshan.jadcherla@nationwidechildrens.org, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-14
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-03-14
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • Proton Pump Inhibitor
  • pH Impedance
  • added rice formula

Additional Relevant MeSH Terms

  • GERD in Infants