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Completed

NCT Number: NCT02486263

Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known. Many infants have GERD and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. Some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most GERD treatments are done based on experience, but there is no scientific proof that these methods work for infants. GERD and feeding difficulties can lead to longer hospitalization and more stress for the family.

In this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving GERD and GERD complications.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases

Age range

34 week–60 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD therapies are unclear. Significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants. The long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes.

The current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized infants with aerodigestive or GERD symptoms
  • Gestational age ≤42 weeks
  • Premature infants are eligible at 34 weeks postmenstrual age (PMA)
  • Enteral or Oral Fed
  • Average daily total feeding volume ≥ 150ml/kg/day
  • Room air or supplemental oxygen of ≤1 liter/minute (LPM) and/or ≤ 35% by nasal cannula

Exclusion criteria

  • Known genetic, metabolic or syndromic disease
  • Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH) and perinatal asphyxia
  • Gastrointestinal malformations and surgical gastrointestinal conditions

Treatment and study plan

Study Arm - acid suppression plus feeding bundle

Other
  • Omeprazole 0.5-1.5 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 arm - acid suppression only

Other

-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)

Primary outcomes

  1. CLINICAL OUTCOME OF FEEDING SUCCESS

    Time frame: Up to 5 weeks after enrollment

    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.

  2. MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. CLINICAL OUTCOMES: Growth Outcome Measure

    Time frame: at 5 weeks

    Growth: The investigators will measure and track weight growth velocity during the study period

  2. CLINICAL OUTCOME: Development Outcome Measures

    Time frame: Up to 1 year age

    Feeding Milestones: The investigators will track feeding method at 1 year.

  3. CLINICAL OUTCOME: Respiratory Outcome Measures

    Time frame: at discharge

    Supplemental oxygen requirement at discharge was recorded for both groups

Sponsors and collaborators

Lead sponsor

Sudarshan Jadcherla

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Ohio State University

Registry information

Official study title

Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial

Acronym: GMT

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2015
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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