Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2020-03-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study

Treated with omeprazole. This group of subjects will have prescribed restricted feeding volumes, monitored feeding duration time and positioning restrictions

Group Type EXPERIMENTAL

Study Arm - acid suppression plus feeding bundle

Intervention Type 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

Treated with omeprazole. This group of subjects will receive the current standard treatment for Gastro-esophageal reflux disease (GERD) which includes use of acid suppressive medication with no restrictions of the feeding volume, duration or positioning.

Group Type OTHER

Conventional arm - acid suppression only

Intervention Type OTHER

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

Interventions

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Study Arm - acid suppression plus feeding bundle

* 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

Intervention Type OTHER

Conventional arm - acid suppression only

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

34 Weeks

Maximum Eligible Age

60 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No