Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

Gastroesophageal Reflux Disease Clinical Trial

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Official title:

Pathophysiology of the Aerodigestive Reflex in Infants: GERD Management Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486263
• Other study ID #: 11-00734
• Secondary ID: R01DK068158
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Weeks to 60 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• 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
• Conventional arm - acid suppression only
-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)

Locations

Country	Name	City	State
United States	The Research Institute at Nationwide Children's Hospital	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Sudarshan Jadcherla	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jadcherla SR, Hasenstab KA, Wei L, Osborn EK, Viswanathan S, Gulati IK, Slaughter JL, Di Lorenzo C. Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial. Pediatr Res. 2020 May 7. doi: 10.1038/s41390-020-0932-4. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CLINICAL OUTCOME OF FEEDING SUCCESS	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.	Up to 5 weeks after enrollment
Primary	MOTILITY OUTCOMES: Presence of Esophageal Peristaltic Reflexes	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.	5 weeks
Secondary	CLINICAL OUTCOMES: Growth Outcome Measure	Growth: The investigators will measure and track weight growth velocity during the study period	at 5 weeks
Secondary	CLINICAL OUTCOME: Development Outcome Measures	Feeding Milestones: The investigators will track feeding method at 1 year.	Up to 1 year age
Secondary	CLINICAL OUTCOME: Respiratory Outcome Measures	Supplemental oxygen requirement at discharge was recorded for both groups	at discharge