Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial

NCT02486263 | Completed Results DMC

• 2 other identifiers: 11-00734R01DK068158
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

infant; esophagitis; neonate; GERD

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• CLINICAL OUTCOMES: Growth Outcome Measure

  at 5 weeks

• CLINICAL OUTCOME: Development Outcome Measures

  Up to 1 year age

• CLINICAL OUTCOME: Respiratory Outcome Measures

  at discharge

Study Arms (2)

Study

EXPERIMENTAL

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

Other: Study Arm - acid suppression plus feeding bundle

Conventional

OTHER

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.

Other: Conventional arm - acid suppression only

Interventions

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

Study

Conventional arm - acid suppression only OTHER

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

Conventional

Eligibility Criteria

• Age: 34 Weeks - 60 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudarshan Jadcherla: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Ohio State University: collaborator

Study Sites (1)

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

• 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. 2021 Feb;89(3):645-652. doi: 10.1038/s41390-020-0932-4. Epub 2020 May 7.

  PMID: 32380509 BACKGROUND

• Sultana Z, Hasenstab KA, Moore RK, Osborn EK, Yildiz VO, Wei L, Slaughter JL, Jadcherla SR. Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux. Gastro Hep Adv. 2022;1(5):869-881. doi: 10.1016/j.gastha.2022.06.004. Epub 2022 Jun 20.

  PMID: 36310566 DERIVED

• Jadcherla SR, Hasenstab KA, Gulati IK, Helmick R, Ipek H, Yildiz V, Wei L. Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Nov;11(11):e00249. doi: 10.14309/ctg.0000000000000249.

  PMID: 33259163 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Results Point of Contact

• Title: Dr. Sudarshan Jadcherla
• Organization: Nationwide Children's Hospital

sudarshan.jadcherla@nationwidechildrens.org

614-355-6643

Study Officials

• Sudarshan R Jadcherla, MD

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 1, 2015
• Study Start: December 1, 2012
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 29, 2020
• Results First Posted: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)