Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants

NCT00131248 | Completed Phase 3 Results

• 1 other identifier: GERD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Study Question: In premature infants with apnea and/or bradycardia attributed to gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and motility agents), compared to placebo, reduce the frequency of apnea and bradycardia? Background: Many clinicians believe that apnea and bradycardia in preterm infants may be caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a temporal association between episodes of GER and apnea. There have been no prospective randomized trials of treatment for GERD in preterm infants with apnea or other symptoms attributed to GER. Methods: A randomized, cross-over study will be performed. This cross-over design will provide the patient's clinician with unbiased information about the patient's response to treatment. The clinician can use this information in deciding whether or not to continue treatment after the two-week study period.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Bradycardia Episodes/Day

  7 days

Study Arms (2)

Anti-reflux Medications, then Placebo (group 1)

OTHER

3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications. All study medication administered via nipple or orogastric (OG) tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.

Drug: Metaclopramide; Drug: Ranitidine; Drug: placebo

Placebo, then Anti-reflux Medications

OTHER

3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo. All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes.

Drug: Metaclopramide; Drug: Ranitidine; Drug: placebo

Interventions

Metaclopramide DRUG

Anti-reflux Medications, then Placebo (group 1); Placebo, then Anti-reflux Medications

Ranitidine DRUG

Anti-reflux Medications, then Placebo (group 1); Placebo, then Anti-reflux Medications

placebo DRUG

Anti-reflux Medications, then Placebo (group 1); Placebo, then Anti-reflux Medications

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants \< 37 weeks gestation at birth; currently less than 44 weeks postmenstrual age.
• Not currently receiving mechanical ventilation
• Clinical diagnosis of GER and apnea/bradycardia suspected by the clinicians to be related to the GER. (Supporting diagnostic test information, such as upper gastrointestinal series \[UGI\] studies and pH probes will be recorded but not required for study enrollment.)
• Attending physician plan to begin anti-reflux medications
• Infants may be included in the study if they are on continuous positive airway pressure (CPAP) or methylxanthines for treatment of apnea only if the clinicians are willing to maintain the same regimen for the two-week duration of the study.
• Stable feeding regimen

You may not qualify if:

• History of congenital neurological defect
• Imminent discharge (within 2 weeks)
• Parent refusal

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Wheatley E, Kennedy KA. Cross-over trial of treatment for bradycardia attributed to gastroesophageal reflux in preterm infants. J Pediatr. 2009 Oct;155(4):516-21. doi: 10.1016/j.jpeds.2009.03.044. Epub 2009 Jun 21.

  PMID: 19540518 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Metoclopramide; Ranitidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kathleen A. Kennedy, MD, MPH
• Organization: UT Houston Medical School

kathleen.a.kennedy@uth.tmc.edu

713 500-6708

Study Officials

• Kathleen A Kennedy, MD, MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Pediatrics-Neonatology

Study Record Dates

• First Submitted: August 15, 2005
• First Posted: August 17, 2005
• Study Start: April 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 15, 2014
• Results First Posted: January 15, 2014

Record last verified: 2013-12

Locations

US (1)