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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00131248
Recruitment Status : Completed
First Posted : August 17, 2005
Results First Posted : January 15, 2014
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Kathleen Kennedy, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux
Interventions Drug: Metaclopramide
Drug: Ranitidine
Drug: placebo
Enrollment 18
Recruitment Details participants = premature infants, <36 weeks gestation at birth, recruited from NICU at a hospital in Houston, Texas,USA, between 2004-2009
Pre-assignment Details  
Arm/Group Title Medications, Placebo, Medications (Group 1) Placebo, Medications, Placebo (Group 2)
Hide Arm/Group Description

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 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.

received 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.
Period Title: Intervention 1 (3-day Course)
Started 9 9
Completed 8 9
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Washout (24 Hour)
Started 8 9
Completed 8 9
Not Completed 0 0
Period Title: Intervention 2 (7-day Course)
Started 8 9
Completed 8 9
Not Completed 0 0
Period Title: Washout 2 (24 Hours)
Started 8 9
Completed 8 9
Not Completed 0 0
Period Title: Intervention 3 (4-day Course)
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
18 participants initially enrolled; 1 withdrew, leaving 17 participants analyzed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
17
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
0.1  (0.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
12
  70.6%
Male
5
  29.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Bradycardia Episodes/Day
Hide Description [Not Specified]
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed.
Arm/Group Title Medications Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: episodes per day
4.6  (3.1) 3.6  (2.7)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population include only those who received study intervention.
 
Arm/Group Title Medications Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Medications Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen A. Kennedy, MD, MPH
Organization: UT Houston Medical School
Phone: 713 500-6708
EMail: kathleen.a.kennedy@uth.tmc.edu
Publications of Results:
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.
Layout table for additonal information
Responsible Party: Kathleen Kennedy, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00131248    
Other Study ID Numbers: GERD
First Submitted: August 15, 2005
First Posted: August 17, 2005
Results First Submitted: November 23, 2009
Results First Posted: January 15, 2014
Last Update Posted: January 15, 2014