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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131248
First Posted: August 17, 2005
Last Update Posted: January 15, 2014
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.
Information provided by (Responsible Party):
Kathleen Kennedy, The University of Texas Health Science Center, Houston
Results First Submitted: November 23, 2009  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
participants = premature infants, <36 weeks gestation at birth, recruited from NICU at a hospital in Houston, Texas,USA, between 2004-2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Medications, Placebo, Medications (Group 1)

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.

Placebo, Medications, Placebo (Group 2)

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.


Participant Flow for 5 periods

Period 1:   Intervention 1 (3-day Course)
    Medications, Placebo, Medications (Group 1)   Placebo, Medications, Placebo (Group 2)
STARTED   9   9 
COMPLETED   8   9 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 

Period 2:   Washout (24 Hour)
    Medications, Placebo, Medications (Group 1)   Placebo, Medications, Placebo (Group 2)
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 

Period 3:   Intervention 2 (7-day Course)
    Medications, Placebo, Medications (Group 1)   Placebo, Medications, Placebo (Group 2)
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 

Period 4:   Washout 2 (24 Hours)
    Medications, Placebo, Medications (Group 1)   Placebo, Medications, Placebo (Group 2)
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 

Period 5:   Intervention 3 (4-day Course)
    Medications, Placebo, Medications (Group 1)   Placebo, Medications, Placebo (Group 2)
STARTED   8   9 
COMPLETED   8   9 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
18 participants initially enrolled; 1 withdrew, leaving 17 participants analyzed.

Reporting Groups
  Description
All Study Participants No text entered.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
 
<=18 years   17 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 0.1  (0.06) 
Gender 
[Units: Participants]
 
Female   12 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures

1.  Primary:   Bradycardia Episodes/Day   [ Time Frame: 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kathleen A. Kennedy, MD, MPH
Organization: UT Houston Medical School
phone: 713 500-6708
e-mail: kathleen.a.kennedy@uth.tmc.edu


Publications of Results:

Responsible Party: Kathleen Kennedy, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00131248     History of Changes
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