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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathleen Kennedy, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00131248
First received: August 15, 2005
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: November 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Interventions: Drug: Metaclopramide
Drug: Ranitidine
Drug: placebo

  Participant Flow
  Hide Participant Flow

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
n/a

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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


  More Information
  Hide More Information

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


Limitations and Caveats
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.  


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
Study First Received: August 15, 2005
Results First Received: November 23, 2009
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board