Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Information source: The University of Texas Health Science Center, Houston
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Metaclopramide and Ranitidine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s):
Kathleen A Kennedy, MD, MPH, Principal Investigator, Affiliation: University of Texas
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.
Clinical Details
Official title: Cross-Over Trial of Medical Treatment for GERD in Preterm Infants
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: apnea/bradycardia spells/day (comparison between the drug and placebo periods)
Detailed description:
Study Question: In premature infants with apnea and/or bradycardia attributed to GERD, does
treatment with H2 blockers and prokinetic agents, compared to placebo, reduce the frequency
of apnea and bradycardia?
Background: The incidence of gastroesophageal reflux (GER) has been reported in as many as
50% of healthy term infants and 63% of preterm infants. Anecdotal observations of apnea and
bradycardia clustered around feedings or with an episode of vomiting have suggested to
clinicians that apnea and bradycardia in preterm infants may be caused by reflux, however,
studies have failed to demonstrate even a temporal association between episodes of GER and
apnea. One retrospective study concluded that anti-reflux medications did not reduce the
frequency of apnea in premature infants. There have been no prospective randomized trials of
treatment for GERD in preterm infants with apnea or other symptoms attributed to GER. Despite
the lack of evidence supporting a causal relationship between GER and respiratory problems in
preterm infants and the lack of data regarding the efficacy or safety of the treatments for
GERD, many clinicians continue to believe that GER causes respiratory symptoms in preterm
infants and these infants are commonly treated with medications for GERD.
Specific aims: To determine whether medications for GER are effective in reducing
respiratory symptoms attributed to GER.
Methods: A randomized, controlled masked cross-over study will be performed. The cross-over
design will prevent evaluation of long-term outcomes but will increase the power to evaluate
short-term outcomes by using the patient as his/her own control. This cross-over design will
also 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. This approach for making therapeutic decisions in
individual patients has been described as an "N of 1" trial.
Eligibility
Minimum age: 1 Month.
Maximum age: 6 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of congenital neurological defect
- Imminent discharge (within 2 weeks)
- Parent refusal
Locations and Contacts
Memorial Hermann Children's Hospital, Houston, Texas 77030, United States
Additional Information
Starting date: April 2004
Ending date: March 2008
Last updated: June 4, 2008
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