Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131248
Status:
COMPLETED
Last Update Posted:
2014-01-15
First Post:
2005-08-15
Brief Title:
Medical Treatment for Gastroesophageal Reflux Disease GERD in Preterm Infants
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Cross-over Trial of Medical Treatment for GERD in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Question In premature infants with apnea andor 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 patients clinician with unbiased information about the patients response to treatment The clinician can use this information in deciding whether or not to continue treatment after the two-week study period
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 patients clinician with unbiased information about the patients response to treatment The clinician can use this information in deciding whether or not to continue treatment after the two-week study period
Detailed Description:
Study Question In premature infants with apnea andor 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 hisher own control This cross-over design will also provide the patients clinician with unbiased information about the patients 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
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 hisher own control This cross-over design will also provide the patients clinician with unbiased information about the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None