Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00888017
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2009-04-08
Brief Title:
Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPI
Brief Summary:
Previous research studies have shown that there may be a connection between proton pump inhibitor therapies and hip fracture in adults1 Proton pump inhibitorPPI reflux medications raise the pH of the stomach which may effect the bodys ability to absorb certain calcium compounds
Neonates are at a crucial age for bone mineralization Because esophageal reflux is common in neonates PPI therapy is commonly used despite little information on effectiveness and side effects PPIs work by blocking the production of protons in the pumps in the stomach thus making the stomach less acidic The calcium ion needs an acidic environment in order to be broken down from its natural compounds into an absorbable form 2 This is troubling because of the problems associated with osteopenia in neonates Bone mineralization is important for premature infants Rickets and bone fractures are higher in preterm infants than term infants For this reason we are investigating whether there is a connection between PPI therapies specifically Prevacid and decreased bone densities in neonates
The objective is to determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates
Neonates are at a crucial age for bone mineralization Because esophageal reflux is common in neonates PPI therapy is commonly used despite little information on effectiveness and side effects PPIs work by blocking the production of protons in the pumps in the stomach thus making the stomach less acidic The calcium ion needs an acidic environment in order to be broken down from its natural compounds into an absorbable form 2 This is troubling because of the problems associated with osteopenia in neonates Bone mineralization is important for premature infants Rickets and bone fractures are higher in preterm infants than term infants For this reason we are investigating whether there is a connection between PPI therapies specifically Prevacid and decreased bone densities in neonates
The objective is to determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates
Detailed Description:
After a patient is screened and consent is obtained participants will all be initially placed into group one Patients will be later moved to group two if their treatment includes proton pump inhibitors
Group 1 Patients that meet the selection criteria that are not currently receiving any treatments for reflux or have other excluding conditions
Group 2 Patients that meet the selection criteria and are receiving proton pump inhibitors as part of their treatment in the NBICU
Participants in both groups will receive a bone density ultrasound when they begin full feeds and every two weeks following until discharge Participants will not be asked to participate in scans post discharge
Because most babies do not begin GER therapy until some time after they have reached full feedings they will be placed in group two retrospectively
During each participating infants hospital stay the following procedures will be performed
Each infant will undergo all of the tests and procedures that would normally be done for hisher care including physical exams vital signs and monitoring respiratory status
Each infant will be weighed and and hisher length and head circumference will also be measured This is also standard of care
After the initial scan each participating infant will receive subsequent bone density ultrasounds once every two weeks until time of discharge These bone ultrasounds are done by study personnel and will not be charged to the patient or the patients insurance
The medications being evaluated in this study are not experimental Patient care is to the discretion of the treating physician Standard of care and treatment will not be affected by this study The only procedures included in this study that are not a standard of care are bone ultrasounds three weeks apart number of ultrasounds depends on discharge death and other excluding criteria
Group 1 Patients that meet the selection criteria that are not currently receiving any treatments for reflux or have other excluding conditions
Group 2 Patients that meet the selection criteria and are receiving proton pump inhibitors as part of their treatment in the NBICU
Participants in both groups will receive a bone density ultrasound when they begin full feeds and every two weeks following until discharge Participants will not be asked to participate in scans post discharge
Because most babies do not begin GER therapy until some time after they have reached full feedings they will be placed in group two retrospectively
During each participating infants hospital stay the following procedures will be performed
Each infant will undergo all of the tests and procedures that would normally be done for hisher care including physical exams vital signs and monitoring respiratory status
Each infant will be weighed and and hisher length and head circumference will also be measured This is also standard of care
After the initial scan each participating infant will receive subsequent bone density ultrasounds once every two weeks until time of discharge These bone ultrasounds are done by study personnel and will not be charged to the patient or the patients insurance
The medications being evaluated in this study are not experimental Patient care is to the discretion of the treating physician Standard of care and treatment will not be affected by this study The only procedures included in this study that are not a standard of care are bone ultrasounds three weeks apart number of ultrasounds depends on discharge death and other excluding criteria
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