Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | April 2009 |
| End Date: | April 2013 |
Previous research studies have shown that there may be a connection between proton pump
inhibitor therapies and hip fracture in adults(1). Proton pump inhibitor(PPI) reflux
medications raise the pH of the stomach, which may effect the body's 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.
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 infant's hospital stay, the following procedures will be
performed:
Each infant will undergo all of the tests and procedures that would normally be done for
his/her care including physical exams, vital signs, and monitoring respiratory status.
Each infant will be weighed and and his/her 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 patient's 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).
Inclusion Criteria:
- Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight
Parental consent has been obtained
Exclusion Criteria:
- Infants with bone disorders, liver or kidney problems, infants of diabetics, growth
retarded infants, or infants taking diuretics or chronic steroids will be excluded.
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