Proton Pump Inhibitor Therapy and Bone Density in Premature Infants

Stopped early

Conditions studied: Osteopenia, Prematurity

In brief

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.

Key facts

Study ID

NCT00888017

Run by

University of Utah

People needed

10

Starts

2009-04-01

Expected to finish

2013-01-01

Last updated by the study team

2013-01-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight Parental consent has been obtained

You may not qualify if…

• Infants with bone disorders, liver or kidney problems, infants of diabetics, growth retarded infants, or infants taking diuretics or chronic steroids will be excluded.

Where it is running

• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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