Proton Pump Inhibitor Therapy and Bone Density in Premature Infants (PPI)

January 22, 2013 updated by: University of Utah

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.

Study Overview

Status

Terminated

Conditions

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 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).

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

Cohorts and Interventions

Group / Cohort
PPI group
This group of infants have received treatment with a PPI as ordered by their neonatologist during their hospital stay.
non-PPI group
These infants did not receive PPIs during their hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Gary M Chan, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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