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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00888017
First received: April 8, 2009
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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.


Condition
Osteopenia
Prematurity

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Proton Pump Inhibitor Therapy and Bone Density in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888017

Locations
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Gary M Chan, MD University of Utah
  More Information

Publications:
Responsible Party: Gary M Chan, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00888017     History of Changes
Other Study ID Numbers: 29104
Study First Received: April 8, 2009
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
bone density
proton pump inhibitors
premature infants

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014