Proton Pump Inhibitor Therapy and Bone Density in Premature Infants

NCT00888017 | Terminated

• 1 other identifier: 29104
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteopenia; Prematurity

Keywords

bone density; proton pump inhibitors; premature infants

Outcome Measures

Primary Outcomes (1)

• To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.

  18 months

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• Ivanovich P, Fellows H, Rich C. The absorption of calcium carbonate. Ann Intern Med. 1967 May;66(5):917-23. doi: 10.7326/0003-4819-66-5-917. No abstract available.

  PMID: 6025232 BACKGROUND

• Yang YX, Lewis JD, Epstein S, Metz DC. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006 Dec 27;296(24):2947-53. doi: 10.1001/jama.296.24.2947.

  PMID: 17190895 RESULT

MeSH Terms

Conditions

Bone Diseases, Metabolic; Premature Birth

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gary M Chan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)