OsteopeniaPPINCT00888017
Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
An observational study of Osteopenia and Prematurity, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteopenia, Prematurity
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight.
Who may be able to join
- Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight Parental consent has been obtained
Who cannot join
- Infants with bone disorders, liver or kidney problems, infants of diabetics, growth retarded infants, or infants taking diuretics or chronic steroids will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
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.
Read the 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).
- Conditions
- Osteopenia, Prematurity
- Keywords
- bone density, proton pump inhibitors, premature infants
- Medical subject headings
- Bone Diseases, Metabolic, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Gary M Chan, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888017
- Sponsor's protocol ID
- 29104
- Acronym
- PPI
- Status last verified
- Jan 2013
- First submitted
- 8 Apr 2009
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6025232Yang 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.
PubMed 17190895
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitor Therapy and Bone Density in Premature Infants
- ClinicalTrials.gov ID
- NCT00888017
- Acronym / sponsor ID
- PPI / 29104
- Conditions
- Osteopenia, Prematurity
- Keywords
- bone density, proton pump inhibitors, premature infants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight.
Key inclusion criteria (1 listed)
- Infants born between 24 and 34 weeks gestation and 600g to 2000g birth weight Parental consent has been obtained
Key exclusion criteria (1 listed)
- Infants with bone disorders, liver or kidney problems, infants of diabetics, growth retarded infants, or infants taking diuretics or chronic steroids will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Background: PubMed 6025232Ivanovich 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.
- Results publication: PubMed 17190895Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary M Chan, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenia and Prematurity, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if a connection exists between proton pump inhibitor antacids and decreased rate of bone mineralization in neonates. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.