Osteopenia (Disorder)NCT03084432
Effect of Caffeine on Preterm Infants' Bone Mineral Content
An observational study of Osteopenia (Disorder) and Apnea of Prematurity, run by Ain Shams University.
Trial summary
The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteopenia (Disorder), Apnea of Prematurity
- What is being tested?
- Dual Energy X-ray Absorptiometry
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 1 Sep 2016
- 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: preterm neonates
Who may be able to join
- Preterm infants with gestational age of 34 weeks or less consecutively admitted to the neonatal intensive care unit
Who cannot join
- Renal or endocrinal diseases Congenital anomalies Suspected chromosomal aberrations Receiving diuretics or steroid therapy
About this study
Official title: Assessment of Bone Mineral Content for Preterm Neonates Treated With Caffeine Using Dual Energy X-ray Absorptiometry : an Observational Study
The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture.
- Conditions
- Osteopenia (Disorder), Apnea of Prematurity
- Being tested
- Dual Energy X-ray Absorptiometry
- Keywords
- caffeine, bone mineral content
- Medical subject headings
- Bone Diseases, Metabolic, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy X-ray AbsorptiometryDiagnostic test
Dual Energy X-ray Absorptiometry done for both studied groups
| Study group | Role | What they receive |
|---|---|---|
| caffeine group | 22 preterm infants received caffeine (starting from day 2 of life and received for more than 7 days) for apnea prophylaxis or treatment according to protocol of Ain Shams University neonatal intensive care unit [apnea prophylaxis for preterm ≤32 weeks gestation and apnea treatment for those 33 or 34 weeks gestation]. Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age Receives: Diagnostic Test: Dual Energy X-ray Absorptiometry | |
| control group | 20 preterm infants for whom caffeine was not given, either it was not indicated, not available or parents refused its use.Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age Receives: Diagnostic Test: Dual Energy X-ray Absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry
Whole Body Scanner, Pencil beam, regions: antro-posterior Spine, Lateral, Hip, Forearm/ Hand, Ortho Femur Speed: Up To 76mm Per Sec., Scan Times (min): antro-posterior Spine-2, Lateral-12, Hip-4, Forearm-1, Femur-4 Pentium II Computer System, Windows O/S, Lunar Software 15" Hi-Resolution Monitor, Auto Centering Laser Guide, Data Analysis: Auto Analysis Software, Smart Scan, Auto Position. Weight and length were measured and recorded. During the scan an infant was placed on the scanning table with the head at the marked start line, assuring that the position was the same for all subjects. The study was carried out with the infants sleeping without sedation. The infants were placed supine and were restrained with a cotton blanket. To induce sleep, infants were fed a few minutes prior to the study. When image quality was poor due to movement of the infant or to other causes the measurement at that time point was not included for analysis.
Measured: 5-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Dec 2014
- Primary completion1 Jun 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopenia (Disorder)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ismail, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084432
- Sponsor's protocol ID
- 16246
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Mineral Content for Preterm Neonates Treated With Caffeine Using Dual Energy X-ray Absorptiometry : an Observational Study
- ClinicalTrials.gov ID
- NCT03084432
- Acronym / sponsor ID
- 16246
- Conditions
- Osteopenia (Disorder), Apnea of Prematurity
- Keywords
- caffeine, bone mineral content
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caffeine group | – | Diagnostic Test: Dual Energy X-ray Absorptiometry22 preterm infants received caffeine (starting from day 2 of life and received for more than 7 days) for apnea prophylaxis or treatment according to protocol of Ain Shams University neonatal intensive care unit [apnea prophylaxis for preterm ≤32 weeks gestation and apnea treatment for those 33 or 34 weeks gestation]. Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age |
| control group | – | Diagnostic Test: Dual Energy X-ray Absorptiometry20 preterm infants for whom caffeine was not given, either it was not indicated, not available or parents refused its use.Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- preterm neonates
Key inclusion criteria (1 listed)
- Preterm infants with gestational age of 34 weeks or less consecutively admitted to the neonatal intensive care unit
Key exclusion criteria (1 listed)
- Renal or endocrinal diseases Congenital anomalies Suspected chromosomal aberrations Receiving diuretics or steroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Energy X-ray AbsorptiometryDual Energy X-ray Absorptiometry done for both studied groups | Diagnostic test | caffeine group, control group |
Primary outcome
effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry
Time frame: 5-6 weeks
Whole Body Scanner, Pencil beam, regions: antro-posterior Spine, Lateral, Hip, Forearm/ Hand, Ortho Femur Speed: Up To 76mm Per Sec., Scan Times (min): antro-posterior Spine-2, Lateral-12, Hip-4, Forearm-1, Femur-4 Pentium II Computer System, Windows O/S, Lunar Software 15" Hi-Resolution Monitor, Auto Centering Laser Guide, Data Analysis: Auto Analysis Software, Smart Scan, Auto Position. Weight and length were measured and recorded. During the scan an infant was placed on the scanning table with the head at the marked start line, assuring that the position was the same for all subjects. The study was carried out with the infants sleeping without sedation. The infants were placed supine and were restrained with a cotton blanket. To induce sleep, infants were fed a few minutes prior to the study. When image quality was poor due to movement of the infant or to other causes the measurement at that time point was not included for analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenia (Disorder) and Apnea of Prematurity, run by Ain Shams University.
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: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry (time frame: 5-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.