CaffeineNCT03298347
Caffeine for Preterm Infants With Apnea of Prematurity(AOP)
A study testing 80mg/kg of caffeine and 20mg/kg of caffeine in people with Caffeine and Apnea of Prematurity, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists. Read more about this study
- Who is it for?
- Ages 1 minute to 1 month
- Conditions the study is for
- Caffeine, Apnea of Prematurity
- What is being tested?
- 80mg/kg of caffeine and 20mg/kg of caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Oct 2018
- Phase
- Interventional
- 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 1 minute to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age less than 32 weeks;
- appear AOP;
- parents'consents are obtained.
Who cannot join
- major congenital abnormalities;
- Parents' rejection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Shi Yuan, PhD,MD, 13508300283, petshi530@vip.163.com
About this study
Official title: Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.
Read the detailed description
Less evidences about more dose of caffein used in preterm infants.
- Conditions
- Caffeine, Apnea of Prematurity
- Being tested
- 80mg/kg of caffeine, 20mg/kg of caffeine
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80mg/kg of caffeineDrug
80mg/kg of caffeine is given to treat AOP
20mg/kg of caffeineDrug
20mg/kg of caffeine is given to treat AOP
| Study group | Role | What they receive |
|---|---|---|
| 80mg/kg of caffeine | Experimental | 80mg/kg of caffeine is given to treat AOP. Receives: Drug: 80mg/kg of caffeine |
| 20mg/kg of caffeine | Active comparator | 20mg/kg of caffeine is given to treat AOP. Receives: Drug: 20mg/kg of caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of AOP
AOP appears again in preterm infants
Measured: within 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, MD;PhD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298347
- Sponsor's protocol ID
- 201733
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03298347
- Acronym / sponsor ID
- 201733
- Conditions
- Caffeine, Apnea of Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 2 Oct 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.
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.
Detailed description
Less evidences about more dose of caffein used in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 80mg/kg of caffeine | Experimental | Drug: 80mg/kg of caffeine80mg/kg of caffeine is given to treat AOP. |
| 20mg/kg of caffeine | Active comparator | Drug: 20mg/kg of caffeine20mg/kg of caffeine is given to treat AOP. |
Who may qualify
- Ages
- 1 minute to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age less than 32 weeks;
- appear AOP;
- parents'consents are obtained.
Key exclusion criteria (2 listed)
- major congenital abnormalities;
- Parents' rejection
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 |
|---|---|---|
| 80mg/kg of caffeine80mg/kg of caffeine is given to treat AOP | Drug | 80mg/kg of caffeine |
| 20mg/kg of caffeine20mg/kg of caffeine is given to treat AOP | Drug | 20mg/kg of caffeine |
Primary outcome
the rate of AOP
Time frame: within 100 days
AOP appears again in preterm infants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Shi Yuan, MD;PhD study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 80mg/kg of caffeine and 20mg/kg of caffeine in people with Caffeine and Apnea of Prematurity, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Juan, MD (18680887330, 416767068@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of AOP (time frame: within 100 days). 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 2 Oct 2017.