CaffeinePhase 4EARLYCAFFEINENCT01783561
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
A Phase 4 study testing Caffeine in people with Caffeine, run by Sharp HealthCare at 1 site in United States.
Trial summary
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caffeine
- What is being tested?
- Caffeine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation
Who cannot join
- Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
- Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
- Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Memorial Hospital
San Diego, California, 92103
About this study
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.
Read the detailed description
This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants <29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.
- Conditions
- Caffeine
- Being tested
- Caffeine
- Keywords
- caffeine, intubation, hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called caffeine citrate, IV caffeine
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
| Study group | Role | What they receive |
|---|---|---|
| early caffeine | Active comparator | Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life. Receives: Drug: Caffeine |
| Routine caffeine | Placebo comparator | Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life. Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation
The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.
Measured: First 12 hours of life
Secondary outcomes (2)
Subjects Requiring Inotropes in the First 24 Hours
To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for inotropes for hypotension within the first 24 hours of life.
Measured: first 24 hours of life
Systemic Blood Flow
To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783561
- Sponsor's protocol ID
- 2HRCAFFEINE
- Acronym
- EARLYCAFFEINE
- Status last verified
- Nov 2018
- First submitted
- 31 Jan 2013
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
- ClinicalTrials.gov ID
- NCT01783561
- Acronym / sponsor ID
- EARLYCAFFEINE / 2HRCAFFEINE
- Conditions
- Caffeine
- Keywords
- caffeine, intubation, hemodynamic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.
Detailed description
This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants <29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early caffeine | Active comparator | Drug: CaffeineInfants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life. |
| Routine caffeine | Placebo comparator | Drug: CaffeineInfants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation
Key exclusion criteria (3 listed)
- Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
- Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
- Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
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 |
|---|---|---|
| CaffeineAlso: caffeine citrate, IV caffeineInfants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose. | Drug | Routine caffeine, early caffeine |
Primary outcome
Intubation
Time frame: First 12 hours of life
The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.
2 secondary outcomes
Subjects Requiring Inotropes in the First 24 Hours
Time frame: first 24 hours of life
Systemic Blood Flow
Time frame: first 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anup Katheria, MD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine in people with Caffeine, run by Sharp HealthCare 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 3 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 11 Dec 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intubation (time frame: First 12 hours of life). 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 11 Dec 2018.