- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783561
Early Versus Routine Caffeine Administration in Extremely Preterm Neonates (EARLYCAFFEINE)
November 26, 2018 updated by: Anup Katheria, M.D., Sharp HealthCare
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92103
- Sharp Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: early caffeine
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.
|
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.
Other Names:
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Placebo Comparator: Routine 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.
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
First 12 hours of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Requiring Inotropes in the First 24 Hours
Time Frame: first 24 hours of life
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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.
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first 24 hours of life
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Systemic Blood Flow
Time Frame: first 24 hours
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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)
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first 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anup Katheria, MD, Sharp HealthCare
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
January 31, 2013
First Submitted That Met QC Criteria
January 31, 2013
First Posted (Estimate)
February 5, 2013
Study Record Updates
Last Update Posted (Actual)
December 11, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2HRCAFFEINE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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