Caffeine to Reduce Mechanical Ventilation in Preterm Infants
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Purpose
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. Recently the use of Caffeine in ventilated infants has been initiated earlier because of the reported reduction in BPD. However there is paucity of data supporting this practice.
Because protracted mechanical ventilation and supplemental oxygen increase the risk of developing BPD, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of early Caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial.
Hypothesis:
The primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of BPD.
Objective:
The objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of BPD.
Study Design:
This will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial.
Population:
Premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. Infants with major congenital anomalies or small for gestational age will be excluded.
Methods:
Infants will be randomized within the first 5 days to receive a study drug consisting of either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline). Infants will continue to receive the study drug until the first elective extubation.
| Condition | Intervention |
|---|---|
|
Prematurity Apnea Respiratory Failure |
Drug: Caffeine citrate Other: Normal saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants |
- Time to first elective extubation [ Time Frame: From the time of first intubation until the first elective extubation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
- Survival [ Time Frame: From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death ] [ Designated as safety issue: Yes ]
- Total duration of mechanical ventilation [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
- Total duration of oxygen supplementation [ Time Frame: From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age ] [ Designated as safety issue: No ]
- Bronchopulmonary dysplasia (BPD) [ Time Frame: Evaluated at 36 weeks corrected postmenstrual age ] [ Designated as safety issue: No ]BPD defined as oxygen dependence at 36 weeks post-menstrual age and by physiological test, severe BPD defined as requirement for oxygen FiO2 > 0.3 at 36 weeks post menstrual age or need for positive pressure support.
- Survival without BPD [ Time Frame: From the time of randomization until 36 weeks corrected age, discharge or death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Caffeine Arm
Subjects randomized to this arm will receive blinded Caffeine citrate.
|
Drug: Caffeine citrate
Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate. Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug. After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team. Infants will continue to receive the study drug until 12 hours prior to the first elective extubation. |
|
Placebo Comparator: Placebo Arm
Subjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
|
Other: Normal saline
Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline). Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug. After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team. Infants will continue to receive the study drug until 12 hours prior to the first elective extubation. |
Eligibility| Ages Eligible for Study: | up to 5 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Premature neonates born between 23 and 30 completed weeks of gestation.
- Requiring mechanical ventilation within the first 5 postnatal days
- Written-informed parental consent for the study
Exclusion Criteria:
- Major congenital anomalies
- Small for gestational age
Contacts and Locations| Contact: Eduardo Bancalari, M.D. | 3055856408 | ebancalari@miami.edu |
| Contact: Carmen Dugard, R.R.T. | 3055856408 | cdugard@med.miami.edu |
| United States, Florida | |
| NICU, Holtz Children's Hospital, Jackson Health System | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Carmen D'Ugard, R.R.T. 305-585-6408 cdugard@med.miami.edu | |
| Principal Investigator: Eduardo Bancalari, M.D. | |
| Principal Investigator: Nelson Claure, M.Sc., Ph.D. | |
| Principal Investigator: | Eduardo Bancalari, M.D. | University of Miami |
| Principal Investigator: | Nelson Claure, M.Sc., Ph.D. | University of Miami |
More Information
No publications provided
| Responsible Party: | Eduardo Bancalari, Professor, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01751724 History of Changes |
| Other Study ID Numbers: | 20120786 |
| Study First Received: | December 12, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by University of Miami:
|
Premature infants Caffeine Methylxanthines Mechanical ventilation |
Oxygen Weaning Bronchopulmonary dysplasia |
Additional relevant MeSH terms:
|
Apnea Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Caffeine Caffeine citrate Central Nervous System Stimulants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 22, 2013