Study Stopped
Safety
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants
1 other identifier
interventional
87
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 12, 2012
CompletedFirst Posted
Study publicly available on registry
December 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
June 19, 2017
CompletedJune 19, 2017
May 1, 2017
3.1 years
December 12, 2012
February 28, 2017
May 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Age at First Successful Extubation
Defined as age of extubation with infant remaining extubated for more than 24 hours.
From birth to until 36 weeks postmenstrual age
Secondary Outcomes (5)
Survival
From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death
Total Duration of Mechanical Ventilation
From the time of first intubation until the last extubation, up to 36 weeks corrected age
Total Duration of Oxygen Supplementation
From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age
Number of Infants With Bronchopulmonary Dysplasia (BPD)
Evaluated at 36 weeks corrected postmenstrual age
Survival Without BPD
From the time of randomization until 36 weeks corrected age, discharge or death
Other Outcomes (5)
Number of Infants With Pulmonary Hemorrhage
From enrollment until 36 weeks postmenstrual age, discharge or death
Number of Infants With Necrotizing Enterocolitis
From enrollment until 36 weeks postmenstrual age, discharge or death
Number of Infants With Septicemia
From enrollment until 36 weeks postmenstrual age, discharge or death
- +2 more other outcomes
Study Arms (2)
Caffeine Arm
EXPERIMENTALSubjects randomized to this arm will receive blinded Caffeine citrate.
Placebo Arm
PLACEBO COMPARATORSubjects randomized to this arm will receive blinded Placebo (equivalent volume of normal saline).
Interventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Major congenital anomalies
- Small for gestational age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU, Holtz Children's Hospital, Jackson Health System
Miami, Florida, 33136, United States
Related Publications (1)
Amaro CM, Bello JA, Jain D, Ramnath A, D'Ugard C, Vanbuskirk S, Bancalari E, Claure N. Early Caffeine and Weaning from Mechanical Ventilation in Preterm Infants: A Randomized, Placebo-Controlled Trial. J Pediatr. 2018 May;196:52-57. doi: 10.1016/j.jpeds.2018.01.010. Epub 2018 Mar 6.
PMID: 29519541DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eduardo Bancalari M.D., Director Division of Neonatology
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Bancalari, M.D.
University of Miami
- PRINCIPAL INVESTIGATOR
Nelson Claure, M.Sc., Ph.D.
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 12, 2012
First Posted
December 18, 2012
Study Start
December 1, 2012
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
June 19, 2017
Results First Posted
June 19, 2017
Record last verified: 2017-05