This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Caffeine to Reduce Mechanical Ventilation in Preterm Infants

This study has been terminated.
(Safety)
Sponsor:
Information provided by (Responsible Party):
Eduardo Bancalari, University of Miami
ClinicalTrials.gov Identifier:
NCT01751724
First received: December 12, 2012
Last updated: May 17, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Eduardo Bancalari, University of Miami:

Primary Outcome Measures:
  • Age at First Successful Extubation [ Time Frame: From birth to until 36 weeks postmenstrual age ]
    Defined as age of extubation with infant remaining extubated for more than 24 hours.


Secondary Outcome Measures:
  • Survival [ Time Frame: From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death ]
  • Total Duration of Mechanical Ventilation [ Time Frame: From the time of first intubation until the last extubation, up to 36 weeks corrected age ]
  • 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 ]
  • Number of Infants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: Evaluated at 36 weeks corrected postmenstrual age ]
    BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.

  • Survival Without BPD [ Time Frame: From the time of randomization until 36 weeks corrected age, discharge or death ]
    Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.


Other Outcome Measures:
  • Number of Infants With Pulmonary Hemorrhage [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
  • Number of Infants With Necrotizing Enterocolitis [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
  • Number of Infants With Septicemia [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Septicemia defined as positive blood culture

  • Number of Infants With Severe Intraventricular Hemorrhage [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Severe intraventricular hemorrhage defined as grade III or higher

  • Number of Infants With Severe Retinopathy of Prematurity [ Time Frame: From enrollment until 36 weeks postmenstrual age, discharge or death ]
    Severe retinopathy of prematurity defined as stage 3 or higher


Enrollment: 87
Study Start Date: December 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (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   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751724

Locations
United States, Florida
NICU, Holtz Children's Hospital, Jackson Health System
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Eduardo Bancalari, M.D. University of Miami
Principal Investigator: Nelson Claure, M.Sc., Ph.D. University of Miami
  More Information

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
Results First Received: February 28, 2017
Last Updated: May 17, 2017

Keywords provided by Eduardo Bancalari, University of Miami:
Premature infants
Caffeine
Methylxanthines
Mechanical ventilation
Oxygen
Weaning
Bronchopulmonary dysplasia

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Citric Acid
Caffeine
Caffeine citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 19, 2017