Caffeine to Reduce Mechanical Ventilation in Preterm Infants

Respiratory Failure Clinical Trial

Official title:

Use of Caffeine to Reduce Length of Mechanical Ventilation in Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01751724
• Other study ID #: 20120786
• Status: Terminated
• Phase: N/A
• First received: December 12, 2012
• Last updated: August 29, 2016
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Prematurity
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

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.

Locations

Country	Name	City	State
United States	NICU, Holtz Children's Hospital, Jackson Health System	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first elective extubation		From the time of first intubation until the first elective extubation, up to 36 weeks corrected age	No
Secondary	Survival		From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death	Yes
Secondary	Total duration of mechanical ventilation		From the time of first intubation until the last extubation, up to 36 weeks corrected age	No
Secondary	Total duration of oxygen supplementation		From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age	No
Secondary	Bronchopulmonary dysplasia (BPD)	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.	Evaluated at 36 weeks corrected postmenstrual age	No
Secondary	Survival without BPD		From the time of randomization until 36 weeks corrected age, discharge or death	No