Early Versus Routine Caffeine Administration in Extremely Preterm Neonates (DRCAFFEINE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sharp HealthCare
Sponsor:
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare
ClinicalTrials.gov Identifier:
NCT01783561
First received: January 31, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Caffeine
Drug: Caffeine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

Resource links provided by NLM:


Further study details as provided by Sharp HealthCare:

Primary Outcome Measures:
  • Intubation [ Time Frame: First 12 hours of life ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • hypotension [ Time Frame: first 12 hours of life ] [ Designated as safety issue: No ]
    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 volume replacement or pressors for hypotension within the first 12 hours of life.

  • systemic blood flow [ Time Frame: first 24 hours ] [ Designated as safety issue: No ]
    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)

  • Cerebral blood flow [ Time Frame: first 24 hours of life ] [ Designated as safety issue: No ]
    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 cerebral blood flow by near infrared spectroscopy (NIRS) in the first 24 hours of life.


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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 30 minutes 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:
  • caffeine citrate
  • IV caffeine
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.
Drug: 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 30 minutes 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:
  • caffeine citrate
  • IV caffeine

Detailed Description:

The primary aim of our study is to compare the respiratory 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. Secondary aims include detailing the acute hemodynamic effects of caffeine and comparing the hemodynamic effects of receiving caffeine . These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any infant delivered at University of California, San Diego 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.
  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: NCT01783561

Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92103
Contact: Kathy Arnell, RN    858-939-4966    kathy.arnell@sharp.com   
Contact: Wade Rich, RRT       wade.rich@sharp.com   
Principal Investigator: Anup Katheria, MD         
Sponsors and Collaborators
Sharp HealthCare
Investigators
Principal Investigator: Anup Katheria, MD Sharp HealthCare
  More Information

No publications provided

Responsible Party: Anup Katheria, M.D., Director of Neonatal Research, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT01783561     History of Changes
Other Study ID Numbers: 2HRCAFFEINE
Study First Received: January 31, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sharp HealthCare:
caffeine
intubation

Additional relevant MeSH terms:
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 July 24, 2014