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Effect of Early Use of Caffeine Citrate in Preterm Neonates

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Caffeine Citrate
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring early caffeine preterm

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Preterm neonates ≤ 33 weeks gestational age.
  2. Preterm neonates who need respiratory support (either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation).

Exclusion Criteria:

  1. Neonate>33 wks gestational age.
  2. Neonates on room air.
  3. Neonates with major congenital or cardiac anomalies

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early caffeine citrate group

late caffeine citrate group

Arm Description

preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate upon start of the respiratory support Caffeine citrate was given at a loading dose of 10 mg/kg and with a daily maintenance dose of 5 mg/kg until the patient was off respiratory support

preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate 6 hours before weaning of respiratory support

Outcomes

Primary Outcome Measures

duration of respiratory support in preterm neonates receiving early caffeine citrate
preterm neonates of gestational age 33 weeks or less needing any respiratory support (CPAP , mechanical ventilation....)were given caffeine citrate at the start of the support. duration of the support was compared to the duration of respiratory support in the other arm that includes preterm neonates of gestational age 33 weeks or less needing any respiratory support and receiving caffeine citrate 6 hours before weaning only.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2019
Last Updated
June 28, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04001712
Brief Title
Effect of Early Use of Caffeine Citrate in Preterm Neonates
Official Title
Effect of Early Use of Caffeine Citrate in Preterm Neonates Needing Respiratory Support.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This work is designed to study the effect of the early use of caffeine citrate in preterm neonates who need respiratory support on morbidity and short term neonatal outcome.
Detailed Description
Caffeine citrate is one of the most widely used drugs in neonatal intensive care units. It is a respiratory stimulant which has well established therapeutic effects in apnea and facilitation of extubation. Caffeine is an adenosine antagonist ; it blocks selectively A2 receptors and non selective blocks A1 receptors. Its effects include improved lung compliance, minute ventilation, respiratory muscle contractility, increased sensitivity to carbon dioxide, enhanced catecholamine activity and decreased airway resistance Early caffeine therapy was associated with a shorter duration of respiratory support and reduction in bronchopulmonary dysplasia , cerebral palsy, patent ductus arteriosis ligation, intracranial hemorrhage, apnea and death Despite its widespread use, information regarding optimal time to initiate therapy and appropriate time to discontinue therapy is limited. Recent studies have indicated that early initiation of caffeine therapy is associated with improved neonatal outcomes Little is known about the early use of caffeine citrate in preterm neonates. The investigators aim to explore the effectiveness of its very early use in reducing the duration of respiratory support.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
early caffeine preterm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled phase 3 clinical trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early caffeine citrate group
Arm Type
Experimental
Arm Description
preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate upon start of the respiratory support Caffeine citrate was given at a loading dose of 10 mg/kg and with a daily maintenance dose of 5 mg/kg until the patient was off respiratory support
Arm Title
late caffeine citrate group
Arm Type
Active Comparator
Arm Description
preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate 6 hours before weaning of respiratory support
Intervention Type
Drug
Intervention Name(s)
Caffeine Citrate
Intervention Description
caffeine citrate is given early to preterm neonates in need of respiratory support
Primary Outcome Measure Information:
Title
duration of respiratory support in preterm neonates receiving early caffeine citrate
Description
preterm neonates of gestational age 33 weeks or less needing any respiratory support (CPAP , mechanical ventilation....)were given caffeine citrate at the start of the support. duration of the support was compared to the duration of respiratory support in the other arm that includes preterm neonates of gestational age 33 weeks or less needing any respiratory support and receiving caffeine citrate 6 hours before weaning only.
Time Frame
throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm neonates ≤ 33 weeks gestational age. Preterm neonates who need respiratory support (either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation). Exclusion Criteria: Neonate>33 wks gestational age. Neonates on room air. Neonates with major congenital or cardiac anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassem El Sayed
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sameh Amer
Organizational Affiliation
Medical Military Academy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hisham Awad
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
1825
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26820884
Citation
Lista G, Fabbri L, Polackova R, Kiechl-Kohlendorfer U, Papagaroufalis K, Saenz P, Ferrari F, Lasagna G, Carnielli VP; Peyona(R) PASS Group. The Real-World Routine Use of Caffeine Citrate in Preterm Infants: A European Postauthorization Safety Study. Neonatology. 2016;109(3):221-7. doi: 10.1159/000442813. Epub 2016 Jan 28.
Results Reference
background
PubMed Identifier
25402629
Citation
Lodha A, Seshia M, McMillan DD, Barrington K, Yang J, Lee SK, Shah PS; Canadian Neonatal Network. Association of early caffeine administration and neonatal outcomes in very preterm neonates. JAMA Pediatr. 2015 Jan;169(1):33-8. doi: 10.1001/jamapediatrics.2014.2223.
Results Reference
background
PubMed Identifier
24530739
Citation
Rivera-Oliver M, Diaz-Rios M. Using caffeine and other adenosine receptor antagonists and agonists as therapeutic tools against neurodegenerative diseases: a review. Life Sci. 2014 Apr 17;101(1-2):1-9. doi: 10.1016/j.lfs.2014.01.083. Epub 2014 Feb 13.
Results Reference
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Effect of Early Use of Caffeine Citrate in Preterm Neonates

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