Effect of Early Use of Caffeine Citrate in Preterm Neonates

Preterm Birth Clinical Trial

Official title:

Effect of Early Use of Caffeine Citrate in Preterm Neonates Needing Respiratory Support.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001712
• Other study ID #: early caffeine in preterm
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2019
• Est. completion date: June 10, 2019

Study information

• Verified date: June 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 10, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Caffeine Citrate
caffeine citrate is given early to preterm neonates in need of respiratory support

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Lista G, Fabbri L, Polackova R, Kiechl-Kohlendorfer U, Papagaroufalis K, Saenz P, Ferrari F, Lasagna G, Carnielli VP; Peyona® 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. — View 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. — View Citation

Rivera-Oliver M, Díaz-Ríos 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of