Clinical trial NCT04001712: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Keywords: early caffeine preterm
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 54
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled phase 3 clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: duration of respiratory support in preterm neonates receiving early caffeine citrate
timeFrame: throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Bassem El Sayed
role: STUDY_CHAIR
affiliation: Medical Military Academy
name: Sameh Amer
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Hisham Awad
role: STUDY_DIRECTOR
References:
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.
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.
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.