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Effect of Early Use of Caffeine Citrate in Preterm Neonates

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ToestandVoltooid
Sponsors
Ain Shams University

Sleutelwoorden

Abstract

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.

Omschrijving

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.

Datums

Laatst geverifieerd: 05/31/2019
Eerste ingediend: 06/21/2019
Geschatte inschrijving ingediend: 06/25/2019
Eerst geplaatst: 06/27/2019
Laatste update ingediend: 06/27/2019
Laatste update geplaatst: 07/01/2019
Werkelijke startdatum van het onderzoek: 04/04/2019
Geschatte primaire voltooiingsdatum: 05/04/2019
Geschatte voltooiingsdatum van het onderzoek: 06/09/2019

Conditie of ziekte

Preterm Birth

Interventie / behandeling

Drug: Caffeine Citrate

Fase

Fase 3

Armgroepen

ArmInterventie / behandeling
Experimental: early caffeine citrate group
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
Active Comparator: late caffeine citrate group
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

Geschiktheidscriteria

Geslachten die in aanmerking komen voor studieAll
Accepteert gezonde vrijwilligersJa
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

Resultaat

Primaire uitkomstmaten

1. duration of respiratory support in preterm neonates receiving early caffeine citrate [throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of]

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.

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