Effect of Early Use of Caffeine Citrate in Preterm Neonates

Ain Shams University54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Preterm Birth

Interventions

Caffeine CitrateDRUG

caffeine citrate is given early to preterm neonates in need of respiratory support

Eligibility

Sex: ALLMax age: 24 Hours

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of

Data from ClinicalTrials.gov

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