Effect of Early Use of Caffeine Citrate in Preterm Neonates

Phase 3

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Caffeine Citrate

• Registration Number: NCT04001712
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-04-05
• Primary Completion: 2019-05-05
• Status Verified: 2019-06
• Study Completion: 2019-06-10
• Study First Submitted: 2019-06-22
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
late caffeine citrate group	Caffeine Citrate	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
early caffeine citrate group	Caffeine Citrate	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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Al Qahirah, Egypt