Effect of Early Use of Caffeine Citrate in Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-05

Study Completion Date

2019-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled phase 3 clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Caffeine Citrate

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Caffeine Citrate

Intervention Type DRUG

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

Interventions

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Caffeine Citrate

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

Intervention Type DRUG

Eligibility Criteria

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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).