Effect of Early Use of Caffeine Citrate in Preterm Neonates

Study Overview
=================
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.

Official Title
-----------------
Effect of Early Use of Caffeine Citrate in Preterm Neonates Needing Respiratory Support.

Conditions
-----------------
Preterm Birth

Intervention / Treatment
-----------------
* Drug: Caffeine Citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm neonates ≤ 33 weeks gestational age. Preterm neonates who need respiratory support (either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation). Exclusion Criteria: Neonate>33 wks gestational age. Neonates on room air. Neonates with major congenital or cardiac anomalies

Ages Eligible for Study
-----------------
Maximum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled phase 3 clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early caffeine citrate group<br>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 | Drug: Caffeine Citrate<br>* caffeine citrate is given early to preterm neonates in need of respiratory support<br>|
| Active Comparator: late caffeine citrate group<br>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 | Drug: Caffeine Citrate<br>* caffeine citrate is given early to preterm neonates in need of respiratory support<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early caffeine preterm