drugset
drugset / Trial / NCT06097767

the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

NCT06097767 ↗

Phase 0 Unknown 50 enrolled Al-Azhar University
RandomizedSingle-groupOpen-labelTreatment

Summary

It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome. The purpose of this study is to : 1. Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants. 2. Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care 1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks. 2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.

Timeline

Start
2023-10-19
Primary completion
2024-04-01
Completion
2024-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Caffeine Small molecule 60 mg Intravenous
Background Amikacin Small molecule — —

Indications

No indication recorded.