NCT06097767

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 32 Weeks – 35 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Pharmacological Action of Drug

Interventions

Type	Name	Description
DRUG	Caffeine citrate	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.
DRUG	Amikacin	it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-04-01
• Completion: 2024-07-30
• First posted: 2023-10-24
• Last updated: 2023-10-24

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study