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

Early Phase 1

Active, not recruiting

• Conditions: Pharmacological Action of Drug
• Interventions: Drug: Amikacin; Drug: Caffeine citrate

• Registration Number: NCT06097767
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-18
• Last Update Submitted: 2023-10-18
• Study Start: 2023-10-19
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All preterm infants with respiratory distress syndrome.

Exclusion Criteria

• Preterm admitted to NICU for other reasons rather than respiratory distress
• Major congenital anomalies
• spontaneous intestinal perforation
• Endocrinal Dysfunctions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control group	Amikacin	It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS
Caffeine-treated group	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.

Primary Outcome Measures

Name	Time	Method
decreasing NEC rates	1 year	decreasing NEC rates and stage ≥2 and death.

Trial Locations

Locations (1)

NICU at Alzahraa University Hospital; 🇪🇬 Cairo, Egypt