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

Al-Azhar University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Pharmacological Action of Drug

Treatments: Drug: Caffeine citrate; Drug: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT06097767

RHDIRB2018122001/2116

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 32 to 35 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control group

Other group

Description:

It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS

Treatment:

Drug: Amikacin

Caffeine-treated group

Active Comparator group

Description:

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.

Treatment:

Drug: Caffeine citrate