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

NCT06097767 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
32 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-04-01
Completion
2024-07-30
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097767 on ClinicalTrials.gov