the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
NCT ID: NCT06097767
Last Updated: 2023-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2023-10-19
2024-07-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Control group
It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS
Amikacin
it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group
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.
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.
Interventions
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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.
Amikacin
it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Major congenital anomalies
* spontaneous intestinal perforation
* Endocrinal Dysfunctions
32 Weeks
35 Weeks
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Gellan Alaa Mohamed Kamel Morsy
Lecturer of pharmacology and toxicology
Locations
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NICU at Alzahraa University Hospital
Cairo, , Egypt
Countries
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Other Identifiers
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RHDIRB2018122001/2116
Identifier Type: -
Identifier Source: org_study_id
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