the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Study Details
Study Description
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 :
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Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS |
Drug: Amikacin
it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group
|
Active Comparator: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- decreasing NEC rates [1 year]
decreasing NEC rates and stage ≥2 and death.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All preterm infants with respiratory distress syndrome.
Exclusion Criteria:
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Preterm admitted to NICU for other reasons rather than respiratory distress
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Major congenital anomalies
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spontaneous intestinal perforation
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Endocrinal Dysfunctions
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | NICU at Alzahraa University Hospital | Cairo | Egypt |
Sponsors and Collaborators
- Al-Azhar University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RHDIRB2018122001/2116