Back to resultsthe Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Primary Purpose
Pharmacological Action of Drug
Status
Active
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Caffeine citrate
Amikacin
Sponsored by
About this trial
This is an interventional treatment trial for Pharmacological Action of Drug
Eligibility Criteria
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
Sites / Locations
- NICU at Alzahraa University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Control group
Caffeine-treated group
Arm Description
It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS
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.
Outcomes
Primary Outcome Measures
decreasing NEC rates
decreasing NEC rates and stage ≥2 and death.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06097767
Brief Title
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Official Title
Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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 :
Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacological Action of Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS
Arm Title
Caffeine-treated group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Caffeine citrate
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Amikacin
Intervention Description
it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group
Primary Outcome Measure Information:
Title
decreasing NEC rates
Description
decreasing NEC rates and stage ≥2 and death.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NICU at Alzahraa University Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
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