Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06097767
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Sponsor:
Al-Azhar University
Organization:
Study Overview
Official Title:
Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 :
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: