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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06097767
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.4
• Patients Per Site Per Month: 5.3

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 :

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacological Action of Drug	Drug: Caffeine citrate; Drug: Amikacin	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
• Actual Study Start Date: Oct 19, 2023
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Jul 30, 2024

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

1. decreasing NEC rates [1 year]

   decreasing NEC rates and stage ≥2 and death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 32 Weeks to 35 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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.

• Responsible Party: Gellan Alaa Mohamed Kamel Morsy, Lecturer of pharmacology and toxicology, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT06097767
• Other Study ID Numbers: RHDIRB2018122001/2116
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 24, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Amikacin; Caffeine; Caffeine citrate

Study Results

No Results Posted as of Oct 24, 2023