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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06097767

Enrollment

Registered

2023-10-24

Start date

2023-10-19

Completion date

2024-07-30

Last updated

2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological Action of Drug

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.

Interventions

DRUGCaffeine 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.

DRUGAmikacin

it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

32 Weeks to 35 Weeks

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
decreasing NEC rates	1 year	decreasing NEC rates and stage ≥2 and death.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026