NCT06097767

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. 1.Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
  2. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 13, 2023

Last Update Submit

October 18, 2023

Conditions

Pharmacological Action of Drug

Outcome Measures

Primary Outcomes (1)

  • decreasing NEC rates

    decreasing NEC rates and stage ≥2 and death.

    1 year

Study Arms (2)

Control group

OTHER

It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS

Drug: Amikacin

Caffeine-treated group

ACTIVE COMPARATOR

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

Interventions

Caffeine citrateDRUG

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.

Caffeine-treated group
AmikacinDRUG

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

Control group

Eligibility Criteria

Age32 Weeks - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All preterm infants with respiratory distress syndrome.

You may not qualify if:

  • Preterm admitted to NICU for other reasons rather than respiratory distress
  • Major congenital anomalies
  • spontaneous intestinal perforation
  • Endocrinal Dysfunctions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU at Alzahraa University Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

caffeine citrateAmikacin

Intervention Hierarchy (Ancestors)

KanamycinAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of pharmacology and toxicology

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 24, 2023

Study Start

October 19, 2023

Primary Completion

April 1, 2024

Study Completion

July 30, 2024

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

EG(1)