MedTrace Logo

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

NCT06401083 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2024-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg/kg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations.

According to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg/kg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg/kg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.

Conditions

Interventions

DRUG

Caffeine citrate

20 mg/kg caffeine-citrate before the planned extubation.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Ákos Gasparics, MD.PhD · Semmelweis University, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06401083 on ClinicalTrials.gov