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

Launched by SEMMELWEIS UNIVERSITY · May 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether giving a single extra dose of caffeine citrate one hour before removing a breathing tube (a process called extubation) can help preterm infants breathe on their own successfully. The study specifically focuses on infants born before the 32nd week of pregnancy who have been on a ventilator for at least 48 hours. Researchers want to see if this additional caffeine dose can reduce breathing pauses (called apneas) and check for any side effects or complications during and after the treatment.

To be eligible for the trial, infants must be preterm, have been mechanically ventilated for the required time, and be scheduled for extubation. Those with major birth defects or certain health issues, like heart problems or lack of consent from parents, cannot participate. Families whose infants join the study can expect to be involved in a well-monitored process, comparing the effects of the extra caffeine dose to standard care. The results will help determine if this approach is beneficial for these vulnerable babies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Premature infant born before 32nd week of gestation is completed;
• • Had been mechanically ventilated for at least 48 hours;
• • Before the first planned extubation.
• Exclusion Criteria:
• • Lack of informed consent, refusal to participate in the study;
• • Major congenital anomaly;
• • Had not received surfactant treatment;
• • Hydrops foetalis;
• • Persistent tachycardia before extubation, fetal/neonatal arrhythmia;
• • Asphyxia.