The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSemmelweis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Premature infant born before 32nd week of gestation is completed;
Had been mechanically ventilated for at least 48 hours;
Before the first planned extubation.
Disqualifiers
Lack of informed consent, refusal to participate in the study;
Major congenital anomaly;
Had not received surfactant treatment;
Hydrops foetalis;
Trial design
Design model
Parallel
Treatments tested in this trial
Caffeine citrate
Drug20 mg/kg caffeine-citrate before the planned extubation.
Treatment groups
226 Participants
are divided into 2 treatment groupsGroup A: Pre-extubational caffeine-citrateActive comparator 1 intervention
Group B: Routine careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of extubation failure
Reintubation. The discretion of the attending physician.
Time frame
48 hoursSecondary outcomes
1
Frequency of apneas
Respiratory failure of 15-20 seconds or shorter duration associated with bradycardia or desaturation.
Time frame
48 hours2
Change in the mean heart rate
Mean heart rate measured 24 hours before and 48 hours after intervention.
Time frame
72 hours3
Tachycardia
The time interval when the heart rate \>200 (min) during one day (1440 min) in percentage.
Time frame
72 hours4
Volume of gastric residuals
Gastric residuals measured 24 hours before and 48 hours after intervention.
Time frame
72 hoursSponsors and contacts
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Source ClinicalTrials.gov