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

Recruiting now · Phase 4

Conditions studied: Apnea of Prematurity, Premature Birth, Respiratory Failure

In brief

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.

Key facts

Study ID

NCT06401083

Run by

Semmelweis University

People needed

226

Starts

2023-12-21

Expected to finish

2028-12-01

Last updated by the study team

2024-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Premature infant born before 32nd week of gestation is completed;
• Had been mechanically ventilated for at least 48 hours;
• Before the first planned extubation.

You may not qualify if…

• 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.

Where it is running

• Pediatric Center, Semmelweis University — Budapest, Hungary (enrolling)
• Department of Obstetrics and Gynecology, Semmelweis University — Budapest, Hungary (enrolling)

Full record on ClinicalTrials.gov

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