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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Premature infant born before 32nd week of gestation is completed;

• Had been mechanically ventilated for at least 48 hours;

• Before the first planned extubation.

Locations
Other Locations
Hungary
Department of Obstetrics and Gynecology, Semmelweis University
RECRUITING
Budapest
Pediatric Center, Semmelweis University
RECRUITING
Budapest
Contact Information
Primary
Kinga Kovács, MD.
kovacs.kinga1@semmelweis.hu
+36206663718
Backup
Ákos Gasparics, MD.PhD
gasparics.akos@semmelweis.hu
+36206663684
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2028-12
Participants
Target number of participants: 226
Treatments
Active_comparator: Pre-extubational caffeine-citrate
Participants will receive 20 mg/kg loading dose of caffeine citrate on the first day of life and after that 5-10 mg/kg maintenance dose each day. On this arm, the participants will receive 20 mg/kg caffeine dose once again before the planned extubation.
No_intervention: Routine care
Participants will receive 20 mg/kg loading dose of caffeine citrate on the first day of life and after that 5-10 mg/kg maintenance dose each day, also on the day of the extubation.
Sponsors
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov