An observational study in Preterm, Apnea of Prematurity and Caffeine, sponsored by Seoul St. Mary's Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Seoul St. Mary's Hospital · Observational
Caffeine citrate, the first-line agent for apnea of prematurity, enhances diaphragmatic activity. EDI values of neurally adjusted ventilatory assist (NAVA) modes can be used to quantify the diaphragmatic activity triggered by electrical impulse from the respiratory center. This study aims to evaluate the EDI changes following caffeine citrate administration and cessation in preterm infants, and whether such changes are affected by different doses used variably in clinical settings.
Caffeine citrate has been used as the first-line agent for apnea of prematurity. It works via mechanisms including stimulation of the respiratory center in medulla, increasing sensitivity to carbon dioxide retention, and increment in diaphragmatic activity. The effect of caffeine citrate has been evaluated largely based on parameters concerning clinical symptoms (e.g., decrease in the number of apnea, extubation success, decreased incidence of bronchopulmonary dysplasia) but not quantified parameters of actual diaphragmatic activity. Also, while usual doses of caffeine administration is described in the literature, consensus on the effect of caffeine citrate depending on different dosages has not been established.
The current study aims to evaluate effect of caffeine citrate by quantifying the electrical impulses of diaphragmatic activity using EDI values captured from neurally adjusted ventilatory assist (NAVA) mode.
Out of preterm infants necessitating invasive or non-invasive ventilators, those who are supported by invasive or non-invasive NAVA would be recruited. EDI changes would be monitored for the following timepoints: at the administration of caffeine citrate loading dose, 1st maintenance dose after loading, and at cessation of caffeine citrate.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 14 is below the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Seoul St. Mary's Hospital is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm infants admitted to the neonatal intensive care unit of the study site
Exclusion Criteria:
Infants receiving low dose caffeine citrate (up to 10mg/kg/day)
Drug: caffeine citrate
Infants receiving high dose caffeine citrate (exceeding 10mg/kg/day)
Drug: caffeine citrate
caffeine citrate administration, dosage decided by the the physician on duty, within the range of routine management (5mg/kg/day \~ 20mg/kg/day)
Also known as: caffeine, Neocaf injection [20mg] (Pharmbio Korea Inc.), Neocaf solution [20mg] (Pharmbio Korea Inc.)
EDI change after caffeine citrate loading dose
changes in EDI min and EDI peak values (μV) after the loading dose administration
Time frame: 20 minutes before ~ 20 minutes after loading dose of caffeine citrate
EDI change after caffeine citrate maintenance dose
changes in EDI min and EDI peak values (μV) after the 1st maintenance dose
Time frame: 20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate
EDI change after caffeine citrate cessation
changes in EDI min and EDI peak values (μV) after caffeine discontinuation
Time frame: 20 minutes before ~ 48 hours after caffeine citrate discontinuation (discontinuation time point definition: 48~96 hours after the last dose of caffeine citrate administration)
short-term effect of caffeine citrate administration
number of apnea and/or bradycardia
Time frame: 24 hours before ~ 24 hours after caffeine citrate administration
respiratory outcome of caffeine citrate administration (1)
duration of invasive mechanical ventilation (days)
Time frame: During neonatal intensive care unit stay up to 48 weeks postmenstrual age (average of 3 months)
respiratory outcome of caffeine citrate administration (2)
bronchopulmonary dysplasia severity (no/mild/moderate/severe)
Time frame: 36 weeks postmenstrual age or at discharge, whichever comes first
Plan to share: No
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Seoul St. Mary's Hospital