Clinical trial NCT05393817: Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes
Official title: Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm
Apnea of Prematurity
Caffeine
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants admitted to the neonatal intensive care unit of the study site

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants born at less than 34 weeks' gestation who are supported by invasive or non-invasive NAVA

Exclusion Criteria:

* major congenital anomaly, chromosomal or genetic abnormality

Primary outcomes:
measure: EDI change after caffeine citrate loading dose
timeFrame: 20 minutes before ~ 20 minutes after loading dose of caffeine citrate
measure: EDI change after caffeine citrate maintenance dose
timeFrame: 20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate
measure: EDI change after caffeine citrate cessation
timeFrame: 20 minutes before ~ 48 hours after caffeine citrate discontinuation (discontinuation time point definition: 48~96 hours after the last dose of caffeine citrate administration)
Secondary outcomes:
measure: short-term effect of caffeine citrate administration
timeFrame: 24 hours before ~ 24 hours after caffeine citrate administration
Other outcomes:
measure: respiratory outcome of caffeine citrate administration (1)
timeFrame: During neonatal intensive care unit stay up to 48 weeks postmenstrual age (average of 3 months)
measure: respiratory outcome of caffeine citrate administration (2)
timeFrame: 36 weeks postmenstrual age or at discharge, whichever comes first
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-Gu
Study officials:
affiliation: The Catholic University of Korea
name: Sook Kyung Yum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: