Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes

Seoul St. Mary's Hospital

Status: Completed

Conditions: Caffeine; Preterm; Apnea of Prematurity

Treatments: Drug: caffeine citrate

Study type: Observational

Funder types: Other

Identifiers

NCT05393817

KC22OISI0314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 2 patient groups

Low-dose group

Description:

Infants receiving low dose caffeine citrate (up to 10mg/kg/day)

Treatment:

Drug: caffeine citrate

High dose group

Description:

Infants receiving high dose caffeine citrate (exceeding 10mg/kg/day)

Treatment:

Drug: caffeine citrate