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

Overview

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 Title of Study: “Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2023

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • Low-dose group
    • Infants receiving low dose caffeine citrate (up to 10mg/kg/day)
  • High dose group
    • Infants receiving high dose caffeine citrate (exceeding 10mg/kg/day)

Clinical Trial Outcome Measures

Primary Measures

  • EDI change after caffeine citrate loading dose
    • Time Frame: 20 minutes before ~ 20 minutes after loading dose of caffeine citrate
    • changes in EDI min and EDI peak values (μV) after the loading dose administration
  • EDI change after caffeine citrate maintenance dose
    • Time Frame: 20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate
    • changes in EDI min and EDI peak values (μV) after the 1st maintenance dose
  • EDI change after caffeine citrate cessation
    • 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)
    • changes in EDI min and EDI peak values (μV) after caffeine discontinuation

Secondary Measures

  • short-term effect of caffeine citrate administration
    • Time Frame: 24 hours before ~ 24 hours after caffeine citrate administration
    • number of apnea and/or bradycardia

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul St. Mary’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sook Kyung Yum, Professor – The Catholic University of Korea
  • Overall Official(s)
    • Sook Kyung Yum, MD, PhD, Principal Investigator, The Catholic University of Korea
  • Overall Contact(s)
    • Sook Kyung Yum, MD, PhD, +82-2-2258-6993, cookieyyum@gmail.com

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