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

Caffeine Clinical Trial

Official title:

Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393817
• Other study ID #: KC22OISI0314
• Status: Completed
• Start date: June 8, 2022
• Est. completion date: October 18, 2023

Study information

• Verified date: November 2023
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Prematurity
• Caffeine
• Premature Birth
• Preterm

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Seocho-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	respiratory outcome of caffeine citrate administration (1)	duration of invasive mechanical ventilation (days)	During neonatal intensive care unit stay up to 48 weeks postmenstrual age (average of 3 months)
Other	respiratory outcome of caffeine citrate administration (2)	bronchopulmonary dysplasia severity (no/mild/moderate/severe)	36 weeks postmenstrual age or at discharge, whichever comes first
Primary	EDI change after caffeine citrate loading dose	changes in EDI min and EDI peak values (µV) after the loading dose administration	20 minutes before ~ 20 minutes after loading dose of caffeine citrate
Primary	EDI change after caffeine citrate maintenance dose	changes in EDI min and EDI peak values (µV) after the 1st maintenance dose	20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate
Primary	EDI change after caffeine citrate cessation	changes in EDI min and EDI peak values (µV) after caffeine discontinuation	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	short-term effect of caffeine citrate administration	number of apnea and/or bradycardia	24 hours before ~ 24 hours after caffeine citrate administration