Clinical trial

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

Name

KC22OISI0314

Description

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.

Trial arms

Trial start

2022-06-08

Estimated PCD

2023-10-18

Trial end

2023-10-18

Status

Completed

Treatment

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:

High dose group, Low-dose group

Other names:

caffeine, Neocaf injection [20mg] (Pharmbio Korea Inc.), Neocaf solution [20mg] (Pharmbio Korea Inc.)

Size

Primary endpoint

EDI change after caffeine citrate loading dose

20 minutes before ~ 20 minutes after loading dose of caffeine citrate

EDI change after caffeine citrate maintenance dose

20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate

EDI change after caffeine citrate cessation

20 minutes before ~ 48 hours after caffeine citrate discontinuation (discontinuation time point definition: 48~96 hours after the last dose of caffeine citrate administration)

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

1 product

3 indications

Organization

Seoul St. Mary's Hospital

Product

Indication

Indication

Indication