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

NCT ID: NCT05393817

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2023-10-18

Brief Summary

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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

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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.

Conditions

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Preterm Apnea of Prematurity Caffeine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Low-dose group

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

caffeine citrate

Intervention Type DRUG

caffeine citrate administration, dosage decided by the the physician on duty, within the range of routine management (5mg/kg/day \~ 20mg/kg/day)

High dose group

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

caffeine citrate

Intervention Type DRUG

caffeine citrate administration, dosage decided by the the physician on duty, within the range of routine management (5mg/kg/day \~ 20mg/kg/day)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sook Kyung Yum

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sook Kyung Yum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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Seoul St. Mary's Hospital

Seoul, Seocho-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KC22OISI0314

Identifier Type: -

Identifier Source: org_study_id