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Completed

NCT Number: NCT05393817

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

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.

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Key information

Conditions

Preterm Apnea Apnea of Prematurity Caffeine Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine citrate

Drug

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. short-term effect of caffeine citrate administration

    Time frame: 24 hours before ~ 24 hours after caffeine citrate administration

    number of apnea and/or bradycardia

Other outcomes

  1. respiratory outcome of caffeine citrate administration (1)

    Time frame: During neonatal intensive care unit stay up to 48 weeks postmenstrual age (average of 3 months)

    duration of invasive mechanical ventilation (days)

  2. respiratory outcome of caffeine citrate administration (2)

    Time frame: 36 weeks postmenstrual age or at discharge, whichever comes first

    bronchopulmonary dysplasia severity (no/mild/moderate/severe)

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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