Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| short-term effect of caffeine citrate administration | number of apnea and/or bradycardia | 24 hours before ~ 24 hours after caffeine citrate administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| respiratory outcome of caffeine citrate administration (2) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Preterm infants admitted to the neonatal intensive care unit of the study site
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sook Kyung Yum, MD, PhD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | Seocho-Gu | 06591 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C026189 | caffeine citrate |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
Not provided
Not provided
Not provided
Not provided
Not provided
|
bronchopulmonary dysplasia severity (no/mild/moderate/severe) |
| 36 weeks postmenstrual age or at discharge, whichever comes first |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |