PretermNCT05393817
Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes
An observational study of Preterm and Apnea of Prematurity, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm, Apnea of Prematurity, Caffeine
- What is being tested?
- caffeine citrate
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2022to 18 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants admitted to the neonatal intensive care unit of the study site
Who may be able to join
- Preterm infants born at less than 34 weeks' gestation who are supported by invasive or non-invasive NAVA
Who cannot join
- major congenital anomaly, chromosomal or genetic abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation
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.
Read the detailed 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.
- Conditions
- Preterm, Apnea of Prematurity, Caffeine
- Being tested
- caffeine citrate
- Medical subject headings
- Premature Birth, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine citrateDrug
Also called caffeine, Neocaf injection [20mg] (Pharmbio Korea Inc.), Neocaf solution [20mg] (Pharmbio Korea Inc.)
caffeine citrate administration, dosage decided by the the physician on duty, within the range of routine management (5mg/kg/day ~ 20mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Infants receiving low dose caffeine citrate (up to 10mg/kg/day) Receives: Drug: caffeine citrate | |
| High dose group | Infants receiving high dose caffeine citrate (exceeding 10mg/kg/day) Receives: Drug: caffeine citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDI change after caffeine citrate loading dose
changes in EDI min and EDI peak values (μV) after the loading dose administration
Measured: 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
Measured: 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
Measured: 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 outcomes (1)
short-term effect of caffeine citrate administration
number of apnea and/or bradycardia
Measured: 24 hours before ~ 24 hours after caffeine citrate administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start8 Jun 2022
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sook Kyung Yum, The Catholic University of Korea
- Investigators
- Sook Kyung Yum, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393817
- Sponsor's protocol ID
- KC22OISI0314
- Status last verified
- Nov 2023
- First submitted
- 20 May 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation
- ClinicalTrials.gov ID
- NCT05393817
- Acronym / sponsor ID
- KC22OISI0314
- Conditions
- Preterm, Apnea of Prematurity, Caffeine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | – | Drug: caffeine citrateInfants receiving low dose caffeine citrate (up to 10mg/kg/day) |
| High dose group | – | Drug: caffeine citrateInfants receiving high dose caffeine citrate (exceeding 10mg/kg/day) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants admitted to the neonatal intensive care unit of the study site
Key inclusion criteria (1 listed)
- Preterm infants born at less than 34 weeks' gestation who are supported by invasive or non-invasive NAVA
Key exclusion criteria (1 listed)
- major congenital anomaly, chromosomal or genetic abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeine citrateAlso: caffeine, Neocaf injection [20mg] (Pharmbio Korea Inc.), Neocaf solution [20mg] (Pharmbio Korea Inc.)caffeine citrate administration, dosage decided by the the physician on duty, within the range of routine management (5mg/kg/day ~ 20mg/kg/day) | Drug | High dose group, Low-dose group |
Primary outcome
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
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
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
1 secondary outcome
short-term effect of caffeine citrate administration
Time frame: 24 hours before ~ 24 hours after caffeine citrate administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sook Kyung Yum, MD, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm and Apnea of Prematurity, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDI change after caffeine citrate loading dose (time frame: 20 minutes before ~ 20 minutes after loading dose of caffeine citrate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.