NCT05393817

Brief 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. 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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

May 20, 2022

Last Update Submit

November 26, 2023

Conditions

PretermApnea of PrematurityCaffeine

Outcome Measures

Primary Outcomes (3)

  • 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)

Secondary Outcomes (1)

  • short-term effect of caffeine citrate administration

    24 hours before ~ 24 hours after caffeine citrate administration

Other Outcomes (2)

  • respiratory outcome of caffeine citrate administration (1)

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

  • respiratory outcome of caffeine citrate administration (2)

    36 weeks postmenstrual age or at discharge, whichever comes first

Study Arms (2)

Low-dose group

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

Drug: caffeine citrate

High dose group

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

Drug: caffeine citrate

Interventions

caffeine citrateDRUG

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

Also known as: caffeine, Neocaf injection [20mg] (Pharmbio Korea Inc.), Neocaf solution [20mg] (Pharmbio Korea Inc.)
High dose groupLow-dose group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants admitted to the neonatal intensive care unit of the study site

You may qualify if:

  • Preterm infants born at less than 34 weeks' gestation who are supported by invasive or non-invasive NAVA

You may not qualify if:

  • major congenital anomaly, chromosomal or genetic abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

Location

MeSH Terms

Conditions

Premature BirthApnea

Interventions

caffeine citrateCaffeine

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sook Kyung Yum, MD, PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 26, 2022

Study Start

June 8, 2022

Primary Completion

October 18, 2023

Study Completion

October 18, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)