Clinical trial • Phase IV • Respiratory

CAFFEINE CITRATE for Extubation failure | Bronchopulmonary dysplasia

Phase IV trial of CAFFEINE CITRATE for Extubation failure | Bronchopulmonary dysplasia.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Extubation failure | Bronchopulmonary dysplasia
Trial Stage
Phase IV
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
10-01-2025
First CTIS Authorization Date
15-01-2025

Trial design

Randomised, open-label, intervention: additional loading dose of caffeine citrate one hour before extubation. control: routine dosage of caffeine citrate. Phase IV trial across 8 sites in Hungary.

Randomised
Yes
Open Label
Yes
Comparator
Intervention: Additional loading dose of caffeine citrate one hour before extubation. Control: Routine dosage of caffeine citrate.
Target Sample Size
226

Eligibility

Recruits 226 paediatric patients.

Vulnerable Population
Vulnerable population: preterm neonates. "Lack of consent" is listed as an exclusion criterion. Subject information and informed consent form documents are listed (L1_SIS_and_ICF_minor_HU_2024-519041-29-00, L1_SIS_and_ICF_minor2_HU_2024-519041-29-00).

Inclusion criteria

  • {"criterion_text":"- Preterm neonates born before the 32nd week of gestation and had been mechanicaly ventillated for at least 48 hours. Before the first planned extubation."}

Exclusion criteria

  • {"criterion_text":"- Lack of consent.\n- Preterm neonate with major congenital anomaly.\n- Did not recieved surfactant therapy.\n- Hydrops foetalis.\n- Persistent tachycardia prior to extubation, foetal/neonatal arrhytmia.\n- Asphyxia."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reintubation.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Frequency of apnoeas.\n- Side effects (elevated heart rate, elevated blood pressure, gastric residuals)\n- Necrotizing enterocolitis.\n- Bronchopulmonary dysplasia.\n- The progression or development of intraventricular hemorrhage or periventricular leukomalacia.\n- Neurodevelopmental outcome.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
226
Recruitment Window Months
39
Consent Approach
Informed consent is required; lack of consent is listed as an exclusion criterion. Subject information and informed consent form documents for minors are listed (file names include Hungarian: L1_SIS_and_ICF_minor_HU_2024-519041-29-00 and L1_SIS_and_ICF_minor2_HU_2024-519041-29-00).

Geography

Total Number Of Sites
8
Total Number Of Participants
226

Hungary

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
481
Number Of Sites
8
Number Of Participants
226

Sites

Site Name
Semmelweis University
Department Name
NICU
Contact Person Name
Ákos Gasparics
Contact Person Email
gasparics.akos@semmelweis.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
PIC, Central Hospital of Northern Pest
Contact Person Name
Kinga André
Site Name
University Of Szeged
Department Name
University of Szeged, Pediatrics Department
Contact Person Name
Judit Kiss
Site Name
University Of Debrecen
Department Name
Division of Neonatology, Department of Pediatrics, Clinical Center, University of Debrecen
Contact Person Name
Gergely Balázs
Contact Person Email
balazs.gergely@med.unideb.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Pediatric Specialty Group, Petz Aladár County Teaching Hospital
Contact Person Name
Márta Kovács
Contact Person Email
kovacsm1011@gmail.com
Site Name
Semmelweis University
Department Name
Pediatric Center, Semmelweis University
Contact Person Name
Leina Mahdi
Contact Person Email
leina.mahdi@semmelweis.hu
Site Name
Semmelweis University
Department Name
Department of Obstetrics and Gynaecology, Semmelweis University
Contact Person Name
Fanni Pekli-Tóth
Contact Person Email
pekli.toth.fanni@semmelweis.hu
Site Name
Eszak-Budai Szent Janos Centrumkorhaz
Department Name
PICU, Saint John's Cnetral Hospital Busapest
Contact Person Name
Hicham Dalloul
Contact Person Email
pic@janoskorhaz.hu

Sponsor

Primary sponsor

Full Name
Semmelweis University
Organisation Type
Educational Institution
Country Of Registered Address
Hungary

Investigational products

Investigational Product Name
CAFFEINE CITRATE
Active Substance
CAFFEINE CITRATE
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION, IV INFUSION
Authorisation Status
prodAuthStatus: 2; marketingAuthNumber: -
Maximum Dose
40 mg/kg (max daily dose amount 40)

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