Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
226
Countries
1
Sites
8
Extubation failure and bronchopulmonary dysplasia
Our objective was to investigate wether an additional pre extubational loading dose of caffeine-citrate change the extubation success rate.
Key facts
- Sponsor
- Semmelweis University
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 15 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Semmelweis University
External identifiers
- EU CT number
- 2024-519041-29-02
- EudraCT number
- 2022-003202-77
- ClinicalTrials.gov
- NCT06401083
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Our objective was to investigate wether an additional pre extubational loading dose of caffeine-citrate change the extubation success rate.
Secondary objectives 1
- In addition, we want to assess the frequency and severity of side effects. Our objectives include investigating the effect of caffeine-citrate on the development of BPD and IVH and PVL, as well as on the progression of IVH.
Conditions and MedDRA coding
Extubation failure and bronchopulmonary dysplasia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10084219 | Very preterm (28 to 32 weeks) | 100000004848 |
| 20.0 | LLT | 10077328 | Infantile central apnea | 10038738 |
| 20.0 | LLT | 10076729 | Very preterm infant | 10036585 |
| 21.1 | PT | 10028975 | Neonatal respiratory failure | 100000004855 |
| 23.1 | LLT | 10084217 | Extremely preterm (less than 28 weeks) | 100000004848 |
| 20.0 | LLT | 10002973 | Apnea neonatal | 10038738 |
| 20.0 | LLT | 10077325 | Infantile obstructive apnea | 10038738 |
| 20.0 | LLT | 10077322 | Infantile apnea | 10038738 |
| 21.1 | PT | 10006475 | Bronchopulmonary dysplasia | 100000004855 |
| 21.1 | LLT | 10071132 | Primary apnea of premature newborns | 10038738 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | The effect of additional pre-extubational loading dose of caffeine-citrate Randomised controlled trial
|
Randomised Controlled | None | Intervention: Additional loading dose of caffeine citrate one hour before extubation. Control: Routine dosage of caffeine citrate. |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- N/A
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519041-29-00 | The effect of additional pre-extubational loading dose of caffeine-citrate | Semmelweis University |
| 2024-519041-29-01 | The effect of additional pre-extubational loading dose of caffeine-citrate | Semmelweis University |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- Lack of consent. Preterm neonate with major congenital anomaly. Did not recieved surfactant therapy. Hydrops foetalis. Persistent tachycardia prior to extubation, foetal/neonatal arrhytmia. Asphyxia.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reintubation.
Secondary endpoints 1
- Frequency of apnoeas. Side effects (elevated heart rate, elevated blood pressure, gastric residuals) Necrotizing enterocolitis. Bronchopulmonary dysplasia. The progression or development of intraventricular hemorrhage or periventricular leukomalacia. Neurodevelopmental outcome.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB13151MIG · Substance
- Active substance
- Caffeine Citrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 40 mg/kg milligram(s)/kilogram
- Max total dose
- 40 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Semmelweis University
- Sponsor organisation
- Semmelweis University
- Address
- Ulloi Ut 26
- City
- Budapest VIII
- Postcode
- 1085
- Country
- Hungary
Scientific contact point
- Organisation
- Semmelweis University
- Contact name
- Ákos Gasparics MD, PhD
Public contact point
- Organisation
- Semmelweis University
- Contact name
- Ákos Gasparics MD, PhD
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 226 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
University Of Szeged
University of Szeged, Pediatrics Department, Koranyi Fasor 14-15, 6720, Szeged
University Of Debrecen
Division of Neonatology, Department of Pediatrics, Clinical Center, University of Debrecen, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
Department of Obstetrics and Gynaecology, Semmelweis University, Ulloi Ut 78/a, 1082, Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pediatric Specialty Group, Petz Aladár County Teaching Hospital, Vasvari Pal Utca 2-4, 9024, Gyor
Semmelweis University
Pediatric Center, Semmelweis University, Bokay Janos Utca 53, 1083, Budapest VIII
Central Hospital Of Northern Pest Military Hospital
PIC, Central Hospital of Northern Pest, Podmaniczky Utca 109, 1062, Budapest VI
Eszak-Budai Szent Janos Centrumkorhaz
PICU, Saint John's Cnetral Hospital Busapest, Dios Arok 1-3, 1125, Budapest XII
Semmelweis University
NICU, Baross Utca 27, 1082, Budapest VIII
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2025-01-15 | 2025-01-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_HU_2024-519041-29-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements_ENG_2024-519041-29-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_minor_HU_2024-519041-29-00 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_minor2_HU_2024-519041-29-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_CITRATE DE CAFEINE COOPER | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_ENG_2024-519041-29-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_HU_2024-519041-29-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Hungary | Acceptable 2025-01-15
|
2025-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-02 | Hungary | Acceptable | 2026-05-06 |