Overview
Sponsor-declared trial summary
Premature infants with Respiratory Distress Syndrome (RDS)
Compare the efficacy of two administration schemes of exogenous pulmonary surfactant in preterm newborns with Respiratory Distress Syndrome (one indicated based on lung ultrasound criteria versus the other following current guideline recommendations) in terms of reducing the number of intubations in the first 72 hours …
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 26 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-26
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515641-42-00
- EudraCT number
- 2022-003106-72
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Compare the efficacy of two administration schemes of exogenous pulmonary surfactant in preterm newborns with Respiratory Distress Syndrome (one indicated based on lung ultrasound criteria versus the other following current guideline recommendations) in terms of reducing the number of intubations in the first 72 hours of life.
Conditions and MedDRA coding
Premature infants with Respiratory Distress Syndrome (RDS)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Premature newborns of both sexes, between 24 and 32 weeks and/or ≤ 1500 grams at birth, who do not meet any of the exclusion criteria, will be included.
Exclusion criteria 6
- Lack of parental informed consent.
- Patients presenting with any of the following conditions: • Chromosomal abnormalities or complex congenital malformations.
- Patients presenting with any of the following conditions: Congenital lung diseases.
- Patients presenting with any of the following conditions: Severe sepsis or septic shock.
- Patients presenting with any of the following conditions: Meconium aspiration syndrome.
- Patients presenting with any of the following conditions: Administration of surfactant in the delivery room.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Intubation rate in the next 72 hours of life.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Curosurf, 240 mg/3 ml, suspensão para instilação endotraqueobrônquica
PRD11035751 · Product
- Active substance
- Phospholipid Fraction, Porcine Lung
- Substance synonyms
- PHOSPHOLIPID FRACTION FROM PIG LUNG
- Pharmaceutical form
- ENDOTRACHEOPULMONARY INSTILLATION, SUSPENSION
- Route of administration
- ENDOTRACHEOPULMONARY USE
- Max daily dose
- 300 mg/kg milligram(s)/kilogram
- Max total dose
- 300 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R07AA02 — NATURAL PHOSPHOLIPIDS
- Marketing authorisation
- 2139988
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2024-06-26 | 2024-06-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo 2022-003106-72_for publication | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF parents | 2 |
| Synopsis of the protocol (for publication) | D1_Protocolo synopsis_NL 2022-003106-72_for publication | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | Spain | Acceptable 2024-06-26
|
2024-06-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-16 | Spain | Acceptable 2024-06-26
|
2025-10-16 |