Clinical trial • Phase II • Respiratory

PHOSPHOLIPID FRACTION, PORCINE LUNG for Respiratory Distress Syndrome (RDS)

Phase II trial of PHOSPHOLIPID FRACTION, PORCINE LUNG for Respiratory Distress Syndrome (RDS).

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Respiratory Distress Syndrome (RDS)
Trial Stage
Phase II
Drug Modality
Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
21-06-2024
First CTIS Authorization Date
26-06-2024

Trial design

Randomised, two administration schemes of exogenous pulmonary surfactant: one indicated based on lung ultrasound criteria versus the other following current guideline recommendations.-controlled Phase II trial across 1 site in Spain.

Randomised
Yes
Comparator
Two administration schemes of exogenous pulmonary surfactant: one indicated based on lung ultrasound criteria versus the other following current guideline recommendations.
Target Sample Size
30

Eligibility

Recruits 30 paediatric patients.

Vulnerable Population
Premature newborns (neonates) are identified as a vulnerable population. Parental informed consent is required ("Lack of parental informed consent." is listed as an exclusion criterion). No assent process is mentioned.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- Lack of parental informed consent."}
  • {"criterion_text":"- Patients presenting with any of the following conditions: • Chromosomal abnormalities or complex congenital malformations."}
  • {"criterion_text":"- Patients presenting with any of the following conditions: Congenital lung diseases."}
  • {"criterion_text":"- Patients presenting with any of the following conditions: Severe sepsis or septic shock."}
  • {"criterion_text":"- Patients presenting with any of the following conditions: Meconium aspiration syndrome."}
  • {"criterion_text":"- Patients presenting with any of the following conditions: Administration of surfactant in the delivery room."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Intubation rate in the next 72 hours of life.","definition_or_measurement_approach":"Measured as intubation events occurring within the first 72 hours of life (intubation rate within 72 hours)."}

Recruitment

Planned Sample Size
30
Recruitment Window Months
48
Consent Approach
Parental informed consent is required; lack of parental informed consent is an exclusion criterion. A Subject Information and Informed Consent Form for parents is listed among documents (L1_SIS and ICF parents). No assent or additional consent details are provided.

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Spain

Earliest CTIS Part Ii Submission Date
21-06-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
5
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Pediatrics
Principal Investigator Name
Juan José Rafael Salazar Quiroz
Principal Investigator Email
jsalazarq@santpau.cat
Contact Person Name
Juan José Rafael Salazar Quiroz
Contact Person Email
jsalazarq@santpau.cat
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Curosurf, 240 mg/3 ml, suspensão para instilação endotraqueobrônquica
Active Substance
PHOSPHOLIPID FRACTION, PORCINE LUNG
Modality
Other
Routes Of Administration
Endotracheopulmonary instillation
Route
Endotracheopulmonary
Authorisation Status
Authorised in Portugal (marketing authorisation number 2139988)
Maximum Dose
300 mg/kg

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