Efficacy and safety of SURFACEN® administration by tracheal catheterization in preterm neonates with respiratory distress syndrome. Phase II/III

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the efficacy and safety of SURFACEN® administration by tracheal catheterization in preterm neonates with respiratory distress syndrome. Phase II/III

Secondary indentifying numbers:

PNBCF9523-1

Issuing authority of the secondary identifying numbers:

National Center for Animal and Plant Health (CENSA)

Source(s) of monetary or material support:

National Program for Biotechnology, Pharmaceutical Industry and Medical Technology

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Osmany

Last name:

Martinez Lemus

Medical Specialty :

First Degree Specialist in Comprehensive General Medicine, Second Degree Specialist in neonatology

Affiliation:

Ivan Portuondo Teaching General Hospital

Postal address:

Calle 78 # 3310 e/ 33 y 35. San Antonio de los Bannos

City:

Artemisa

País:

Cuba

Zip Code:

32500

Telephone:

+53-49385368

Email address:

osmanyml84@nauta.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Mayabeque, Manuel Piti Fajardo Maternity and Children's Hospital, Mercedes Capote Lobo, MD. First Degree Specialist in Comprehensive General Medicine and in Neonatology

Havana, Eusebio Hernandez Maternity and Children's Hospital, Leonel Mendez Alarcon, MD. First Degree Specialist in Comprehensive General Medicine and Second Degree Specialist in Neonatology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/03/2025

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Respiratory Distress Syndrome (RDS)

Intervention(s):

Minimally Invasive Surfacen Group (Experimental): A 100 mg/kg dose of SURFACEN® will be administered by less-invasive surfactant administration (LISA) in the first 2 hours of life, as to guarantee the early use of the surfactant. If no improvement in the patient's oxygenation status is reached, a second dose of SURFACEN® will be administered at 6 hours after the first dose has been administered. The second dose will be administered by LISA if the patient is still breathing spontaneously and effectively and has no severe respiratory acidosis and RDS; otherwise, it will be administered using an invasive ventilatory support provided by endotracheal tube.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Total Time Mechanical Ventilation (MV) (Time from when the patient begins ventilating until ventilatory support is discontinued, regardless of the ventilatory mode used.). Measurement time: At baseline and, At patient discharge from Neonatal Intensive Care Unit (NICU).

Key secondary outcomes:

1. Need for prolonged ventilation (Yes: when ventilation continues at 7 days, No: when ventilation is withdrawn at day 7). Measurement time: Day 7th. 2. Need for endotracheal intubation (Yes, No). Measurement time: Within 72 hours after treatment administration. 3. Need for Invasive Mechanical Ventilation (Yes, No). Measurement time: Within 72 hours after treatment administration. 4. Complications associated with Mechanical Ventilation (Complications presented: Bronchopulmonary Dysplasia (BPD), Retinopathy of Prematurity (ROP), Pneumothorax, Intraventricular Hemorrhage (IVH), Patent Ductus Arteriosus (PDA), Periventricular Leukomalacia (PVL), or others). Measurement time: At patient discharge from NICU. 5. Fraction of Inspired Oxygen-FiO2 (It will be obtained automatically through the values indicated in the ventilation equipment). Measurement time: At baseline, one hour and four hours after each SURFACEN® administration. 6. Oxygenation and blood gas parameters (PaO2/FiO2 ratio, pulse saturation, pH, PaCO2 obtained through blood gas and saturation measurement). Measurement time: At baseline, one hour and four hours after each SURFACEN® administration. 7. NICU stay (Time elapsed between admission and discharge from ICUs). Measurement time: At discharge from NICU. 8. Survival at NICUs discharge (alive or deceased. If deceased, date and cause will be collected). Measurement time: At discharge of NICU. 9. Survival at 28 days after birth (alive or deceased. If deceased, date and cause will be collected). Measurement time: Day 28th. 10. Adverse Events-AE (Occurrence of AE (Yes, No); Type of AE (description of AE); Severity of AE (Severe/Serious, Not severe/Not serious). In case of Severe/Serious: (It threatens the patient life, it prolongs hospitalization, it results in the patient death, in a significant or persistent disability, and in a birth defects or congenital anomalies); Intensity of AE (Mild, Moderate, Severe); Duration of AE (Time elapsed between start and end of AE); Causality relationship (Highly probable/Certain, Probable, Possible, Unlikely, Unrelated, Not evaluable/Unclassifiable); Treatment of AE (Name of treatment indicated, Dose, Route of administration, Start and end date of treatment); Outcome of AE (Recovered, Improved, Persists, Leaves sequelae or Causes death); Treatment attitude (No changes, Temporary discontinuance, Permanent discontinuance); SURFACEN® lot (lot number of each SURFACEN® bulb used). Measurement time: Up to eight hours after the last SURFACEN® dose.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

1minutes (Newborn)

Maximum age:

Less than 2 hours (Newborn)

Inclusion criteria:

1. Patient less than 2 hours old. 2. Patient born at gestational age between 26 and 36 weeks or both. 3. Patient with effective and spontaneous breathing, ventilated on nasal CPAP (continuous positive airway pressure) by RDS. 4. Patient with early use of SURFACEN®. The early use criteria are a) Patient with gestational age less than 30 weeks, who have not received prenatal lung maturation and have an established RDS of prematurity; or b) Preterm patients regardless of their gestational age, whether or not they have received prenatal lung maturation, who are on nasal CPAP with 6 cm H2O and require a FiO2 ≥ 0.3 to maintain adequate levels of SpO2 (partial oxygen saturation) in the first two hours of life. 5. Patient whose mother and/or father, or legal representative of the mother, expressed written willingness to participate in the study by signing the Informed Consent Form.

Exclusion criteria:

1. Major congenital malformations. 2. Perinatal asphyxia and neuromuscular diseases. 3. Pneumothorax or pneumomediastinum prior to the initiation of SURFACEN® treatment. 4. Pulmonary hemorrhage prior to the initiation of SURFACEN® treatment. 5. Severe respiratory distress syndrome. 6. Fraction of inspired oxygen (FiO2) requirements ≥ 0.5. 7. Severe respiratory acidosis. 8. Patient with hemodynamic instability. 9. Patient with recurrent apneas. 10. Patient who has required endotracheal intubation in delivery room, when arriving at ICUs or prior to SURFACEN® treatment. 11. Patient receiving treatment with another product under research.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

2-3

Target sample size:

148

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yinet

Last Name:

Barrese Perez

Specialty:

Pharmaceutical Sciences Degree. Master in Clinical Pharmacy

Affiliation:

National Coordinating Center for Clinical Trials (CENCEC)

Postal Address:

5ta A e/60 y 62 Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164226, +53-72164225

Email :

yinet@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Osmany

Last Name:

Martinez Lemus

Specialty:

First Degree Specialist in Comprehensive General Medicine, Second Degree Specialist in Neonatology

Affiliation:

Ivan Portuondo Teaching General Hospital

Postal Address:

Calle 78 # 3310 e/ 33 y 35. San Antonio de los Bannos

City:

Artemisa

País:

Cuba

Zip Code:

32500

Telephone:

+53-49385368

Email :

osmanyml84@nauta.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Ivan Portuondo Teaching General Hospital

Manuel Piti Fajardo Maternity and Children's Hospital

Eusebio Hernandez Maternity and Children's Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

05/07/2024

16/07/2024

13/11/2024

Postal address of Ethic Committee :

Calle 78 s/n, entre 33 y 37, San Antonio de los Bannos, Artemisa. Cuba

Avenida 77 No. 7610 entre 76 y 78, Guines, Mayabeque. Cuba

Ave 31 No.8409 e/ 84 y 100, Marianao, La Habana. Cuba

Telephone:

+53-49389397

+53-47522724

+53-53888132

Correo electrónico:

osmanymtnez@infomed.sld.cu

ghdez@infomed.sld.cu

elaineb@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

21/07/2027

Date of available results:

17/01/2028

Date of first publication:

16/05/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000452

Date of Registration in Primary Registry:

12/12/2024

Record Verification Date:

2024/12/12

Next update date:

2025/12/12

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Efficacy and safety of SURFACEN® administration by tracheal catheterization in preterm neonates with respiratory distress syndrome. Phase II/III

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