1. Home
  2. Approved trials
  3. » فارسی

Investigation of the safety and efficacy of Varasurf (ovine pulmonary surfactant, produced by Artiman Pharmed Alborz company) compared to Curosurf (porcine pulmonary surfactant produced by Chiesi company) in premature neonates with gestational ages between 28 and 34 weeks with respiratory distress syndrome (RDS)

Protocol summary

Study aim
Safety and efficacy evaluation of Varasurf compared with Curosurf in neonates with respiratory distress syndrome
Design
A double-arm, double-blind, active-controlled, randomized phase I/III clinical trial in preterm neonates
Settings and conduct
In the Phase I, after obtaining informed consent from parents or legal guardians and if the neonates were eligible to enroll the study, 5 or 15 premature neonates (based on the DSMB will receive Varasurf. 7 days after the enrollment of the last neonate, the study report will be presented to DSMB members. In case of DSMB committee approval, the phase III study will be initiated randomized, double-blind, double-arm, parallel, active control, non-inferiority in terms of safety and efficacy compared to Curosurf. In the Phase III , if informed consent is obtained, infants who were admitted due to RDS in the NICU of Akbarabadi Hospitals in Tehran, Omolbanin Hospital in Mashhad, and Aliebneabitaleb Hospital in Zahedan, if they are eligible to study enrollment, they will receive a random code. In Phase III, 104 premature neonates (52 neonates in each arm) will receive Varasurf or Curosurf surfactant in a random ratio (1:1).
Participants/Inclusion and exclusion criteria
Premature neonates with RDS with a gestational age of 28 to 34 weeks and a weight of 1000 to 2500 kg born in the study hospital and have an indication for receiving surfactant who do not have any other diseases.
Intervention groups
The intervention group received Varasurf and the control group received Curosurf intratracheally (through a endotracheal tube).
Main outcome variables
The efficacy outcomes including changes in MAP, SpO2, FIO2, and the duration of mechanical ventilation. Safety outcomes including adverse events, death, pulmonary hemorrhage, sepsis, pneumothorax, IVH and BPD

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180515039672N4
Registration date: 2024-05-25, 1403/03/05
Registration timing: prospective

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Maryam Amini Pouya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
maryam.aminipooya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-05, 1403/03/16
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the safety and efficacy of Varasurf (ovine pulmonary surfactant, produced by Artiman Pharmed Alborz company) compared to Curosurf (porcine pulmonary surfactant produced by Chiesi company) in premature neonates with gestational ages between 28 and 34 weeks with respiratory distress syndrome (RDS)
Public title
Clinical trial of Varasurf compared with Curosurf
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature neonate with respiratory distress syndrome based on physician's diagnosis Born with gestational age of 28 to 34 weeks in the location of study site With birth weight between 1000 and 2500 grams Study enrollment and receiving the first dose of surfactant up to 6 hours after birth The need for fraction of inspired oxygen (FIO2) more than 30% to maintain saturation of peripheral oxygen (SPO2) 90-94% Failure of early nasal continuous positive airway pressure (CPAP) immediately after birth Signing the informed consent form by the parent or legal guardian of the neonate
Exclusion criteria:
Moderate to severe asphyxia at birth (Apgar Score 5- and 10-minute, less than 5 or the need for continuous resuscitation 10 minutes after the birth of the neonate, or umbilical cord arterial blood gas (ABG) result with pH less than 7) Neonatal encephalopathy Receiving any type of surfactant by neonates before the study enrollment Diagnosis of major congenital anomalies (congenital cardiac anomalies, life-threatening anomalies, respiratory failure due to causes other than RDS, and chromosomal abnormalities) Presence of pulmonary hemorrhage and pneumothorax before the study enrollment Simultaneous participation of the neonate in other clinical trials The neonate's need for surgical procedures The need for invasive mechanical ventilation of the neonates before study enrollment or before administration of surfactant (phase I only) Neonatal hypoglycemia (plasma glucose concentration lower than 50 mg/dl with a glucometer) History of mother's addiction to alcohol or drugs Diagnosis of maternal chorioamnionitis History of neonatal convulsions Presence of meconium aspiration in neonate Rupture of membrane more than 18 hours
Age
From 1 day old to 1 day old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 119
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization in phase III is done using block randomization, and stratified based on site, gestational age (GA) and the presence or absence of endotracheal tube in the screening visit. The construction of the random sequence of neonates is done by the website sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
A trained unblinded nurse draws the surfactant into the syringe based on the random codes and delivers it to the physician. The physician administrates the prepared coded syringe to the neonate and is blinded regarding the type of prescribed surfactant. The neonate's parents will not be informed about the type of surfactant received. Also, according to the identity codes of each neonate that is created at the beginning of the study, the study data will be presented blindly to the data analyst team.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of National Research Ethics Committee
Street address
13th floor, Block A, Ministry of health, Simaye Iran street, Shahrake Ghods(Gharb)
City
Tehran
Province
Tehran
Postal code
1417993337
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.NREC.1403.001

Health conditions studied

1

Description of health condition studied
Respiratory Distress Syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
The area under the curve of the need for fraction of inspired oxygen
Timepoint
Immediately before the administration of surfactant until 6 hours (0, 0.25, 0.5, 1, 2, 3, 4, 5 and 6 hours) after the administration of the first surfactant
Method of measurement
Fraction of inspired oxygen recording

2

Description
Duration of respiratory support need (invasive and non-invasive mechanical ventilation)
Timepoint
Up to 28 days after receiving the first dose of surfactant
Method of measurement
Day

Secondary outcomes

1

Description
Changes in need to fraction of inspired oxygen
Timepoint
Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant
Method of measurement
fraction of inspired oxygen recording

2

Description
Need for continued the invasive mechanical ventilation
Timepoint
Up to 72 hours after surfactant administration
Method of measurement
Neonates rate

3

Description
The saturation of peripheral oxygen percentage (SpO2)
Timepoint
Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant
Method of measurement
Pulse oximetry

4

Description
Mean Airway Pressure
Timepoint
Immediately before surfactant injection and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 12, 18, 24, 36, 48 and 72 hours and 4, 5, 6 and 7 days after administration of the first dose of surfactant
Method of measurement
respiratory ventilation system recording

5

Description
Duration of hospitalization
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
Day

6

Description
Frequency of surfactant administration
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
Recording the frequency of administration

7

Description
patent ductus arteriosus (PDA) occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage

8

Description
Pneumothorax occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage (diagnosis based on chest-X Ray)

9

Description
Sepsis occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage (diagnosis by positive blood culture in neonates with suspected clinical symptoms)

10

Description
Intra ventricular hemorrhage (IVH) occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage

11

Description
Pulmonary hemorrhage occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage (diagnosis based on chest-X Ray)

12

Description
Death occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage

13

Description
Bronchopulmonary Dysplasia (BPD) occurrence
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
number/percentage of neonates' who need to supplemental oxygen

14

Description
occurrence of any other adverse events
Timepoint
Up to 28 days after birth or 36 weeks post mensural age
Method of measurement
Physical examination and paraclinical results

Intervention groups

1

Description
Intervention group: A 3 ml vial of Varasurf with a concentration of 80mg/ml (pulmonary surfactant manufactured by Artiman Pharmed Alborz), which is administered intratracheally (through a endotracheal tube). 2.5ml/kg of neonate's body weight for the first dose, up to two additional doses of 1.25ml/kg of neonate's body weight (max dose: 5ml/kg of neonate's body weight).
Category
Treatment - Drugs

2

Description
Control group: A 3 ml vial of Curosurf with a concentration of 80mg/ml (pulmonary surfactant manufactured by Chiesi), which is administered intratracheally (through a endotracheal tube). 2.5ml/kg of neonate's body weight for the first dose, up to two additional doses of 1.25ml/kg of neonate's body weight (max dose: 5ml/kg of neonate's body weight).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Mandana Kashaki
Street address
Bagh Ferdows Station, Molavi Street,
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
Email
kashakimd@gmail.com

2

Recruitment center
Name of recruitment center
Omolbanin Hospital
Full name of responsible person
Mohammad Heidarzadeh
Street address
Next to 16th Ave., Ayatollah Bahjat St., Zarrineh intersection,
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734767
Phone
+98 51 3223 1061
Fax
Email
heidarzadeh_2013@yahoo.com

3

Recruitment center
Name of recruitment center
Aliebne Abitaleb Hospital
Full name of responsible person
Mohammad Heidarzadeh
Street address
Salamat BLVD., Khalij Fars Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 1341 1260
Fax
Email
heidarzadeh_2013@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artiman Pharmed Alborz
Full name of responsible person
Yeganeh Talebkhan Garoosi
Street address
Unit 104, First floor, Biotechnology Building, South Pazhouhesh BLVD., Shahid Hamedani highway
City
Tehran
Province
Tehran
Postal code
1497719808
Phone
+98 21 4936 1350
Fax
Email
y.talebkhan@artimanpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artiman Pharmed Alborz
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tiva Pharmed Salamat
Full name of responsible person
Fatemeh Sadat Emami
Position
Clinical Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, Unit 56, 1st Bahar Ave., Riazi Bakhshayesh St., Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998888178
Phone
+98 21 2235 9961
Email
f.emami@tivapharmed.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad Heidarzadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatology
Street address
Ali ebn Abi Taleb Hospital, Salamat BLVD., Khalij Fars Highway,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 1341 1260
Fax
Email
heidarzadeh_2013@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tiva Pharmed Salamat
Full name of responsible person
Fatemeh Sadat Emami
Position
Clinical Research Associate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, Unit 56, 1st Bahar Ave., Riazi Bakhshayesh St., Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998888178
Phone
+98 21 2235 9961
Email
f.emami@tivapharmed.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...