Respiratory Distress SyndromePhase 2/3NCT02305160
A Multicenter, Randomized, Open Label Trial of a New Animal Extracted Surfactant to Treat RDS in Preterm Infants
A Phase 2/3 study testing Butantan in people with Respiratory Distress Syndrome, run by University of Sao Paulo at 30 sites in Brazil.
Trial summary
The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil. Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Butantan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 30 sitesBrazil
- Study dates
- Apr 2005to Jul 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age below 34 weeks
- RDS diagnosis based on clinical and RDS radiographic patterns
- Need of mechanical ventilation
- Parental consent
Who cannot join
- Age greater than 24 hours
- Major congenital malformations
- Unstable hemodynamic status
- Occurence of seizure during the stay in the Neonatal Intensive Care Unit
- Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Brazil30 sites
Hospital Santa Isabel
Aracaju, Sergipe, 49060-640
Maternidade Hildete Falcao Batista
Aracaju, Sergipe, 49085-310
Maternidade Odete Valadares
Belo Horizonte, Minas Gerais, 30110-130
Santa Casa de Misericórdia de BH
Belo Horizonte, Minas Gerais, 30140-080
Hospital de Clínicas de Minas Gerais
Belo Horizonte, Minas Gerais, 30180-112
Hospital Sofia feldman
Belo Horizonte, Minas Gerais, 30260-020
Hospital Municipal Odilon Behrens
Belo Horizonte, Minas Gerais, 30575-740
Hospital Julia Kubstchek
Belo Horizonte, Minas Gerais, 30620-470
Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, 18601-020
Hospital Regional de Taguatinga
Brasília, Federal District, 70673-423
Hospital Cachoeirinha
Cachoeirinha, Rio Grande do Sul, 94950-585
Universidade de Campinas - UNICAMP
Campinas, São Paulo, 13083-881
Hospital Materno Infantil
Goiânia, Goiás, 74673-200
Hospital Femina
Porto Alegre, Rio Grande do Sul, 91430-001
Grupo Hospital Criança Conceicao
Porto Alegre, Rio Grande do Sul
Hospital Alvorada
Porto Alegre, Rio Grande do Sul
IMIP
Recife, Pernambuco, 50070-550
Hospital Barao de Lucena
Recife, Pernambuco, 50731-000
CISAM - Universidade de Pernambuco
Recife, Pernambuco, 52030-010
HC da Fac. de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14049-900
Hospital Maternidade Oswaldo de Nazareth
Rio de Janeiro, Rio de Janeiro, 20010-010
Hospital Maternidade Carmela Dutra
Rio de Janeiro, Rio de Janeiro, 20720-292
Hospital Maternidade Alexandre Fleming
Rio de Janeiro, Rio de Janeiro, 21610-645
Hospital Geral de Bonsucesso
Rio de Janeiro, Rio de Janeiro, 22040-000
Instituto Fernandes Figueira
Rio de Janeiro, Rio de Janeiro, 22250-020
Hospital Universitario - Unidade Materno Infantil
São Luís, Maranhão, 65020-460
Matern. Escola de Vila Nova Cachoeirinha
São Paulo, São Paulo, 01224-010
Instituto da Criança - HCFMUSP
São Paulo, São Paulo, 05403-900
Hospital Universitario - USP
São Paulo, São Paulo, 05508900
Hospital Esau de Matos
Vitória da Conquista, Estado de Bahia, 45065-540
About this study
Official title: Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants
The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.
Read the detailed description
Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.
Comparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Butantan, Control
- Keywords
- Respiratory distress syndrome, Pulmonary surfactant, Mortality, Prematurity
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButantanDrug
Also called Butantan Surfactant
Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses
ControlDrug
Also called Survanta or Curosurf
The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Butantan | Experimental | The new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses. Receives: Drug: Butantan |
| Control | Active comparator | The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Mortality rate 72 hours after treatment
Measured: 72 hours after treatment
Secondary outcomes (1)
The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).
Incidence of main complications of prematurity at 28 days of life.
Measured: 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startApr 2005
- Primary completionMay 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Celso Moura Rebello, University of Sao Paulo
- Investigators
- Alexander R Precioso, MD PhD, Study director, University of Sao Paulo Medical School Department of PediatricsCelso M Rebello, MD PhD, Principal investigator, University of Sao Paulo Medical School - Department of PediatricsRenata S Mascaretti, MD PhD, Study director, University of Sao Paulo Medical School Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305160
- Sponsor's protocol ID
- 012005B
- Status last verified
- Nov 2014
- First submitted
- 26 Feb 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Precioso AR, Sakae PP, Mascaretti RS, Kubrusly FS, Gebara VC, Iourtov D, Rebello CM, Vaz FA, Raw I. Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits. Clinics (Sao Paulo). 2006 Apr;61(2):153-60. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.
PubMed 16680333Lyra JC, Mascaretti RS, Precioso AR, Haddad LB, Mauad T, Vaz FA, Rebello CM. Polyethylene glycol addition does not improve exogenous surfactant function in an experimental model of meconium aspiration syndrome. Exp Lung Res. 2009 Feb;35(1):76-88. doi: 10.1080/01902140802415837.
PubMed 19191106Rebello CM, Precioso AR, Mascaretti RS; Grupo Colaborativo do Estudo Brasileiro Multicentrico de Surfactante. A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):397-404. doi: 10.1590/S1679-45082014AO3095.
PubMed 25628188
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Multicenter, Randomized, Open Label Trial of a New Low Cost Animal Extracted Surfactant to Treat Respiratory Distress Syndrome in Preterm Infants
- ClinicalTrials.gov ID
- NCT02305160
- Acronym / sponsor ID
- 012005B
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Respiratory distress syndrome, Pulmonary surfactant, Mortality, Prematurity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Apr 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy and safety of the new pulmonary surfactant produced by Butantan Institute among premature infants with gestational age below 34 weeks with RDS, comparing to the pulmonary surfactants commercially available in Brazil.
Detailed description
Exogenous surfactant replacement therapy has been one of the major advances in the treatment of premature infants with respiratory distress syndrome (RDS). It has decreased the mortality among premature infants with RDS, determining changes in the children mortality rates among the developed countries. High cost, however, has been a major handicap for its wide use in developing and underdeveloped countries. Based on that, Butantan Institute (Sao Paulo, Brazil) has developed a new porcine pulmonary surfactant preparation at lower production cost. Initial animal studies showed similar improvement in lung mechanics and histopathologic findings to those observed with commercially available preparations.
Comparison(s): The new surfactant developed and produced by Butantan Institute will be compared to the commercially available pulmonary surfactants in Brazil, regarding to the efficiency to maintain a good arterial oxygenation, low airway pressures after treatment, similar mortality rates, and similar rates of complications like bronchopulmonary dysplasia and pulmonary hemorrhage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butantan | Experimental | Drug: ButantanThe new pulmonary surfactant produced by Butantan Institute. Butantan Surfactant: 100 mg/kg, IT, maximum of 3 doses. |
| Control | Active comparator | Drug: ControlThe pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses. |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age below 34 weeks
- RDS diagnosis based on clinical and RDS radiographic patterns
- Need of mechanical ventilation
- Parental consent
Key exclusion criteria (5 listed)
- Age greater than 24 hours
- Major congenital malformations
- Unstable hemodynamic status
- Occurence of seizure during the stay in the Neonatal Intensive Care Unit
- Maternal and/or fetal infection (chorioamnionitis: maternal fever, foul vaginal discharge, fetal tachycardia, uterine tenderness, leukocytosis or leukopenia) or congenital infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ButantanAlso: Butantan SurfactantUse of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses | Drug | Butantan |
| ControlAlso: Survanta or CurosurfThe pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses. | Drug | Control |
Primary outcome
Mortality rate
Time frame: 72 hours after treatment
Mortality rate 72 hours after treatment
1 secondary outcome
The incidence of adverse effects as: pneumothorax, pneumomediastinum, pulmonary interstitial emphysema, pulmonary hemorrhage and bronchopulmonary dysplasia (BPD).
Time frame: 28 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 16680333Precioso AR, Sakae PP, Mascaretti RS, Kubrusly FS, Gebara VC, Iourtov D, Rebello CM, Vaz FA, Raw I. Analysis of the immunogenicity and stability of a porcine pulmonary surfactant preparation administered in rabbits. Clinics (Sao Paulo). 2006 Apr;61(2):153-60. doi: 10.1590/s1807-59322006000200011. Epub 2006 Apr 25.
- Background: PubMed 19191106Lyra JC, Mascaretti RS, Precioso AR, Haddad LB, Mauad T, Vaz FA, Rebello CM. Polyethylene glycol addition does not improve exogenous surfactant function in an experimental model of meconium aspiration syndrome. Exp Lung Res. 2009 Feb;35(1):76-88. doi: 10.1080/01902140802415837.
- Derived from this study: PubMed 25628188Rebello CM, Precioso AR, Mascaretti RS; Grupo Colaborativo do Estudo Brasileiro Multicentrico de Surfactante. A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):397-404. doi: 10.1590/S1679-45082014AO3095.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander R Precioso, MD PhD study director
University of Sao Paulo Medical School Department of Pediatrics
Celso M Rebello, MD PhD principal investigator
University of Sao Paulo Medical School - Department of Pediatrics
Renata S Mascaretti, MD PhD study director
University of Sao Paulo Medical School Department of Pediatrics
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Butantan in people with Respiratory Distress Syndrome, run by University of Sao Paulo at 30 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 72 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.