PrematurityPhase 4CASTNCT00767039

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

A Phase 4 study testing Survanta (beractant) and Curosurf (poractant) in people with Prematurity and Respiratory Distress Syndrome, run by Alan Fujii at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages Up to 8 hours
Conditions the study is for: Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
What is being tested?: Survanta (beractant) and Curosurf (poractant)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Jan 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 8 hours
All sexes
No healthy volunteers
Child

Who may be able to join

<29 6/7 and >24 0/7 weeks gestational age
Inborn at the participating institution enrolling the patient
FIO2 >25% and Intubated with mean airway pressure > 5 cm H20
<8 hours age at randomization
Signed informed consent from parent(s)

Who cannot join

<500 g birth weight
<24 0/7 weeks gestational age (best estimate)
Prolonged Premature Rupture of membranes >3 weeks (21 days)
Apgar score < 3 at 5 minutes
Impending death anticipated within the first 3 days of life, moribund
Severe congenital anomalies

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Medical Center
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Phase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates.

The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

Read the detailed description

Specific Aims:

To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta
To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta
To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta
To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta

We reasoned that if Curosurf was primarily responsible for improved survival rates, compared with Survanta, then there should be a sustained improvement in respiratory function in the first three days of life, when the direct pulmonary effects of the surfactant preparations would be most easily detected. It was also possible that Curosurf and Survanta could have effects on other systems that could secondarily affect long-term survival of the infant. These other organ systems would include, but not be limited to, the development of a hemodynamically significant Patent Ductus Arteriosus, Intraventricular Hemorrhage or Periventricular Leukomalacia, or Necrotizing Enterocolitis. We propose to examine how surfactant administration affected the hemodynamic precursors of these common morbidities of very premature infants.

Conditions: Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
Being tested: Survanta (beractant), Curosurf (poractant)
Keywords: Very Premature, RDS, Surfactant
Medical subject headings: Premature Birth, Respiratory Distress Syndrome, Ductus Arteriosus, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Survanta (beractant)Drug
Also called Survanta
beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)
Curosurf (poractant)Drug
Also called Curosurf
poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)

Study groups in NCT00767039
Study group	Role	What they receive
1	Active comparator	Surfactant (beractant, Survanta initial dose 100 mg/kg and subsequent doses 100 mg/kg phospholipids every 6-12 hours, as needed for up to 4 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation Receives: Drug: Survanta (beractant)
2	Experimental	Surfactant (poractant, Curosurf initial dose 200 mg/kg and subsequent doses 100 mg/kg phospholipids every 12-24 hours as needed for up to 3 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation Receives: Drug: Curosurf (poractant)

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.
Measured: 48 hours after surfactant administration
Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.
Measured: 72 hours after surfactant administration
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Measured: 48 hours after surfactant administration
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Measured: 72 hours after surfactant administration

Secondary outcomes (7)

Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Measured: 48 hours after surfactant administration
Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.
Measured: 72 hours after surfactant administration
Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)
Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.
Measured: Hemodynamically significant PDA at > 2 days
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)
Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.
Measured: First hour after 2nd surfactant dose
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.
Measured: One hour following second surfactant dose at 12-24 hours after initial dose
Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)
Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.
Measured: 36 weeks post menstrual age
Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.
Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.
Measured: NICU hospitalization, up to 42 weeks post menstrual age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jan 2009

First posted6 Oct 2008 (estimated)
Study startJan 2005
Primary completionSep 2008
Study completionJan 2009

Why it stopped: Slow recruitment,changes in protocols, larger than anticipated differences

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PrematurityStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00767039
Sponsor's protocol ID: H-23371
Acronym: CAST
Status last verified: Oct 2008
First submitted: 17 Dec 2007
Last updated: 3 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90
Fujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51.
Fujii AM, Carillo M. Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 10.1358/dot.2009.45.9.1418185.
PubMed 19956811
Fujii AM, Patel SM, Allen R, Doros G, Guo CY, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25.
PubMed 20336076
Fujii A, Allen R, Doros G, O'Brien S. Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):671-6. doi: 10.1038/jp.2010.21. Epub 2010 Mar 25.
PubMed 20336077
Fujii AM, Bailey J, Doros G, Sampat K, Sikes NC, Mason M, Kaiser JR. Cerebral Blood Flow Responses to Beractant and Poractant Administration. Journal of Neonatal-Perinatal Medicine 2009; 2:27-34

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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All Prematurity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Curosurf (Poractant) and Survanta (Beractant) Surfactant Treatment in Very Premature Infants With Respiratory Distress Syndrome.
ClinicalTrials.gov ID: NCT00767039
Acronym / sponsor ID: CAST / H-23371
Conditions: Prematurity, Respiratory Distress Syndrome, Patent Ductus Arteriosus
Keywords: Very Premature, RDS, Surfactant
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment,changes in protocols, larger than anticipated differences
Enrolment: 52 participants (actual)
Lead sponsor: Alan FujiiUniversity, hospital or other
Collaborators: Dey LP
Study start: Jan 2005
Primary completion: Sep 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 6 Oct 2008 (estimated)
Results: Posted 20 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aims:

To determine whether there is a sustained difference in the level of respiratory support during the first 3 days of life in extremely premature infants treated with Curosurf versus Survanta
To determine whether Curosurf is associated with a higher incidence of hemodynamically significant PDA, compared with Survanta
To determine whether there is a difference in the cerebral blood flow response to Curosurf versus Survanta
To determine whether there is a difference in morbidity in very premature infants treated with Curosurf versus Survanta

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Survanta (beractant)Surfactant (beractant, Survanta initial dose 100 mg/kg and subsequent doses 100 mg/kg phospholipids every 6-12 hours, as needed for up to 4 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation
2	Experimental	Drug: Curosurf (poractant)Surfactant (poractant, Curosurf initial dose 200 mg/kg and subsequent doses 100 mg/kg phospholipids every 12-24 hours as needed for up to 3 doses), intratracheal administration to very premature infants with RDS requiring mechanical ventilation

Who may qualify

Ages: Up to 8 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

<29 6/7 and >24 0/7 weeks gestational age
Inborn at the participating institution enrolling the patient
FIO2 >25% and Intubated with mean airway pressure > 5 cm H20
<8 hours age at randomization
Signed informed consent from parent(s)

Key exclusion criteria (6 listed)

<500 g birth weight
<24 0/7 weeks gestational age (best estimate)
Prolonged Premature Rupture of membranes >3 weeks (21 days)
Apgar score < 3 at 5 minutes
Impending death anticipated within the first 3 days of life, moribund

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
Survanta (beractant)Also: Survantaberactant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses)	Drug	1
Curosurf (poractant)Also: Curosurfporactant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)	Drug	2

Primary outcome

Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Time frame: 48 hours after surfactant administration
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.
Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration
Time frame: 72 hours after surfactant administration
Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.
Time frame: 48 hours after surfactant administration
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.
Time frame: 72 hours after surfactant administration
Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.

7 secondary outcomes

Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Time frame: 48 hours after surfactant administration
Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups
Time frame: 72 hours after surfactant administration
Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)
Time frame: Hemodynamically significant PDA at > 2 days
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)
Time frame: First hour after 2nd surfactant dose
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant
Time frame: One hour following second surfactant dose at 12-24 hours after initial dose
Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)
Time frame: 36 weeks post menstrual age
Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.
Time frame: NICU hospitalization, up to 42 weeks post menstrual age

Results and safety

Results posted to the registry on 20 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Beractant Arm	27	22
Poractant Alfa Arm	25	23

Primary outcome: Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.

Time frame: 48 hours after surfactant administration. Mean (Standard Error). Unit: cm H20

Measure	Beractant Arm n = 25	Poractant Alfa Arm n = 25
Value	8.6 (0.8)	6.4 (0.4)

Beractant Arm vs Poractant Alfa Arm: p < 0.05, t-test, 2 sided

Population analysed: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.

Primary outcome: Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration

Time frame: 72 hours after surfactant administration. Mean (Standard Error). Unit: cm H20

Measure	Beractant Arm n = 25	Poractant Alfa Arm n = 25
Value	7.9 (0.6)	6.0 (0.7)

Beractant Arm vs Poractant Alfa Arm: p <0.05, t-test, 2 sided

Primary outcome: Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.

Time frame: 48 hours after surfactant administration. Mean (Standard Error). Unit: cm H20-Percent of O2

Measure	Beractant Arm n = 25	Poractant Alfa Arm n = 25
Value	274 (35)	170 (18)

Beractant Arm vs Poractant Alfa Arm: p <0.05, t-test, 2 sided

Primary outcome: Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.

Time frame: 72 hours after surfactant administration. Mean (Standard Error). Unit: cm H20-Percent of O2

Measure	Beractant Arm n = 25	Poractant Alfa Arm n = 25
Value	226 (29)	140 (16)

Beractant Arm vs Poractant Alfa Arm: p <0.05, t-test, 2 sided

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Beractant Arm	19 of 27 (70.4%)	17 of 27 (63%)	Not reported
Poractant Alfa Arm	9 of 25 (36%)	8 of 25 (32%)	Not reported

Limitations and caveats (from the sponsor): The primary limitations are the small number of patients, the high rate of chronic lung disease in the beractant group and the open-label design of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundFujii AM, Editorial. Is There Really A Clinical Difference In Surfactant Preparations? J Perinatol 2010; 30:698; doi:10,1038/jp.2010.90
BackgroundFujii A. Editorial. Are all animal derived surfactants the same? The e-NeoResearch 2011; 1 (1); 50-51.
Results publication: PubMed 19956811Fujii AM, Carillo M. Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 10.1358/dot.2009.45.9.1418185.
Results publication: PubMed 20336076Fujii AM, Patel SM, Allen R, Doros G, Guo CY, Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):665-70. doi: 10.1038/jp.2010.20. Epub 2010 Mar 25.
Results publication: PubMed 20336077Fujii A, Allen R, Doros G, O'Brien S. Patent ductus arteriosus hemodynamics in very premature infants treated with poractant alfa or beractant for respiratory distress syndrome. J Perinatol. 2010 Oct;30(10):671-6. doi: 10.1038/jp.2010.21. Epub 2010 Mar 25.
Results publicationFujii AM, Bailey J, Doros G, Sampat K, Sikes NC, Mason M, Kaiser JR. Cerebral Blood Flow Responses to Beractant and Poractant Administration. Journal of Neonatal-Perinatal Medicine 2009; 2:27-34

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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.

Alan M Fujii, MD principal investigator

Boston Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Survanta (beractant) and Curosurf (poractant) in people with Prematurity and Respiratory Distress Syndrome, run by Alan Fujii at 1 site in United States.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration. (time frame: 48 hours after surfactant administration). The study lists 4 primary outcomes in all. 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 NCT00767039, which also lists 6 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 3 Oct 2011.