Respiratory Distress SyndromeNEOSURFNCT02834624
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
A study testing Poractant alfa and calfactant in people with Respiratory Distress Syndrome, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. Read more about this study
- Who is it for?
- Ages 22 to 35 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Poractant alfa and calfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2015
- Phase
- Interventional
- 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 22 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled prior to delivery with signed informed consent and HIPAA by parents
- Gestational age of less than 35 weeks
- No maternal chorioamnionitis of other maternal or fetal infection
- Respiratory Distress Syndrome (RDS) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation
Who cannot join
- Major Birth Defect, Malformation Syndrome
- Chromosomal or Inherited Metabolic Disorder
- Proven Presence of an Immunodeficiency
- Antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana)
- Birth Asphyxia (cord pH <7.0, Apgar score of 3 or less at 10 minutes of age)
- HIV or other congenital viral, bacterial or fungal infection
Show all 9Show fewer
- Lack of Parental consent of refusal of attending neonatologist to allow participation
- Discretion of the investigator
- The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, Women's and Children's Hospital
Columbia, Missouri, 65201
About this study
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.
Read the detailed description
30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.
Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Poractant alfa, calfactant
- Keywords
- surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation
- Medical subject headings
- Respiratory Distress Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfaDrug
Also called Curosurf
Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
calfactantDrug
Also called Infasurf
Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist
| Study group | Role | What they receive |
|---|---|---|
| Calfactant | Active comparator | Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. Receives: Drug: calfactant |
| Poractant Alfa | Active comparator | Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. Receives: Drug: Poractant alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood C-reactive (CRP) Protein
Difference between measurement of CRP at baseline and 48 hours after administration of surfactant
Measured: baseline, 48 hours
Secondary outcomes (2)
Presence of Pulmonary Hemorrhage
Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.
Measured: intraoperative
Change in Number of Tracheal Macrophages
measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate
Measured: baseline, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionJul 2015
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.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Lauriello, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834624
- Sponsor's protocol ID
- 1206415
- Acronym
- NEOSURF
- Status last verified
- May 2017
- First submitted
- 19 May 2016
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02834624
- Acronym / sponsor ID
- NEOSURF / 1206415
- Conditions
- Respiratory Distress Syndrome
- Keywords
- surfactant, respiratory distress syndrome, inflammation, c-reactive protein, lipid peroxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.
The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.
Detailed description
30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.
Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calfactant | Active comparator | Drug: calfactantRandomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
| Poractant Alfa | Active comparator | Drug: Poractant alfaRandomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. |
Who may qualify
- Ages
- 22 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Enrolled prior to delivery with signed informed consent and HIPAA by parents
- Gestational age of less than 35 weeks
- No maternal chorioamnionitis of other maternal or fetal infection
- Respiratory Distress Syndrome (RDS) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation
Key exclusion criteria (9 listed)
- Major Birth Defect, Malformation Syndrome
- Chromosomal or Inherited Metabolic Disorder
- Proven Presence of an Immunodeficiency
- Antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana)
- Birth Asphyxia (cord pH <7.0, Apgar score of 3 or less at 10 minutes of age)
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 |
|---|---|---|
| Poractant alfaAlso: CurosurfRandomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist. | Drug | Poractant Alfa |
| calfactantAlso: InfasurfRandomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist | Drug | Calfactant |
Primary outcome
Change From Baseline in Blood C-reactive (CRP) Protein
Time frame: baseline, 48 hours
Difference between measurement of CRP at baseline and 48 hours after administration of surfactant
2 secondary outcomes
Presence of Pulmonary Hemorrhage
Time frame: intraoperative
Change in Number of Tracheal Macrophages
Time frame: baseline, 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Naomi Lauriello, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poractant alfa and calfactant in people with Respiratory Distress Syndrome, run by University of Missouri-Columbia 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 4 inclusion and 9 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 6 Jun 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). 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?
Change From Baseline in Blood C-reactive (CRP) Protein (time frame: baseline, 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2017.