Respiratory Distress Syndrome, NewbornPhase 4CurpapNCT00501982
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
A Phase 4 study testing Poractant alfa (Curosurf®) in people with Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 5 sites in 5 countries.
Trial summary
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS: 1. Early stabilization on nCPAP 2. Read more about this study
- Who is it for?
- Ages 25 to 28 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Poractant alfa (Curosurf®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Mar 2007to May 2008
- Phase
- Phase 4
- 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 25 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates with a gestational age (GA) of 25+0 - 28+6 completed weeks.
- Inborn neonates.
- In case of twins, both neonates will be included in the same treatment arm.
- Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.
Who cannot join
- Evidence of severe birth asphyxia, that is an APGAR score below 3 at 5 minutes of age.
- Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive.
- Known genetic or chromosomal disorders.
- Delivered to mothers with ruptured membranes of more than 3 weeks duration.
- Potentially life-threatening conditions unrelated to immaturity.
- Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:
- Early stabilization on nCPAP
- Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.
The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Poractant alfa (Curosurf®)
- Keywords
- surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfa (Curosurf®)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | N Cpap in delivery room and than rescue curosurf in case of need |
| 2 | Experimental | Poractant alfa (Curosurf) + N Cpap in delivery room Receives: Drug: Poractant alfa (Curosurf®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for MV
Measured: Within the first 5 days of life
Secondary outcomes (1)
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
Measured: entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Fabbri, Study director, Medical Department; Chiesi Farmaceutici S.p.A (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501982
- Sponsor's protocol ID
- DM/PR/5000/002/04
- Acronym
- Curpap
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2007
- Last updated
- 3 Aug 2020
- Results posted
- No
Publications
Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.
PubMed 20439601
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00501982
- Acronym / sponsor ID
- Curpap / DM/PR/5000/002/04
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- surfactant, RDS, nCPAP, Mechanical Ventilation, Premature Infants, Neonatal Respiratory Distress Syndrome (nRDS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jul 2007 (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 primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:
- Early stabilization on nCPAP
- Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.
The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –N Cpap in delivery room and than rescue curosurf in case of need |
| 2 | Experimental | Drug: Poractant alfa (Curosurf®)Poractant alfa (Curosurf) + N Cpap in delivery room |
Who may qualify
- Ages
- 25 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm neonates with a gestational age (GA) of 25+0 - 28+6 completed weeks.
- Inborn neonates.
- In case of twins, both neonates will be included in the same treatment arm.
- Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.
Key exclusion criteria (6 listed)
- Evidence of severe birth asphyxia, that is an APGAR score below 3 at 5 minutes of age.
- Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive.
- Known genetic or chromosomal disorders.
- Delivered to mothers with ruptured membranes of more than 3 weeks duration.
- Potentially life-threatening conditions unrelated to immaturity.
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 alfa (Curosurf®) | Drug | 2 |
Primary outcome
Need for MV
Time frame: Within the first 5 days of life
1 secondary outcome
Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
Time frame: entire study
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 3 Aug 2020.
- Results publication: PubMed 20439601Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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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.
Laura Fabbri study director
Medical Department; Chiesi Farmaceutici S.p.A (Italy)
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poractant alfa (Curosurf®) in people with Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 5 sites in 5 countries.
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 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: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia, France, Italy, Portugal, Spain. 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?
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?
Need for MV (time frame: Within the first 5 days of life). 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 NCT00501982, which also lists 1 linked publication.
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 Aug 2020.