Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study (Curpap)
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|ClinicalTrials.gov Identifier: NCT00501982|
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : August 3, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome, Newborn||Drug: Poractant alfa (Curosurf®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
No Intervention: 1
N Cpap in delivery room and than rescue curosurf in case of need
Poractant alfa (Curosurf) + N Cpap in delivery room
Drug: Poractant alfa (Curosurf®)
- Need for MV [ Time Frame: Within the first 5 days of life ]
- Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home [ Time Frame: entire study ]
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|Ages Eligible for Study:||25 Weeks to 28 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501982
|General Faculty Hospital|
|Hopital De La Conception|
|Maternidade Alfredo da Costa|
|Hospital De Cruces|
|Study Director:||Laura Fabbri||Medical Department; Chiesi Farmaceutici S.p.A (Italy)|
Publications of Results:
|Responsible Party:||Chiesi Farmaceutici S.p.A.|
|Other Study ID Numbers:||
|First Posted:||July 17, 2007 Key Record Dates|
|Last Update Posted:||August 3, 2020|
|Last Verified:||July 2020|
Neonatal Respiratory Distress Syndrome (nRDS)
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory System Agents