Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study

Respiratory Distress Syndrome, Newborn Clinical Trial

— Curpap  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501982
• Other study ID #: DM/PR/5000/002/04
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 28 Weeks

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Poractant alfa (Curosurf®)

Locations

Country	Name	City	State
Czechia	General Faculty Hospital	Prague
France	Hopital De La Conception	Marseille
Italy	Ospedale Maggiore	Bologna
Portugal	Maternidade Alfredo da Costa	Lisbon
Spain	Hospital De Cruces	Bilbao

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Czechia,  France,  Italy,  Portugal,  Spain, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for MV		Within the first 5 days of life
Secondary	Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home		entire study

External Links

•   Study Record on EU Clinical Trials Register including results