Clinical trial NCT00501982: Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: surfactant
RDS
nCPAP
Mechanical Ventilation
Premature Infants
Neonatal Respiratory Distress Syndrome (nRDS)
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 208
Sex: ALL
Minimum age (years): 25
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Need for MV
timeFrame: Within the first 5 days of life
Secondary outcomes:
measure: Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home
timeFrame: entire study
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General Faculty Hospital
city: Marseille
country: France
facility: Hopital De La Conception
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Lisbon
country: Portugal
facility: Maternidade Alfredo da Costa
city: Bilbao
country: Spain
facility: Hospital De Cruces
Study officials:
affiliation: Medical Department; Chiesi Farmaceutici S.p.A (Italy)
name: Laura Fabbri
role: STUDY_DIRECTOR
References:
citation: 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.