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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00501982
Other study ID # DM/PR/5000/002/04
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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