NCT00501982

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. 1.Early stabilization on nCPAP
  2. 2.Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2007

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

July 16, 2007

Last Update Submit

July 30, 2020

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

surfactantRDSnCPAPMechanical VentilationPremature InfantsNeonatal Respiratory Distress Syndrome (nRDS)

Outcome Measures

Primary Outcomes (1)

  • Need for MV

    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

    entire study

Study Arms (2)

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

Drug: Poractant alfa (Curosurf®)

Interventions

Poractant alfa (Curosurf®)DRUG
2

Eligibility Criteria

Age25 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

General Faculty Hospital

Prague, Czechia

Location

Hopital De La Conception

Marseille, France

Location

Ospedale Maggiore

Bologna, Italy

Location

Maternidade Alfredo da Costa

Lisbon, Portugal

Location

Hospital De Cruces

Bilbao, Spain

Location

Related 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;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.

    PMID: 20439601RESULT

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Laura Fabbri

    Medical Department; Chiesi Farmaceutici S.p.A (Italy)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

FR(1)ES(1)PT(1)IT(1)CZ(1)