Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
03/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arjan B. Pas, te

ORCID ID

Contact details

Department of Pediatrics
Leiden University Medical Center
J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262909
a.b.te_pas@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EFURCI

Study hypothesis

A sustained inflation with a mechanical device and early nasal continuous positive airway pressure is a more effective management strategy for RDS in preterm infants than conventional intervention with a self-inflating mask and bag, and reduces the requirement for mechanical ventilation and surfactant treatment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory Distress Syndrome, Preterm neonates

Intervention

Resuscitation at birth when necessary:
Group A: Prolonged inflation of 10 seconds with a mechanical device (Neopuff t-piece resuscitator) and early CPAP treatment.
Group B: Inflation with self-inflating mask and bag conform international resuscitation guidelines.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Need of endotracheal intubation within 3 days after birth.

Secondary outcome measures

1. Death
2. Bronchopulmonary Dysplasia (BPD)

Overall trial start date

01/04/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preterm neonates
2. Gestational age range 25 - 32 weeks (more than 24 weeks and 6 days and not more than 32 weeks and 6 days)

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Antenatal diagnosed congenital anomalies of the cardio or respiratory system or anomalies incompatible with survival.

Recruitment start date

01/04/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Pediatrics, Leiden University Medical Center, J6-S, P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17671058

Publication citations

  1. Results

    te Pas AB, Walther FJ, A randomized, controlled trial of delivery-room respiratory management in very preterm infants., Pediatrics, 2007, 120, 2, 322-329, doi: 10.1542/peds.2007-0114.

Additional files

Editorial Notes