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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17671058
Publication citations
-
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.