Creating and maintaining functional residual capacity in preterm neonates with Respiratory Distress Syndrome (RDS)

ISRCTN ISRCTN12757724
DOI https://doi.org/10.1186/ISRCTN12757724
Secondary identifying numbers N/A
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
03/08/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Arjan B. Pas, te
Scientific

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

Phone +31 (0)71 5262909
Email a.b.te_pas@lumc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymEFURCI
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory Distress Syndrome, Preterm neonates
InterventionResuscitation 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 typeOther
Primary outcome measureNeed of endotracheal intubation within 3 days after birth.
Secondary outcome measures1. Death
2. Bronchopulmonary Dysplasia (BPD)
Overall study start date01/04/2005
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Target number of participants200
Key inclusion criteria1. 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)
Key exclusion criteriaAntenatal diagnosed congenital anomalies of the cardio or respiratory system or anomalies incompatible with survival.
Date of first enrolment01/04/2005
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

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

Website http://www.lumc.nl/
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Hospital/treatment centre

Leiden University Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/08/2007 Yes No