Status:
COMPLETED
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
Lead Sponsor:
Edgardo Szyld
Collaborating Sponsors:
University of Alabama at Birmingham
Conditions:
Resuscitation
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE3
Brief Summary
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation \[PPV\]) for res...
Detailed Description
Design: A multicenter cross-over cluster randomized controlled trial. Our hypothesis is based on the assumption that ventilating depressed newborns with a T-piece resuscitator will be more effective t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Live-born infants of ≥ 26 weeks' GA with HR \< 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations
- Exclusion Criteria:
- Infants requiring intubation from birth. Newborns of \< 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT00443118
Start Date
December 1 2009
End Date
August 1 2012
Last Update
September 28 2018
Active Locations (11)
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1
Carol Jo Vecchie Women and Children's Center at St. John's Hospital
Springfield, Illinois, United States, 19676
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
3
Sanatorio de los Arcos
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425FSD
4
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina