CompletedPhase 3

Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?

United States, Argentina1,032 participantsStarted 2009-12

Plain-language 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 resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.

Who can participate

Age range2 Minutes

SexALL

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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.

What they're measuring

Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.

Timeframe: 2 minutes of life

Trial details

NCT IDNCT00443118

SponsorEdgardo Szyld

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

Results submitted2014-02-22

View on ClinicalTrials.gov More Resuscitation trials