CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,032 enrolled
Drug / intervention
T-piece resuscitator Neopuff TM +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00443118
NCT00443118Phase 3Completed
CompareCT.gov

NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial

Edgardo Szyld·interventional·Posted Mar 5, 2007·Updated Sep 28, 2018

In Brief

A Phase 3 clinical trial evaluating T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP, and 1 other intervention for Resuscitation. Completed, enrolled 1,032 participants across 11 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResuscitation
CountriesArgentina, Chile, Italy, Peru, United States
CollaboratorsUniversity of Alabama at Birmingham

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2007
Enrollment StartDec 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.3 years ago

Interventions

T-piece resuscitator Neopuff TMdevice

Positive pressure ventilation will be performed with Neopuff® with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.

Self Inflating Bag with PEEPdevice

Positive pressure ventilation will be performed with Self Inflating Bag with PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.

Self Inflating Bag without PEEPdevice

Positive pressure ventilation will be performed with Self Inflating Bag without PEEP with face mask. For this study, an initial PIP 25 cm H2O and a 5 cm H2O PEEP will be used for resuscitation according to protocol.