MedTrace Logo

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

NCT00443118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2018-09-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Resuscitation

Interventions

DEVICE

T-piece resuscitator Neopuff TM

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.

DEVICE

Self Inflating Bag with PEEP

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.

DEVICE

Self Inflating Bag without PEEP

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Edgardo Szyld

    lead OTHER

Principal Investigators

  • Edgardo Szyld, MD · Fundasamin

  • Adriana Aguilar, MD · Hospital Paroissien

  • Waldemar Carlo, MD · University of Alabama at Birmingham

  • Nestor Vain, MD · Sanatorio de la Trinidad

  • Luis Prudent, MD · Sanatorio Otamendi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Argentina
  • Chile
  • Italy
  • Peru

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443118 on ClinicalTrials.gov