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

Completed · Phase 3

Conditions studied: Resuscitation

In brief

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.

Key facts

Study ID: NCT00443118
Run by: Edgardo Szyld
People needed: 1032
Starts: 2009-12-01
Expected to finish: 2012-08-01
Last updated by the study team: 2018-09-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Carol Jo Vecchie Women and Children's Center at St. John's Hospital — Springfield, Illinois, United States
Cleveland Clinic — Cleveland, Ohio, United States
Sanatorio de los Arcos — Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral — Pilar, Buenos Aires, Argentina
Hospital Misericordia — Córdoba, Argentina
Nuevo Hospital El Milagro de Salta — Salta, Argentina
Hospital Clínico de la Pontificia Universidad Católica de Chile — Santiago, Chile
Hospital Dr. Hernán Henriquez Aravena — Temuco, Chile
Hospital Dr. Gustavo Fricke — Viña del Mar, Chile
Azienda Ospedaliera Padova — Padova, Veneto, Italy
Instituto Nacional Materno Perinatal (INMP) de Perú — Lima, Peru

Full record on ClinicalTrials.gov

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