Newborn Ventilation in the Delivery Room: Could it be Improved With a

Status Completed

Clinical Trial 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.

Clinical Trial 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 than SIB by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.

Population: Newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (PPV) for resuscitation in the delivery room.

(need for assisted ventilation at positive pressure: Heart Rate [HR] < 100 beats per minute [bpm], apnea, gasping, cyanosis and/or hypotonia)

Intervention: PPV will be performed with a T-piece resuscitator (Neopuff® group) with positive end expiratory pressure.

Control: PPV will be performed with a self inflating bag (SIB group) with and without PEEP.

Both devices will be used with face masks, and a peak inspiratory pressure (PIP) of 25 cm H2O will be used to begin ventilation with PEEP of 0 cm H2O in the subgroup without PEEP valve, 5 cm H2O in the subgroup with PEEP valve in the SIB group, and 5 cm H2O in the Neopuff® group.

Objective: To compare the effectiveness of both instruments in reaching a heart rate of ≥ 100 bpm in depressed newborns of ≥ 26 weeks' gestational age (GA) after the initiation of positive pressure ventilation (PPV) with face mask.

Primary Outcome: Proportion of newborns with HR ≥ 100 bpm at 2 minutes of life.

Type of Comparison: Which of the two devices Neopuff TM or Self Inflating Bag (NP/SIB)will be more effective for ventilation of the newborn, by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation. ;

Study Design

Related Conditions & MeSH terms

Resuscitation

Clinical Trial Details

NCT number	NCT00443118
Study type	Interventional
Source	Fundacion para la Salud Materno Infantil
Contact
Status	Completed
Phase	Phase 3
Start date	December 2009
Completion date	August 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms