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

Edgardo Szyld

Status and phase: Completed; Phase 3

Conditions: Resuscitation

Treatments: Device: T-piece resuscitator Neopuff TM; Device: Self Inflating Bag with PEEP; Device: Self Inflating Bag without PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT00443118

Fundasamin 102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,032 patients

Sex: All

Ages: Under 2 minutes old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,032 participants in 3 patient groups

Neopuff TM with PEEP

Active Comparator group

Description:

Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP

Treatment:

Device: T-piece resuscitator Neopuff TM

Self Inflating Bag with PEEP

Active Comparator group

Description:

Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached

Treatment:

Device: Self Inflating Bag with PEEP

Self Inflating Bag without PEEP

Active Comparator group

Description:

Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached

Treatment:

Device: Self Inflating Bag without PEEP