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

Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443118
• Other study ID #: Fundasamin 102
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2018
• Source: Fundacion para la Salud Materno Infantil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Other known NCT identifiers

• NCT01126489

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Minutes

Eligibility

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.

Related Conditions & MeSH terms

• Resuscitation

Intervention

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.
• 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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Edgardo Szyld	University of Alabama at Birmingham

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Italy,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Infants With a HR = 100 Bpm at 2 Minutes of Life.		2 minutes of life
Secondary	Time the Newborn Takes to Reach a HR > 100 Bpm		2 minutes of life
Secondary	• SpO2 Value at 2 Minutes of Life.		2 minutes of life
Secondary	• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.		after 2 minutes of life
Secondary	• Need for Chest Compression and/or Medications		after 2 minutes of life
Secondary	Apgar Scores at 1 and 5 Minutes	categorized Apgar score 1 min <=3 and categorized Apgar score 5 min <=5 The Apgar score is applied routinely by nurses and neonatologists to describe how vigorous the baby is at birth, it ranges from 0 to 10, with higher scores representing better outcomes.	1-5 minutes of life
Secondary	• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)		first week of life
Secondary	• Incidence of Air Leaks	included pneumothorax and Pneumomediastinum	after birth and during hospitalization up to four weeks
Secondary	• Use of Oxygen Treatment Beyond the Delivery Room		during hospitalization
Secondary	Days on Oxygen		after birth and during hospitalization up to four weeks
Secondary	• Need for Mechanical Ventilation or CPAP		during hospitalization
Secondary	Days on Mechanical Ventilation		after delivery and before four weeks
Secondary	Days on CPAP		after birth and during hospitalization up to four weeks
Secondary	• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks	Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation	1 day of life and 30 days after birth

External Links

•   this paper was published on The Journal of Pediatrics