Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
NCT ID: NCT00443118
Last Updated: 2018-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1032 participants
INTERVENTIONAL
2009-12-31
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neopuff TM with PEEP
Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP
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
Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached
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
Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Minutes
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Edgardo Szyld
OTHER
Responsible Party
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Edgardo Szyld
Principal Investigator
Principal Investigators
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Edgardo Szyld, MD
Role: PRINCIPAL_INVESTIGATOR
Fundasamin
Adriana Aguilar, MD
Role: STUDY_DIRECTOR
Hospital Paroissien
Waldemar Carlo, MD
Role: STUDY_CHAIR
University of Alabama at Birmingham
Nestor Vain, MD
Role: STUDY_DIRECTOR
Sanatorio de la Trinidad
Luis Prudent, MD
Role: STUDY_DIRECTOR
Sanatorio Otamendi
Locations
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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
Padua, Veneto, Italy
Instituto Nacional Materno Perinatal (INMP) de Perú
Lima, , Peru
Countries
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References
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Szyld E, Aguilar A, Musante GA, Vain N, Prudent L, Fabres J, Carlo WA; Delivery Room Ventilation Devices Trial Group. Comparison of devices for newborn ventilation in the delivery room. J Pediatr. 2014 Aug;165(2):234-239.e3. doi: 10.1016/j.jpeds.2014.02.035. Epub 2014 Mar 29.
Related Links
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this paper was published on The Journal of Pediatrics
Other Identifiers
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Fundasamin 102
Identifier Type: -
Identifier Source: org_study_id
NCT01126489
Identifier Type: -
Identifier Source: nct_alias
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