Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
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|ClinicalTrials.gov Identifier: NCT00443118|
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : March 31, 2015
Last Update Posted : September 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Resuscitation||Device: T-piece resuscitator Neopuff TM Device: Self Inflating Bag with PEEP Device: Self Inflating Bag without PEEP||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1032 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Active Comparator: Neopuff TM with PEEP
Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP
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.
Active Comparator: Self Inflating Bag with PEEP
Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached
Device: 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.
Other Name: Ambu
Active Comparator: Self Inflating Bag without PEEP
Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached
Device: 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 Name: Ambu
- Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. [ Time Frame: 2 minutes of life ]
- Time the Newborn Takes to Reach a HR > 100 Bpm [ Time Frame: 2 minutes of life ]
- • SpO2 Value at 2 Minutes of Life. [ Time Frame: 2 minutes of life ]
- • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. [ Time Frame: after 2 minutes of life ]
- • Need for Chest Compression and/or Medications [ Time Frame: after 2 minutes of life ]
- Apgar Scores at 1 and 5 Minutes [ Time Frame: 1-5 minutes of life ]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.
- • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) [ Time Frame: first week of life ]
- • Incidence of Air Leaks [ Time Frame: after birth and during hospitalization up to four weeks ]included pneumothorax and Pneumomediastinum
- • Use of Oxygen Treatment Beyond the Delivery Room [ Time Frame: during hospitalization ]
- Days on Oxygen [ Time Frame: after birth and during hospitalization up to four weeks ]
- • Need for Mechanical Ventilation or CPAP [ Time Frame: during hospitalization ]
- Days on Mechanical Ventilation [ Time Frame: after delivery and before four weeks ]
- Days on CPAP [ Time Frame: after birth and during hospitalization up to four weeks ]
- • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks [ Time Frame: 1 day of life and 30 days after birth ]Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443118
|United States, Illinois|
|Carol Jo Vecchie Women and Children's Center at St. John's Hospital|
|Springfield, Illinois, United States, 19676|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Sanatorio de los Arcos|
|Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425FSD|
|Hospital Universitario Austral|
|Pilar, Buenos Aires, Argentina|
|Nuevo Hospital El Milagro de Salta|
|Salta, Argentina, 4400|
|Hospital Clínico de la Pontificia Universidad Católica de Chile|
|Santiago de Chile, Chile, 8330024|
|Hospital Dr. Hernán Henriquez Aravena|
|Hospital Dr. Gustavo Fricke|
|Viña del Mar, Chile|
|Azienda Ospedaliera Padova|
|Padova, Veneto, Italy, 35128|
|Instituto Nacional Materno Perinatal (INMP) de Perú|
|Principal Investigator:||Edgardo Szyld, MD||Fundasamin|
|Study Director:||Adriana Aguilar, MD||Hospital Paroissien|
|Study Chair:||Waldemar Carlo, MD||University of Alabama at Birmingham|
|Study Director:||Nestor Vain, MD||Sanatorio de la Trinidad|
|Study Director:||Luis Prudent, MD||Sanatorio Otamendi|