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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00443118
Recruitment Status : Completed
First Posted : March 5, 2007
Results First Posted : March 31, 2015
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Edgardo Szyld, Fundacion para la Salud Materno Infantil

Brief 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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. [ Time Frame: 2 minutes of life ]

Secondary Outcome Measures :
  1. Time the Newborn Takes to Reach a HR > 100 Bpm [ Time Frame: 2 minutes of life ]
  2. • SpO2 Value at 2 Minutes of Life. [ Time Frame: 2 minutes of life ]
  3. • 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 ]
  4. • Need for Chest Compression and/or Medications [ Time Frame: after 2 minutes of life ]
  5. 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.

  6. • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) [ Time Frame: first week of life ]
  7. • Incidence of Air Leaks [ Time Frame: after birth and during hospitalization up to four weeks ]
    included pneumothorax and Pneumomediastinum

  8. • Use of Oxygen Treatment Beyond the Delivery Room [ Time Frame: during hospitalization ]
  9. Days on Oxygen [ Time Frame: after birth and during hospitalization up to four weeks ]
  10. • Need for Mechanical Ventilation or CPAP [ Time Frame: during hospitalization ]
  11. Days on Mechanical Ventilation [ Time Frame: after delivery and before four weeks ]
  12. Days on CPAP [ Time Frame: after birth and during hospitalization up to four weeks ]
  13. • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
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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 Clinic
Cleveland, Ohio, United States, 44195
Argentina
Sanatorio de los Arcos
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425FSD
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Hospital Misericordia
Córdoba, Argentina
Nuevo Hospital El Milagro de Salta
Salta, Argentina, 4400
Chile
Hospital Clínico de la Pontificia Universidad Católica de Chile
Santiago de Chile, Chile, 8330024
Hospital Dr. Hernán Henriquez Aravena
Temuco, Chile
Hospital Dr. Gustavo Fricke
Viña del Mar, Chile
Italy
Azienda Ospedaliera Padova
Padova, Veneto, Italy, 35128
Peru
Instituto Nacional Materno Perinatal (INMP) de Perú
Lima, Peru
Sponsors and Collaborators
Edgardo Szyld
University of Alabama at Birmingham
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edgardo Szyld, Principal Investigator, Fundacion para la Salud Materno Infantil
ClinicalTrials.gov Identifier: NCT00443118    
Obsolete Identifiers: NCT01126489
Other Study ID Numbers: Fundasamin 102
First Posted: March 5, 2007    Key Record Dates
Results First Posted: March 31, 2015
Last Update Posted: September 28, 2018
Last Verified: August 2018
Keywords provided by Edgardo Szyld, Fundacion para la Salud Materno Infantil:
Bag and mask
Neopuff
Resuscitation
Newborn
Intubation
devices
PEEP