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

NCT00443118 | Completed Phase 3 Results DMC

• 1 other identifier: Fundasamin 102
• Study Type: interventional
• Target: 1,032
• Locations: 5 countries
• Sites: 11

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.

Conditions

Resuscitation

Keywords

Bag and mask; Neopuff; Resuscitation; Newborn; Intubation; devices; PEEP

Outcome Measures

Primary Outcomes (1)

• Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.

  2 minutes of life

Secondary Outcomes (13)

• Time the Newborn Takes to Reach a HR > 100 Bpm

  2 minutes of life

• • SpO2 Value at 2 Minutes of Life.

  2 minutes of life

• • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.

  after 2 minutes of life

• • Need for Chest Compression and/or Medications

  after 2 minutes of life

• Apgar Scores at 1 and 5 Minutes

  1-5 minutes of life

Study Arms (3)

Neopuff TM with PEEP

ACTIVE COMPARATOR

Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP

Device: T-piece resuscitator Neopuff TM

Self Inflating Bag with PEEP

ACTIVE COMPARATOR

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

Device: Self Inflating Bag with PEEP

Self Inflating Bag without PEEP

ACTIVE COMPARATOR

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

Device: Self Inflating Bag without PEEP

Interventions

T-piece resuscitator Neopuff TM DEVICE

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.

Neopuff TM with PEEP

Self Inflating Bag with PEEP DEVICE

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.

Also known as: Ambu

Self Inflating Bag with PEEP

Self Inflating Bag without PEEP DEVICE

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.

Also known as: Ambu

Self Inflating Bag without PEEP

Eligibility Criteria

• Age: Up to 2 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgardo Szyld: lead
• University of Alabama at Birmingham: collaborator

Study Sites (11)

Carol Jo Vecchie Women and Children's Center at St. John's Hospital

Springfield, Illinois, 19676, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Sanatorio de los Arcos

Ciudad de Buenos Aires, Buenos Aires, C1425FSD, Argentina

Location

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Location

Hospital Misericordia

Córdoba, Argentina

Location

Nuevo Hospital El Milagro de Salta

Salta, 4400, Argentina

Location

Hospital Clínico de la Pontificia Universidad Católica de Chile

Santiago, 8330024, Chile

Location

Hospital Dr. Hernán Henriquez Aravena

Temuco, Chile

Location

Hospital Dr. Gustavo Fricke

Viña del Mar, Chile

Location

Azienda Ospedaliera Padova

Padua, Veneto, 35128, Italy

Location

Instituto Nacional Materno Perinatal (INMP) de Perú

Lima, Peru

Location

Related Publications (1)

• 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.

  PMID: 24690329 DERIVED

Related Links

• this paper was published on The Journal of Pediatrics

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Edgardo Szyld MD, MSc
• Organization: FUNDASAMIN-Fundacion para la Salud Materno Infantil

eszyld@gmail.com

5491144093095

Study Officials

• Edgardo Szyld, MD

  Fundasamin

  PRINCIPAL INVESTIGATOR

• Adriana Aguilar, MD

  Hospital Paroissien

  STUDY DIRECTOR

• Waldemar Carlo, MD

  University of Alabama at Birmingham

  STUDY CHAIR

• Nestor Vain, MD

  Sanatorio de la Trinidad

  STUDY DIRECTOR

• Luis Prudent, MD

  Sanatorio Otamendi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: December 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 28, 2018
• Results First Posted: March 31, 2015

Record last verified: 2018-08

Locations

US (2); IT (1); CL (3); AR (4); PE (1)