Clinical trial NCT00443118: Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Resuscitation
Keywords: Bag and mask
Neopuff
Resuscitation
Newborn
Intubation
devices
PEEP
Lead sponsor: Fundacion para la Salud Materno Infantil
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2007-03-05
Enrollment: 1032
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
timeFrame: 2 minutes of life
Secondary outcomes:
measure: Time the Newborn Takes to Reach a HR > 100 Bpm
timeFrame: 2 minutes of life
measure: • SpO2 Value at 2 Minutes of Life.
timeFrame: 2 minutes of life
measure: • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.
timeFrame: after 2 minutes of life
measure: • Need for Chest Compression and/or Medications
timeFrame: after 2 minutes of life
measure: Apgar Scores at 1 and 5 Minutes
timeFrame: 1-5 minutes of life
measure: • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)
timeFrame: first week of life
measure: • Incidence of Air Leaks
timeFrame: after birth and during hospitalization up to four weeks
measure: • Use of Oxygen Treatment Beyond the Delivery Room
timeFrame: during hospitalization
measure: Days on Oxygen
timeFrame: after birth and during hospitalization up to four weeks
measure: • Need for Mechanical Ventilation or CPAP
timeFrame: during hospitalization
measure: Days on Mechanical Ventilation
timeFrame: after delivery and before four weeks
measure: Days on CPAP
timeFrame: after birth and during hospitalization up to four weeks
measure: • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks
timeFrame: 1 day of life and 30 days after birth
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Carol Jo Vecchie Women and Children's Center at St. John's Hospital
state: Illinois
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Ciudad de Buenos Aires
country: Argentina
facility: Sanatorio de los Arcos
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Hospital Misericordia
city: Salta
country: Argentina
facility: Nuevo Hospital El Milagro de Salta
city: Santiago de Chile
country: Chile
facility: Hospital Clínico de la Pontificia Universidad Católica de Chile
city: Temuco
country: Chile
facility: Hospital Dr. Hernán Henriquez Aravena
city: Viña del Mar
country: Chile
facility: Hospital Dr. Gustavo Fricke
city: Padova
country: Italy
facility: Azienda Ospedaliera Padova
state: Veneto
city: Lima
country: Peru
facility: Instituto Nacional Materno Perinatal (INMP) de Perú
Study officials:
affiliation: Fundasamin
name: Edgardo Szyld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Paroissien
name: Adriana Aguilar, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Waldemar Carlo, MD
role: STUDY_CHAIR
affiliation: Sanatorio de la Trinidad
name: Nestor Vain, MD
role: STUDY_DIRECTOR
affiliation: Sanatorio Otamendi
name: Luis Prudent, MD
role: STUDY_DIRECTOR
References:
citation: 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.