ResuscitationPhase 3NCT00443118
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
A Phase 3 study testing T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP and Self Inflating Bag without PEEP in people with Resuscitation, run by Edgardo Szyld at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 minutes
- Conditions the study is for
- Resuscitation
- What is being tested?
- T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP and Self Inflating Bag without PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,032 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Dec 2009to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Argentina4 sites
Sanatorio de los Arcos
Ciudad de Buenos Aires, Buenos Aires, C1425FSD
Hospital Misericordia
Córdoba
Hospital Universitario Austral
Pilar, Buenos Aires
Nuevo Hospital El Milagro de Salta
Salta, 4400
Chile3 sites
Hospital Clínico de la Pontificia Universidad Católica de Chile
Santiago, 8330024
Hospital Dr. Hernán Henriquez Aravena
Temuco
Hospital Dr. Gustavo Fricke
Viña del Mar
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Carol Jo Vecchie Women and Children's Center at St. John's Hospital
Springfield, Illinois, 19676
About this study
Official title: NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Resuscitation
- Being tested
- T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP, Self Inflating Bag without PEEP
- Keywords
- Bag and mask, Neopuff, Resuscitation, Newborn, Intubation, devices, PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-piece resuscitator Neopuff TMDevice
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 PEEPDevice
Also called Ambu
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 PEEPDevice
Also called Ambu
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.
| Study group | Role | What they receive |
|---|---|---|
| Neopuff TM with PEEP | Active comparator | Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP Receives: 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 Receives: 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 Receives: Device: Self Inflating Bag without PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
Measured: 2 minutes of life
Secondary outcomes (13)
Time the Newborn Takes to Reach a HR > 100 Bpm
Measured: 2 minutes of life
• SpO2 Value at 2 Minutes of Life.
Measured: 2 minutes of life
• Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.
Measured: after 2 minutes of life
• Need for Chest Compression and/or Medications
Measured: after 2 minutes of life
Apgar Scores at 1 and 5 Minutes
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.
Measured: 1-5 minutes of life
• Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)
Measured: first week of life
• Incidence of Air Leaks
included pneumothorax and Pneumomediastinum
Measured: after birth and during hospitalization up to four weeks
• Use of Oxygen Treatment Beyond the Delivery Room
Measured: during hospitalization
Days on Oxygen
Measured: after birth and during hospitalization up to four weeks
• Need for Mechanical Ventilation or CPAP
Measured: during hospitalization
Days on Mechanical Ventilation
Measured: after delivery and before four weeks
Days on CPAP
Measured: after birth and during hospitalization up to four weeks
• Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks
Incidence of intracranial hemorrhage grades 3-4 for preterm newborns <32 weeks by ultrasound evaluation
Measured: 1 day of life and 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startDec 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgardo Szyld
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor-investigator, Edgardo Szyld, Fundacion para la Salud Materno Infantil
- Investigators
- Edgardo Szyld, MD, Principal investigator, FundasaminAdriana Aguilar, MD, Study director, Hospital ParoissienWaldemar Carlo, MD, Study chair, University of Alabama at BirminghamNestor Vain, MD, Study director, Sanatorio de la TrinidadLuis Prudent, MD, Study director, Sanatorio Otamendi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443118
- Sponsor's protocol ID
- Fundasamin 102
- Status last verified
- Aug 2018
- First submitted
- 2 Mar 2007
- Last updated
- 28 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24690329
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00443118
- Acronym / sponsor ID
- Fundasamin 102
- Conditions
- Resuscitation
- Keywords
- Bag and mask, Neopuff, Resuscitation, Newborn, Intubation, devices, PEEP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,032 participants (actual)
- Lead sponsor
- Edgardo SzyldUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Mar 2007 (estimated)
- Results
- Posted 31 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neopuff TM with PEEP | Active comparator | Device: T-piece resuscitator Neopuff TMNewborns ventilated for neonatal resuscitation using Neopuff TM with PEEP |
| Self Inflating Bag with PEEP | Active comparator | Device: Self Inflating Bag with PEEPNewborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached |
| Self Inflating Bag without PEEP | Active comparator | Device: Self Inflating Bag without PEEPNewborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached |
Who may qualify
- Ages
- Up to 2 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-piece resuscitator Neopuff TMPositive 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. | Device | Neopuff TM with PEEP |
| Self Inflating Bag with PEEPAlso: AmbuPositive 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. | Device | Self Inflating Bag with PEEP |
| Self Inflating Bag without PEEPAlso: AmbuPositive 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. | Device | Self Inflating Bag without PEEP |
Primary outcome
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
Time frame: 2 minutes of life
13 secondary outcomes
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
• 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
• 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24690329Szyld 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.
- this paper was published on The Journal of PediatricsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgardo Szyld, MD principal investigator
Fundasamin
Adriana Aguilar, MD study director
Hospital Paroissien
Waldemar Carlo, MD study chair
University of Alabama at Birmingham
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP and Self Inflating Bag without PEEP in people with Resuscitation, run by Edgardo Szyld at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Argentina, Chile, United States, Italy, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. (time frame: 2 minutes of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00443118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.