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| Name | Class |
|---|---|
| Royal Alexandra Hospital | OTHER |
| Foothills Medical Centre | OTHER |
| McMaster Children's Hospital | OTHER |
| St. Justine's Hospital |
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Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (T-Piece Resuscitator) | Active Comparator | Positive pressure ventilation during the first 10 minutes after birth will be provided with a T-Piece Resuscitator (TPR; Neopuff, Fisher & Paykel Healthcare) connected to an appropriately sized face-mask, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. |
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| Intervention under investigation (Ventilator delivered PPV) | Experimental | Positive pressure ventilation (PPV) during the first 10 minutes after birth will be provided using a neonatal ventilator set up in noninvasive positive pressure ventilation (NIPPV) mode, connected to an appropriately sized nasal mask or prongs and a dual limb neonatal ventilator circuit, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, respiratory rate and inspiratory time and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilator derived positive pressure ventilation - V-PPV | Device | The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pre-discharge mortality | Death in NICU | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Major neuro-injury | Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia. | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Moderate-severe BPD | Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation. | At 36 weeks' postmenstrual age. |
| Measure | Description | Time Frame |
|---|---|---|
| Components of the primary outcome | Pre-discharge mortality, major neuro-injury or moderate-severe BPD | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Frequency of receipt of advanced cardiopulmonary resuscitation measures |
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Inclusion Criteria::
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thaiani Wulff, BSc | Contact | 1-416-586-4800. | 176746 | thaiani.wulff@sinaihealth.ca |
| Laura Thomas, MSc | Contact | 416-586-4800 | 172060 | laura.thomas@sinaihealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Baczynski, MSc | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Guerin Children's | Recruiting | Los Angeles | California | 90505 | United States |
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| OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Montreal Children's Hospital of the MUHC | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| London Health Sciences Centre | OTHER |
| BC Women's Hospital & Health Centre | OTHER |
This study will be a cluster-crossover, unmasked randomized control trial (RCT) comparing the clinical effectiveness of two existing methods for providing PPV to preterm neonates born 25+0 to 28+6 weeks gestational age during initial resuscitation after birth.
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The DSMB will assess intervention compliance and mortality rates, masked to the group allocation. The trial statistician will be blinded to group allocations.
|
| T-piece resuscitator (TPR) | Device | The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher & Paykel Healthcare) connected to an appropriately sized face-mask. |
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Chest compressions or epinephrine administration for the purpose of resuscitation. |
| From enrollment to 1 hour post intervention. |
| Duration of invasive mechanical ventilation during NICU admission | Total number of days on invasive mechanical ventilation | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Discharge on home oxygen | Discharge from the NICU requiring oxygen support at home | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Other relevant key prematurity related adverse outcome | Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment. | From enrollment through study completion (up to 50 weeks postmenstrual age) |
| Foothills Medical Centre | Recruiting | Calgary | Alberta | Canada |
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| Royal Alexandra Hospital | Recruiting | Edmonton | Alberta | Canada |
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| BC Children's and Women's Hospital | Not yet recruiting | Vancouver | British Columbia | Canada |
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| McMaster Children's Hospital | Recruiting | Hamilton | Ontario | Canada |
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| Children's Hospital at London Health Sciences Centre | Not yet recruiting | London | Ontario | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| Montreal Children's Hospital | Recruiting | Montral | Quebec | Canada |
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| CHU Sainte Justine | Recruiting | Montreal | Quebec | Canada |
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| Rigshospitalet Coppenhagen | Not yet recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D055370 | Lung Injury |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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