Apnea Neonatal, Neonatal Resuscitation
Conditions
Keywords
Premature Infant, Preterm Neonates, Oxygen, Lung Injury, Respiration, Artificial, Resuscitation, Ventilator, Mechanical
Brief summary
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.
Interventions
DEVICEVentilator derived positive pressure ventilation - V-PPV
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.
DEVICET-piece resuscitator (TPR)
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.
Sponsors
Michelle Baczynski
Royal Alexandra Hospital
Foothills Medical Centre
McMaster Children's Hospital
St. Justine's Hospital
Cedars-Sinai Medical Center
Montreal Children's Hospital of the MUHC
Sunnybrook Health Sciences Centre
London Health Sciences Centre
BC Women's Hospital & Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The DSMB will assess intervention compliance and mortality rates, masked to the group allocation. The trial statistician will be blinded to group allocations.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
: * GA 25+0 to 28+6 weeks using the best available obstetrical estimate * Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care * Received PPV as determined by the resuscitation team during the first 10 minutes of birth
Exclusion criteria
* Outborn birth status * Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward) * Known major congenital or chromosomal anomaly * Established spontaneous respiration without receipt of PPV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of pre-discharge mortality | From enrollment through study completion (up to 50 weeks postmenstrual age) | Death in NICU |
| Major neuro-injury | From enrollment through study completion (up to 50 weeks postmenstrual age) | Defined as IVH ≥grade 3, cerebellar hemorrhage or periventricular leukomalacia. |
| Moderate-severe BPD | At 36 weeks' postmenstrual age. | Defined as 2 L/min nasal cannula or other forms of non-invasive ventilation support or invasive mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Components of the primary outcome | From enrollment through study completion (up to 50 weeks postmenstrual age) | Pre-discharge mortality, major neuro-injury or moderate-severe BPD |
| Frequency of receipt of advanced cardiopulmonary resuscitation measures | From enrollment to 1 hour post intervention. | Chest compressions or epinephrine administration for the purpose of resuscitation. |
| Duration of invasive mechanical ventilation during NICU admission | From enrollment through study completion (up to 50 weeks postmenstrual age) | Total number of days on invasive mechanical ventilation |
| Discharge on home oxygen | From enrollment through study completion (up to 50 weeks postmenstrual age) | Discharge from the NICU requiring oxygen support at home |
| Other relevant key prematurity related adverse outcome | From enrollment through study completion (up to 50 weeks postmenstrual age) | Necrotizing enterocolitis ≥ stage 2a, retinopathy of prematurity needing treatment. |
Countries
Canada, Denmark, United States
Contacts
CONTACTThaiani Wulff, BSc
CONTACTLaura Thomas, MSc
PRINCIPAL_INVESTIGATORMichelle Baczynski, MSc
MOUNT SINAI HOSPITAL
Outcome results
None listed