Infant, Premature, Diseases Clinical Trial
— ROSAOfficial title:
A Randomised Trial of Routine or Selective Application of a Face Mask for Preterm Infants at Birth
NCT number | NCT04500353 |
Other study ID # | ROSA.01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 11, 2020 |
Est. completion date | May 9, 2023 |
Verified date | December 2023 |
Source | University College Dublin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
International guidelines recommend giving positive pressure ventilation (PPV) by face mask to newborns who do not breathe or have a slow heart rate at birth. Preterm infants are at high risk of developing respiratory distress syndrome (RDS) and many are treated with continuous positive airway pressure (CPAP) in the neonatal intensive care unit (NICU). Though the majority of preterm infants breathe spontaneously at birth, many clinicians routinely apply a face mask to preterm infants shortly after birth in the delivery room (DR) to give them CPAP. However, applying a face mask may inhibit spontaneous breathing in newborns. In this study, premature babies will be randomly assigned to have a face mask routinely applied for CPAP shortly after birth; or to have a face mask selectively applied only for PPV if they are not breathing or have a slow heart beat in the first 5 minutes of life, or for CPAP if they have signs of respiratory distress after 5 minutes. The investigators will determine whether fewer participants who have the mask selectively applied receive PPV in the DR.
Status | Completed |
Enrollment | 201 |
Est. completion date | May 9, 2023 |
Est. primary completion date | February 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Minutes to 5 Minutes |
Eligibility | Inclusion Criteria: - Born before 32 weeks gestational age by best obstetric estimate Exclusion Criteria: - Infants with major congenital anomalies |
Country | Name | City | State |
---|---|---|---|
Ireland | National Maternity Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
University College Dublin |
Ireland,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of participants who receive face mask PPV in the delivery room DR | The proportion of participants who receive face mask positive pressure ventilation (PPV) in the delivery room (DR) | Within 30 minutes of birth | |
Secondary | The proportion of participants who receive face mask CPAP in the first 5 minutes of life | The proportion of participants who receive face mask (continuous positive airway pressure) CPAP in the first 5 minutes of life | 5 minutes | |
Secondary | The proportion of participants who receive face mask PPV in the first 5 minutes of life | The proportion of participants who receive face mask PPV in the first 5 minutes of life | 5 minutes | |
Secondary | HR at 5 minutes of life | Heart rate (HR) at 5 minutes of life | 5 minutes | |
Secondary | SpO2 at 5 minutes of life | Oxygen saturation (SpO2) at 5 minutes of life | 5 minutes | |
Secondary | The proportion of participants who receive face mask CPAP in the DR | The proportion of participants who receive face mask CPAP in the DR | Within 30 minutes of birth | |
Secondary | Duration of PPV in the DR | Duration of PPV in the DR | Within 30 minutes of birth | |
Secondary | The proportion of participants who are intubated in the DR | The proportion of participants who are intubated in the DR | Within 30 minutes of birth | |
Secondary | The proportion of participants who receive chest compressions in the DR | The proportion of participants who receive chest compressions in the DR | Within 30 minutes of birth | |
Secondary | The proportion of participants who receive volume in the DR | The proportion of participants who receive volume in the DR | Within 30 minutes of birth | |
Secondary | The proportion of participants who receive adrenaline in the DR | The proportion of participants who receive adrenaline in the DR | Within 30 minutes of birth | |
Secondary | Maximum FiO2 in the DR | Maximum fraction of inspired oxygen (FiO2) in the DR | Within 20 minutes of birth | |
Secondary | Apgar score at 5 minutes | Apgar score at 5 minutes (scale 0 -10, higher scores indicate better outcome) | 5 minutes | |
Secondary | Apgar score at 10 minutes | Apgar score at 10 minutes (scale 0 -10, higher scores indicate better outcome) | 10 minutes | |
Secondary | Respiratory support in transport to NICU | Respiratory support in transport to the neonatal intensive care unit (NICU) | Within 45 minutes of birth | |
Secondary | The proportion of participants who receive NCPAP in NICU | The proportion of participants who receive nasal CPAP in NICU | Within one month | |
Secondary | The proportion of participants who receive endotracheal ventilation in NICU | The proportion of participants who receive endotracheal ventilation in NICU | Within one month | |
Secondary | The proportion of participants who receive surfactant treatment | The proportion of participants who receive surfactant treatment | Within one month | |
Secondary | The proportion of participants who have a pneumothorax drained | The proportion of participants who have a pneumothorax drained | Within one month | |
Secondary | The proportion of participants who survive free of BPD | The proportion of participants who are alive and not receiving respiratory support or supplemental oxygen on day 28 of life | Day 28 of life | |
Secondary | The proportion of participants who receive survive free of CLD | The proportion of participants who are alive and not receiving respiratory support or supplemental oxygen at 36 weeks corrected age | 36 weeks corrected | |
Secondary | The proportion of participants who receive postnatal steroids | The proportion of participants who receive postnatal steroids | Through study completion, an average of 2-3 months in survivors | |
Secondary | The proportion of participants who receive home oxygen therapy | The proportion of participants who receive home oxygen therapy | Through study completion, an average of 2-3 months in survivors | |
Secondary | The proportion of participants who die before hospital discharge | The proportion of participants who die before hospital discharge | Through study completion, an average of 2-3 months in survivors |
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