Nasal vs face mask Continuous Positive Airway Pressure (CPAP) for neonatal resuscitation

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2020
INTERVENTION: In the intervention arm initial respiratory support immediately after birth is provided using a nasal mask for CPAP and supplemental oxygen. In the control arm initial respiratory support is provided using a face mask. The duration of this support is between the time of birth and transfer to the NICU, about 10‐20 minutes. The treatment will be administered by the neonatal team, typically the neonatal registrar, fellow, nurse practitioner, or consultant, depending on the composition of the team at birth. Note, all infants born at less than 27 weeks and all twins born at less than 29 weeks will have a consultant present at the birth. Our primary outcome is the proportion of infants that are managed with CPAP only in the nasal CPAP versus face mask CPAP groups. Failure of CPAP only treatment means that the infant received positive pressure ventilation via a facemask or an endotracheal tube. Success of the intervention will be recorded in the existing medical records. CONDITION: Premature birth at less than 32 weeks gestational age;Neonatal resuscitation;Respiratory distress syndrome; ; Premature birth at less than 32 weeks gestational age ; Neonatal resuscitation ; Respiratory distress syndrome Reproductive Health and Childbirth ‐ Childbirth and postnatal care Reproductive Health and Childbirth ‐ Complications of newborn Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: The primary outcome is the proportion of infants that are managed with CPAP only in the nasal CPAP vs face mask CPAP groups immediately after birth. ; ; The success of the intervention is recorded in the existing medical records.[Prior to transport to the NICU, typically 10 minutes after birth. ] SECONDARY OUTCOME: Adverse events prior to hospital discharge: including pneumothorax, intraventricular haemorrhage, necrotising enterocolitis, sepsis, periventricular leukomalacia, retinopathy of prematurity requiring surgical intervention, and mortality. ; ; This information is recorded in the existing medical records.[Prior to hospital discharge. ; ; This information is recorded in the existing medical records.] Apgar scores at 1 and 5 minutes between groups. ; ; This information is recorded in the existing medical records.[At 1 and 5 minutes after birth. ] Corrected gestational age of the infant successfully weaning off any respiratory support (supplemental oxygen and/or CPAP/HiFlow) in each group. ; ; This information is recorded in the existing medical records.[Prior to hospital discharge. ; ; This information is recorded in the existing medical records.] Days of mechanical ventilation during hospital admission in each group. ; ; This information is recorded in the existing medical records.[From birth to hospital discharge. ] Maximum FiO2 provided during initial neonatal stabilisation. ; ; This information is recorded in the existing medical records.[Prior to transfer to the NICU, typically 10 minutes after birth. ] Maximum inflation pressure provided for initial neonatal stabilisation. ; ; This information is recorded in the existing medical records.[Prior to transfer to the NICU, typically 10 minutes after birth. ] Percent intubation and mechanical ventilation within the first 72 hours after birth in each group. ; ; This information is recorded in the existing medical records.[Within 72 hours of birth.] Percent of infants in each group that are intubated prior to transfer to the NICU. ; ; ; ; This information is recorded in the existing medical records.[From birth until hospital discharge. ] INCLUSION CRITERIA: Inborn infants 23 0/7 to 31 6/7 weeks gestation born at MMC Clayton are eligible for this study. ; The success of the intervention is recorded in the existing medical records.[Prior to transfer to the NICU, typically 10 minutes after birth. ] Percent of infants receiving surfactant and method of administration in each group. ; This information is recorded in the existing medical records.[Within 72 hours of birth.] Rates of chronic lung disease (need for respiratory support or oxygen at 36 weeks corrected gestational age) in each group.
Epistemonikos ID: e53afcf1d8be3a465f5f3d13067f666b1889f5cd
First added on: Aug 24, 2024