Osman 2019.
| Methods | This a randomized controlled trial to assess efficacy of early CPAP, in reducing the severity and duration of TTN compared with administration of free‐flow oxygen. | |
| Participants | 64 late preterm/term neonates, delivered by cesarean section and presenting with respiratory distress shortly after birth. | |
| Interventions | Patients were randomized to receive 20 m of early CPAP, delivered using a T‐piece‐based infant resuscitator (Neopuff) via a face mask, or to receive free‐flow oxygen. | |
| Outcomes | Primary outcome measures include assessment of the duration and degree of respiratory distress. Secondary outcome measures include the need for admission to NICU secondary to respiratory distress of more than 6 h, plasma BNP post‐Neopuff levels, the need of mechanical ventilation, the incidence of pulmonary air leaks, the duration of hospitalization and mortality. |
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| Notes | clinicaltrials.gov/ct2/show/nct01859533 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The newborns were randomly assigned into 2 groups using computer‐generated randomization. |
| Allocation concealment (selection bias) | Unclear risk | No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | The assigned intervention could not be blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data were reported. |
| Selective reporting (reporting bias) | High risk | 1 of the secondary outcomes became primary outcome and there is no information on 2 secondary outcomes. |
| Other bias | Low risk | Appears free of other bias. |
CPAP = continuous positive airway pressure g = grams GA = gestational age m = minutes NCPAP = nasal continuous positive airway pressure NHFPV = nasal high frequency percussive ventilation NIMV = nasal intermittent mandatory ventilation NICU = neonatal intensive care unit TTN = transient tachypnea of the newborn