Nakamura 2016.
Methods | Randomised double‐blind placebo controlled trial Blinding of randomisation: yes Blinding of intervention: yes Complete follow‐up: yes Blinding of outcome measurement: yes for all outcomes except for neuromotor examination |
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Participants | Infants (n = 211) with birth weight < 1000 grams who needed endotracheal intubation and respiratory support due to respiratory failure. Demographic data: values are presented as mean (SD) or mean (range) or percentage Fluticasone propionate group: n = 107 Birthweight (g): 784 (135) Gestational age (weeks): 26.1 (25.1 to 27.3) Sex (% male): 58.9 Placebo group: n = 104 Birth weight (g): 784 (127) Gestational age (weeks): 26.2 (25.1 to 27.3) Sex (% male): 48.1 |
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Interventions | Prophylactic inhaled steroids starting within 24 h of birth and continuing until 6 weeks of age or extubation. Two doses of 50 µg fluticasone propionate (FP) were administered every 24 h (n = 107). The placebo contained only hydrofluoroalkane propellant (n = 104). | |
Outcomes | The primary outcome measure used to indicate the morbidity of severe BPD was death or oxygen dependence at discharge. The secondary outcomes were death, severe BPD and neurodevelopmental outcomes at 18 months' PMA and 3 years of age | |
Notes | Because of financial constraints the study was stopped early. The authors reported all outcomes as a combination of death and a clinical complication of preterm birth. We wrote to the first author on 20 May 2016, for clarifications regarding outcomes, but as of 20th July 2016 we have not received a response. We chose to report the data as per the authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | An independent Internet‐based patient registration and randomisation robot. Central randomisation. |
Allocation concealment (selection bias) | Low risk | Fluticasone propionate (FP) and placebo metered‐dose inhalers providing 50 g per actuation were obtained from the drug manufacturer. Fluticasone propionate and placebo were delivered from the metered‐dose inhaler with a valve space chamber interposed between the neonatal anaesthesia bag and the endotracheal tube. Double‐blind placebo‐controlled trial. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Staff was blinded to FP and placebo. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcomes were assessed blinded to the groups except for the neuromotor exams. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All infants enrolled are accounted for. |
Selective reporting (reporting bias) | Unclear risk | The protocol for the study was not available to us so we cannot ascertain if there were any deviations from the protocol. Because of financial constraints the study was stopped early. |
Other bias | Low risk | Appears free of other bias. |