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. 2023 Apr 11;2023(4):CD013873. doi: 10.1002/14651858.CD013873.pub2

Zhao 2016.

Study characteristics
Methods Study design: double‐blind RCT
Location: China
Setting: one neonatal unit (Tianjin Central Hospital of Gynaecology Obstetrics)
Duration: October 2013 to December 2014
Participants Inclusion criteria: 164 infants < 32 weeks' gestational age who were diagnosed with apnea
Exclusion criteria: infants with congenital malformations and chromosomal abnormalities, central nervous system diseases, primary lung diseases, serious infection, metabolic diseases, obstructive apnea etc.
Interventions High dose: loading dose 20 mg/kg/day and maintenance dose 15 mg/kg/day
Low dose: loading dose 20 mg/kg/day and maintenance dose 5 mg/kg/day
Outcomes Outcomes reported that are considered for this review:

  • mortality during first admission;

  • chronic lung disease at 36 weeks of corrected age;

  • apnea;

  • success in ventilator removal;

  • any tachycardia.
Notes Baseline imbalances: none
No trial protocol available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were allocated into low‐dose or high‐dose group using a random number table by a researcher who did not participate in data collection or analysis.
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias)
All outcomes Low risk Researchers, nurses, and family members did not know about the grouping arrangement.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Described, but not for all outcomes.
Incomplete outcome data (attrition bias)
All outcomes Low risk All patients were analyzed for the outcomes.
Selective reporting (reporting bias) Unclear risk Trial protocol not available.
Other bias Low risk None known

BPD: bronchopulmonary dysplasia; CPAP: continuous positive airway pressure; FiO2: fraction of inspired oxygen; ITT: intention‐to‐treat; kg: kilogram; mg: milligram; MRI: magnetic resonance imaging; MV: mechanical ventilation; NICU: neonatal intensive care unit; PDA: patent ductus arteriosus; RCT: randomized controlled trial; SD: standard deviation; US: ultrasound