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. 2017 Jan 23;2017(1):CD003059. doi: 10.1002/14651858.CD003059.pub3

Viscardi 1997.

Methods Randomised, prospective, double‐blind, placebo‐controlled trial
Blinding of randomisation: yes
Blinding of intervention: yes
Complete follow up: yes
Blinding of outcome: yes, CXRs were reviewed by a single observer blinded to the treatment regimens
Participants Number of infants entered into the study: 26
Mean BW (SD): 687 ± 46 g in the treatment group and 702 ± 35 g in the control group
Mean GA (SD): 24.6 ± 0.4 weeks in the treatment group and 25.1 ± 0.4 weeks in the control group
Age of enrolment into study: day 3
Other characteristics: high probability of oxygen dependence at 28 days predicted by a CLD score at 12 hours of age
Exclusion criteria: documented sepsis, congenital cardiopulmonary anomalies
Study location: University of Maryland Hospital
Study period: not stated
Interventions Nebulised cromolyn sodium 20 mg (n = 13) or 2 mL normal saline placebo (n = 13) every 6 hours from day 3 until day 28
Outcomes Primary outcomes: CLD at 28 days of life and at 36 weeks' postmenstrual age. Changes in inflammatory cell populations and the cytokines in lung lavage in response to cromolyn therapy
Secondary outcomes: number of ventilator days, duration of oxygen supplementation, PDA, air leak, sepsis, NEC and IVH
Notes 100% of the control group and 77% of cromolyn sodium‐treated infants received exogenous surfactant. No adverse effects that could be attributed to the administration of cromolyn sodium were noted.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was accomplished by a computer‐generated table of random numbers.
Allocation concealment (selection bias) Low risk Blinding of randomisation: yes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of intervention: yes (however, pharmacist aware of treatment assignment).
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk CXRs were reviewed by a single observer blinded to the treatment regimens.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Complete follow‐up: yes.
Selective reporting (reporting bias) Unclear risk The protocol for the study was not available to us so we could not judge if there were any deviations.
Other bias Low risk Appeared free of other bias.