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 |
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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 |
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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 |
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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. |