Asadollahpour 2015.
Methods | Country: Iran RCT Three study groups. Randomisation method not fully described No evidence of allocation concealment Blinding of personnel delivering the intervention unclear Blinding of outcome assessor unclear |
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Participants | Preterm infants from 26 to 32 weeks of gestational age fed through a tube with birth weight 1000 to 2000 grams NNS intervention group: N = 11 (6 male/5 female), GA 30.18 ± 1.77 weeks, birth weight 1406.36 grams Prefeeding oral stimulation group: N = 10 (5 male/5 female), GA 30.01 ± 1.76, birth weight 1343.01 grams Control group: N = 11 (5 male/6 female), GA 30.29±1.95, birth weight 1393.63 grams |
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Interventions |
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Outcomes |
Primary outcome: time to attain independent oral feeding Secondary outcomes:
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Notes | For birth weight, median values provided. Mean or standard deviation had to be calculated. Adverse events not recorded or reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random assignment was performed by 'a simple randomisation method', whereby infants were randomly assigned to NNS (n = 11), prefeeding oral stimulation (n = 10) and control (n = 11) groups. This was not clearly described. |
Allocation concealment (selection bias) | High risk | Despite study authors reporting, "This intervention delivered by one speech therapist who was blinding to research", this SLT delivered all interventions and therefore was aware of allocation in all groups. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Same SLT delivered all interventions and sham interventions and was not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Weight was measured by 'a nurse'. It is unclear whether the same nurse measured all infants, or whether the nurse on duty at the time of weigh in performed the measurements. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes are reported. No data were missing. |
Selective reporting (reporting bias) | Low risk | All of the study’s prespecified outcomes and all expected outcomes of interest to the review were reported. |
Other bias | Unclear risk | Information was insufficient to permit judgement. Adverse events were not recorded or reported. |