Rashmi 2015.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Inclusion criteria:
Exclusion criteria:
Mean (SD) age in days at recruitment: Intervention = 4.47 (1.4) Control = 3.80 (1.26) Mean (SD) body weight in kg of participants: Intervention = 2.19 (0.31) Control = 2.23 (0.43) |
|
Interventions |
Intervention: standard phototherapy with white reflective curtains around the phototherapy unit (15 infants) Control: standard phototherapy without reflective curtains (15 infants) |
|
Outcomes | Mean SB at 24 and 48 hours Mean duration of phototherapy in hours |
|
Notes | Nature of reflective material used not reported. Study conducted in Uttarakhand, India. Only one outcome reported. Data on adverse effects (skin turgor, skin rash, loose stools, body temperature, pulse respiration, blood pressure) collected but not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Newborns were randomly assigned into experimental and control groups" ‐ exact method of random sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not described Comment: we judged that blinding of parents and caregivers would not be possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported. We judged bilirubin measurement to be an objective measurement not affected by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 30 patients randomly assigned to 2 groups. Results tables provide data for 30 neonates (15 per group). We judged no loss to follow‐up |
Selective reporting (reporting bias) | High risk | Adverse effects monitored but not reported |
Other bias | Unclear risk | None detected |