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. 2020 Jul 1;2020(7):CD012011. doi: 10.1002/14651858.CD012011.pub2

Babaei 2013.

Study characteristics
Methods Randomised controlled trial
Participants Eligibility:
All term infants admitted to Imam Reza Hospital, Iran, for phototherapy, from October 2009 to September 2010 (decision to start phototherapy based on 2004 AAP neonatal jaundice guidelines)
Inclusion criteria:
1. Full term (completed 37 weeks) and birth weight ≥ 2500 grams
2. Serum bilirubin between 18 and 21 mg/dL at start of phototherapy (306 to 357 μmol/L)
Exclusion criteria:

  1. Major congenital anomalies

  2. Haemolytic disease

  3. Use of phenobarbital

  4. Use of herbal medication (Alhagi pseudalhagi, Fumaria parviflora, Ziziphus jujuba, purgative manna, Cichorium intybus)

  5. Elevated direct bilirubin > 20% of total bilirubin

  6. Symptoms of infection

  7. Postnatal age < 48 hours

  8. Postnatal age > 2 weeks at phototherapy initiation


Mean (SD) age in days at recruitment:
Intervention = 5.8 (1.9)
Control = 6.2 (2.1)
Mean (SD) body weight in kg of participants:
Intervention = 3.05 (0.35)
Control = 3.08 (0.34)
Interventions Intervention:
Standard phototherapy with white plastic cover around phototherapy unit (91 babies)
Plastic cover made of white shiny plastic; thickness 2 mm, length 66 cm, width 36 cm, height 45 cm, covering 3 sides of the phototherapy unit. From the photo attached in the article, it looked like a curtain hanging at the side of the phototherapy unit. One short side uncovered for observation. Distance from lamp to patient 40 cm
Control: (91 babies)
Standard phototherapy
Phototherapy lamp placed 40 cm above patient
Phototherapy unit used same brand with 6 blue lights
All units used in the study serviced before the study
Outcomes Total serum bilirubin levels on admission, after 12 and after 24 hours of phototherapy
Total duration of phototherapy and duration of hospital stay
Side effects of phototherapy (reported were rashes, dehydration, and hyperthermia)
Notes Photo irradiance not checked
Study performed in Imam Reza Hospital, Kermanshah Province of Iran, from October 2009 until September 2010
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation method not reported in the manuscript
Allocation concealment (selection bias) Low risk Sealed and opaque envelopes used (not reported whether they were sequentially numbered)
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants: neonates by definition blinded, but parents not blinded. Clinicians/Nurses not blinded. The type of intervention may have influenced handling of the baby by parents and healthcare providers
Blinding of outcome assessment (detection bias)
All outcomes Unclear 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 Intervention group: 1 dropout
Control group: 2 dropouts
Total dropout rate: low (1.6%)
Use of intention‐to‐treat analysis not reported
Selective reporting (reporting bias) Low risk No protocol available. All expected outcomes and all outcomes in the methods section reported
Other bias Low risk No other sources of bias identified