Darmstadt 2005.

Methods	Randomised controlled trial.
Participants	Preterm infants of gestational age at birth < 33 weeks and aged < 72 hours. Exclusions: Infants considered likely to die within 48 hours, infants with major congenital anomalies, infants requiring major surgery, infants with established skin infections.
Interventions	Cutaneous massage (whole body apart from face and head) with: 1. Sunflower seed oil: N = 159 2. Aquaphor®: N = 157 3. No emollient (control): N = 181 Infants were massaged thrice daily for 14 days, then twice daily until discharge from hospital. Control infants received standard skin care for preterm infants, which included minimal to no use of topical emollients.
Outcomes	Invasive infection. Mortality.
Notes	Setting: Special Care Nursery, Dhaka Shishu Hospital, Bangladesh (1998 to 2003). Aquaphor is a water‐free petrolatum‐based ointment manufactured by Beiersdorf. The report states that infants were randomised within "blocks of six with two assignments per block for all three of the groups". However, this process appears to be inconsistent with the allocated distribution of infants: 1. sunflower seed oil (N = 159), or 2. Aquaphor (N = 157), or 3. no emollient (control) (N = 181). The principal investigator of the trial has explained that this inconsistency may be due to two possible factors: 1. The trial originally had a fourth arm (emollient therapy with safflower oil) which was deemed unacceptable to parents and caregivers and removed from the trial when 24 infants had been randomised to the arms. These infants were not included in the final analyses. 2. The allocation sequence generation method was changed from the original manual process (selecting from a block of six envelopes) to a computer‐generated sequence that did not maintain the balance of assignments within blocks.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Manual generation of blocks of six with two assignments per block for all three of the groups, then computer‐generated sequence
Allocation concealment (selection bias)	Low risk	Sealed opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Unblinded parents, caregivers, clinicians and investigators
Incomplete outcome data (attrition bias) All outcomes	Low risk	Near‐complete follow‐up assessment