ISRCTN38965585.

Methods	Single‐centre cluster‐randomised controlled trial
Participants	Aim: 41,072 newborns from 276 clusters
Interventions	Intervention: Product: cold‐pressed sunflower seed oil The directions for newborn massage further consist of the following aspects. Dosage of sunflower seed oil, comprising frequency of use, quantity per use, and duration of use: Dose: 10 g per application, applied 3x daily Duration: 0 to 27 days of life Improvements in overall massage practice: Encourage handwashing before massage Encourage gently massaging the vernix into the newborn skin, rather than forcefully removing it Promote gentle massage of newborns Delay use of mustard oil and skin‐scrubbing substances such as bukwa (coarse‐grained paste made of mustard/wheat seeds along with additives) past the newborn period Ensure that the newborn is kept warm during and after massage Comparator: control group, which will continue following the same traditional massage practices, including the type of oil used. No further information provided.
Outcomes	Primary outcome: infant mortality rate. SCiPAD outcome of interest in this study is: 1. Infections and hospitalisation: signs and symptoms of infection during the newborn period, along with episodes of hospitalisation, would be recorded through parent recall. These will include local infections such as pyoderma and umbilical cord infection. Skin barrier function: barrier property of stratum corneum (assessed as TEWL) Adherence to intervention: information on continued oil use and adherence to massage technique would be obtained from families (mothers). This would also be applicable to a subsample (5%) of the population.
Notes	No response from study author, emailed on 14 January 2020.  No response from study author when emailed for update or when emailed through dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/TGNC9H. Link to trial: www.isrctn.com/ISRCTN38965585