Darmstadt 2004.
| Methods | Randomised controlled trial. | |
| Participants | Preterm infants of gestational age < 34 weeks and postnatal age < 72 hours. Exclusions: Infants considered likely to die within 48 hours, infants with major congenital anomalies, infants requiring major surgery, infants with immunodeficiency. |
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| Interventions | 1. Cutaneous application of sunflower seed oil to whole body apart from face and head (4 grams/kg/dose): N = 51. Infants received emollient thrice daily for 14 days, then twice daily until 28 days or discharge from hospital. 2. No emollient: N = 52. Control infants received standard skin care for preterm infants, which included minimal to no use of topical emollients. |
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| Outcomes | Mortality attributed to sepsis (all‐cause mortality not reported or available from investigators). Invasive infection diagnosed more than 2 days after birth: The report did not state the number of infants in each group who had (at least one) episode of invasive infection. We contacted the principal investigator to seek these data but these have not yet been provided. |
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| Notes | Setting: Kasr El‐Aini NICU, Cairo University (dates not stated but trial likely to have been undertaken during late 1990s or early 2000s). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | High risk | Unblinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete outcome assessment |