Nopper 1996.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Preterm infants (gestational age < 33 weeks), aged < 96 hours, without evidence of skin disease. | |
Interventions | 1. Prophylactic application of preservative‐free ointment (Aquaphor, Beiersdorf, Inc.) applied twice daily: N = 30
2. Standard skin care (which could include a water‐in‐oil emollient if required (Eucerin, Beiersdorf, Inc.): N = 30 Intervention applied for 14 days. |
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Outcomes | Invasive infection. Mortality. Weight change. Time to regain birth weight. |
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Notes | Setting: Departments of Dermatology and Pediatrics, Stanford University, California, early‐mid 1990s (single centre). Clarification of methods and outcomes courtesy of Professor Alfred Lane (May 2014). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unmasked parents and caregivers |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unmasked clinicians and investigators |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete follow‐up |
Selective reporting (reporting bias) | Low risk | Unlikely |
Other bias | Low risk | No evidence of baseline imbalance |