Methods
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Randomized placebo controlled two by two factorial trial conducted in Guinea‐Bissau |
Participants
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Inclusion criteria: Weight <2500 g at presentation |
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Exclusion criteria: Weight >2500 g at presentation |
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Total number randomized to the intervention group: 864 |
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Total number randomized to the control group: 872 |
Interventions
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Intervention: 25,000 IU vitamin A intradermally |
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Control: 0.5 ml vegetable oil intradermally |
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Common intervention given to all groups: 10 IU vitamin E intradermally |
Outcomes
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Primary outcomes: Infant mortality |
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Other outcomes: Fever, septicaemia, malaria, malnutrition, and respiratory infections |
Notes
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