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Preventing Infant Malnutrition with Early Supplementation (PRIMES)
- Stephanie Dickinson
- Xiwei Chen
- Valerie Flaherman
- Lance Pollack
- Mi-ok Kim
- David Allison
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Category: Project
Description: The PRIMES (Study 3) is a randomized clinical trial enrolling infants (n=324; 162 per site) in Guinea-Bissau and Uganda weighing ≥2000g at birth. Infants are randomized to one of two groups: 1) Early Small-Volume Supplementation (ESVS intervention group), which consists of up to 59 mL formula administered daily after breastfeeding through 30 days of age followed by exclusive breastfeeding through 6 months of age; or 2) frequent exclusive breastfeeding (EBF control) without any food or fluid other than vitamins, minerals and medications through 6 months of age. The proposed study will test the efficacy of early small-volume supplementation (ESVS) for increasing weight-for-age z-score (WAZ) at 1 month of age. Preregistration https://clinicaltrials.gov/ct2/show/NCT04704076
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