Preventing Infant Malnutrition With Early Supplementation
Condition: Underweight; Wasting; Stunting; Breastfeeding; Microbial Colonization
MeSH terms: Communicable Diseases; Infections; Malnutrition; Infant Nutrition Disorders; Thinness
Study type: Interventional

Summary: 
      Background: Worldwide, more than 50 million children under 5 years of age are wasted
      (weight-for-length/height Z-score (WLZ) <-2) and over 150 million children under 5 are
      stunted (length/height-for-age Z-score (LAZ) <-2); such wasting and stunting often begin
      during infancy.1 Optimal nutrition can prevent wasting and stunting. Exclusive breastfeeding
      (EBF) is widely recommended by community health workers, doctors and nurses and provides
      optimal nutrition for most infants. However, early growth faltering is common for infants in
      low and middle income countries (LMIC) and can both increase an infant's risk of early
      mortality and also lead to deficits in attained height and weight throughout childhood. Thus
      research is needed to determine the most efficacious strategy to promote healthy early growth
      in LMIC.

      Objective: 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.

      Methodology: The PRIMES pilot (Study 3) will be a randomized clinical trial enrolling infants
      in Guinea-Bissau and Uganda weighing ≥2000g at birth. Infants weighing 2000-2499g at <6 hours
      of age (n=144; 72 per site) will be randomized on enrollment 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 EBF through 6
      months of age; or 2) frequent exclusive breastfeeding without any food or fluid other than
      vitamins, minerals and medications (control) through 6 months of age. Infants weighing
      2500-3300g at <6 hours of age will be weighed again at 4 days of age; those weighing <2600g
      at 4 days of age (n=180; 90 per site) will be randomized to the same intervention and control
      groups. Weight will be measured on all enrolled babies at birth on Day 1 and at 4, 14, 30, 60
      and 180 days of age and additional measures including height, MUAC, skinfolds, and hemoglobin
      will be assessed at other time points. The study's primary outcome will be WAZ at 1 month of
      age. Secondary outcomes will include WLZ at 1 month of age; WAZ, WLZ and LAZ through 6 months
      of age; breastfeeding duration and infant intestinal microbiota.
    


Intervention name(s): ESVS; Exclusive breastfeeding
Intervention type(s): Other; Other
Intervention description(s): Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age; Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention