NCT04704076

Preventing Infant Malnutrition With Early Supplementation

Preventing Infant Malnutrition With Early Supplementation, Aim 3

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 0 Hours – 24 Hours
• Healthy volunteers: Accepted

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.

Conditions

• Underweight
• Wasting
• Stunting
• Breastfeeding
• Microbial Colonization

Interventions

Type	Name	Description
OTHER	ESVS	Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
OTHER	Exclusive breastfeeding	Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age

Timeline

• Start date: 2021-02-28
• Primary completion: 2022-01-14
• Completion: 2023-01-31
• First posted: 2021-01-11
• Last updated: 2023-02-08

Locations

2 sites across 2 countries: Guinea-Bissau, Uganda