NCT04704076: PRIMES

Preventing Infant Malnutrition With Early Supplementation

Completed NA Last updated 8 February 2023

What this trial tests

NA trial testing ESVS in Underweight in 324 participants. Completed in 31 January 2023.

Timeline

28 February 2021

Primary endpoint
14 January 2022

31 January 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	324
Start date	28 February 2021
Primary completion	14 January 2022
Estimated completion	31 January 2023
Sites	2 locations across Uganda, Guinea-Bissau

Drugs / interventions tested

• ESVS
• Exclusive breastfeeding

Conditions studied

• Underweight — all drugs for Underweight →
• Wasting — all drugs for Wasting →
• Stunting — all drugs for Stunting →
• Breastfeeding — all drugs for Breastfeeding →

Sponsor

University of California, San Francisco

Who can join

Adults 0 Hours to 24 Hours, any sex, with Underweight or Wasting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol.
   Ginsburg AS, Braima de Sa A, Nankabirwa V, Co R, et al · · 2022 · cited 10× · PMID 35120150 · DOI 10.1371/journal.pone.0263129
2. Lay health workers in primary and community health care for maternal and child health: identification and treatment of wasting in children.
   Papadopoulou E, Lim YC, Chin WY, Dwan K, et al · · 2023 · cited 2× · PMID 37646367 · DOI 10.1002/14651858.cd015311