Preventing Infant Malnutrition With Early Supplementation

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

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

Sponsors & Collaborators

• International Partnership for Human Development

  collaborator UNKNOWN

• Makerere University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Aberdeen

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Valerie Flaherman, MD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-28

Primary Completion

2022-01-14

Completion

2023-01-31

Countries

• Guinea-Bissau
• Uganda

Study Locations