NCT04704076

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 28, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 7, 2021

Last Update Submit

February 6, 2023

Conditions

UnderweightWastingStuntingBreastfeedingMicrobial Colonization

Outcome Measures

Primary Outcomes (1)

  • Weight-for-age z-score (WAZ) at 30 days of age

    WAZ calculated according to WHO Child Growth Standards

    30 days of age

Secondary Outcomes (16)

  • Weight-for-length z-score (WLZ) at 30 days of age

    30 days of age

  • Weight-for-length z-score (WLZ) at 180 days of age

    180 days of age

  • Weight-for-length z-score (WLZ) at 365 days of age

    365 days of age

  • Weight-for-age z-score (WLZ) at 180 days of age

    180 days of age

  • Weight-for-age z-score (WLZ) at 365 days of age

    365 days of age

  • +11 more secondary outcomes

Study Arms (2)

Early, Small-Volume Supplementation (ESVS)

EXPERIMENTAL

Breastfeeding with up to 59 mL formula daily until 30 days of age, followed by recommendation to breastfeed exclusively through 6 months of age

Other: ESVS

Exclusive Breastfeeding

ACTIVE COMPARATOR

Recommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications

Other: Exclusive breastfeeding

Interventions

ESVSOTHER

Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age

Early, Small-Volume Supplementation (ESVS)
Exclusive breastfeedingOTHER

Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age

Exclusive Breastfeeding

Eligibility Criteria

Age0 Hours - 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infant \< 6 hours old
  • Infant birth weight 2000-2885g
  • Mother intends to breastfeed
  • Mother with negative HIV test
  • Mother lives in study catchment area and anticipates availability for all study visits
  • Mother ≥18 years old

You may not qualify if:

  • Twins and other multiples
  • Infant with known major congenital anomalies including orofacial clefts, neural tube defects or congenital heart defects
  • Infant with WHO newborn and respiratory danger signs present:
  • Not feeding well
  • Convulsions
  • Very fast breathing ≥60 breaths/minute
  • Severe chest indrawing
  • No spontaneous movement
  • Lethargic or unconscious
  • Raised temperature \> 37.5 degrees Celsius
  • Hypothermia \<35.5 degrees Celsius
  • Any jaundice in first 24 hours of life or yellow palms or soles at any age
  • Head nodding, nasal flaring or grunting
  • Maternal psychiatric or psychosocial barrier to enrollment:
  • Contraindication to breastfeeding at each site as determined by a site's national or sub-national health authorities
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Partnership for Human Development

Bissau, Guinea-Bissau

Location

Makerere University

Kampala, Uganda

Location

Related Publications (1)

  • Ginsburg AS, Braima de Sa A, Nankabirwa V, Co R, Murungi J, Kim MO, Brim R, Namiiro F, Namugga O, Hartigan-O'Connor DJ, Roberts SB, Flaherman V. Randomized controlled trial of early, small-volume formula supplementation among newborns: A study protocol. PLoS One. 2022 Feb 4;17(2):e0263129. doi: 10.1371/journal.pone.0263129. eCollection 2022.

    PMID: 35120150DERIVED

MeSH Terms

Conditions

ThinnessCachexiaGrowth DisordersBreast FeedingCommunicable Diseases

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesPathologic ProcessesFeeding BehaviorBehaviorInfectionsDisease Attributes

Study Officials

  • Valerie Flaherman, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

February 28, 2021

Primary Completion

January 14, 2022

Study Completion

January 31, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)GU(1)