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Preventing Infant Malnutrition With Early Supplementation (PRIMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704076
Recruitment Status : Active, not recruiting
First Posted : January 11, 2021
Last Update Posted : February 24, 2022
Sponsor:
Collaborators:
International Partnership for Human Development
Makerere University
Bill and Melinda Gates Foundation
University of California, Davis
University of Aberdeen
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.


Condition or disease Intervention/treatment Phase
Underweight Wasting Stunting Breastfeeding Microbial Colonization Other: ESVS Other: Exclusive breastfeeding Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Infant Malnutrition With Early Supplementation, Aim 3
Actual Study Start Date : February 28, 2021
Actual Primary Completion Date : January 14, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Early, Small-Volume Supplementation (ESVS)
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
Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
Active Comparator: Exclusive Breastfeeding
Recommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications
 Other: Exclusive breastfeeding
Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age


Outcome Measures
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Primary Outcome Measures :
  1. Weight-for-age z-score (WAZ) at 30 days of age [ Time Frame: 30 days of age ]
    WAZ calculated according to WHO Child Growth Standards


Secondary Outcome Measures :
  1. Weight-for-length z-score (WLZ) at 30 days of age [ Time Frame: 30 days of age ]
    WLZ calculated according to WHO Child Growth Standards

  2. Weight-for-length z-score (WLZ) at 180 days of age [ Time Frame: 180 days of age ]
    WLZ calculated according to WHO Child Growth Standards

  3. Weight-for-age z-score (WLZ) at 180 days of age [ Time Frame: 180 days of age ]
    WAZ calculated according to WHO Child Growth Standards

  4. Length-for-age z-score (LAZ) at 180 days of age [ Time Frame: 180 days of age ]
    LAZ calculated according to WHO Child Growth Standards

  5. Whether or not breastfeeding continues at 180 days of age [ Time Frame: 180 days of age ]
    Continuation of breastfeeding

  6. Abundance of B.infantis in intestinal microbiota [ Time Frame: 30 days of age ]
    Microbiota will be collected in DNA/RNA Shield Fecal Collection Tube containers (Zymo Research, Irvine, CA) and analyzed using 16S rRNA gene profiling

  7. Abundance of B.infantis in intestinal microbiota [ Time Frame: 180 days of age ]
    Microbiota will be collected in DNA/RNA Shield Fecal Collection Tube containers (Zymo Research, Irvine, CA) and analyzed using 16S rRNA gene profiling


Eligibility Criteria
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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • Mothers unable or unwilling to complete all aspects of the protocol Infant enrolled in another study
    • Mother has had another infant enrolled in PRIMES
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704076


Locations
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Guinea-Bissau
International Partnership for Human Development
Bissau, Guinea-Bissau
Uganda
Makerere University
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
International Partnership for Human Development
Makerere University
Bill and Melinda Gates Foundation
University of California, Davis
University of Aberdeen
Investigators
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Principal Investigator: Valerie Flaherman, MD, MPH University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04704076    
Other Study ID Numbers: 19-29405
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Malnutrition
Infant Nutrition Disorders
Thinness
 Nutrition Disorders
Body Weight
Pathologic Processes
Disease Attributes