UnderweightPRIMESNCT04704076
Preventing Infant Malnutrition With Early Supplementation
A study testing ESVS and Exclusive breastfeeding in people with Underweight and Wasting, run by University of California, San Francisco at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Underweight, Wasting, Stunting
- What is being tested?
- ESVS and Exclusive breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Feb 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guinea-Bissau1 site
International Partnership for Human Development
Bissau
About this study
Official title: Preventing Infant Malnutrition With Early Supplementation, Aim 3
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
- Being tested
- ESVS, Exclusive breastfeeding
- Medical subject headings
- Thinness, Cachexia, Growth Disorders, Breast Feeding, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESVSOther
Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
Exclusive breastfeedingOther
Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ESVS |
| Exclusive Breastfeeding | Active comparator | Recommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications Receives: Other: Exclusive breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-age z-score (WAZ) at 30 days of age
WAZ calculated according to WHO Child Growth Standards
Measured: 30 days of age
Secondary outcomes (16)
Weight-for-length z-score (WLZ) at 30 days of age
WLZ calculated according to WHO Child Growth Standards
Measured: 30 days of age
Weight-for-length z-score (WLZ) at 180 days of age
WLZ calculated according to WHO Child Growth Standards
Measured: 180 days of age
Weight-for-length z-score (WLZ) at 365 days of age
WLZ calculated according to WHO Child Growth Standards
Measured: 365 days of age
Weight-for-age z-score (WLZ) at 180 days of age
WAZ calculated according to WHO Child Growth Standards
Measured: 180 days of age
Weight-for-age z-score (WLZ) at 365 days of age
WAZ calculated according to WHO Child Growth Standards
Measured: 365 days of age
Length-for-age z-score (LAZ) at 180 days of age
LAZ calculated according to WHO Child Growth Standards
Measured: 180 days of age
Length-for-age z-score (LAZ) at 365 days of age
LAZ calculated according to WHO Child Growth Standards
Measured: 365 days of age
Whether or not breastfeeding continues at 180 days of age
Continuation of breastfeeding
Measured: 180 days of age
Abundance of B.infantis in intestinal microbiota
Microbiota will be collected in DNA/RNA Shield Fecal Collection Tube containers (Zymo Research, Irvine, CA) and analyzed using 16S rRNA gene profiling
Measured: 30 days of age
Abundance of B.infantis in intestinal microbiota
Microbiota will be collected in DNA/RNA Shield Fecal Collection Tube containers (Zymo Research, Irvine, CA) and analyzed using 16S rRNA gene profiling
Measured: 180 days of age
Neurodevelopment
Bayley Scales of Infant and Toddler Development, 3rd Edition
Measured: 180 days of age
Neurodevelopment
Bayley Scales of Infant and Toddler Development, 3rd Edition
Measured: 365 days of age
Brain volume
Low-field MRI
Measured: 90 days of age
Brain volume
Low-field MRI
Measured: 180 days of age
Brain volume
Low-field MRI
Measured: 365 days of age
White matter volume
Conventional MRI
Measured: 365 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start28 Feb 2021
- Primary completion14 Jan 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UnderweightStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- International Partnership for Human Development, Makerere University, Bill and Melinda Gates Foundation, University of California, Davis, University of Aberdeen
- Responsible party
- Sponsor
- Investigators
- Valerie Flaherman, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704076
- Sponsor's protocol ID
- 19-29405
- Acronym
- PRIMES
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35120150
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Infant Malnutrition With Early Supplementation, Aim 3
- ClinicalTrials.gov ID
- NCT04704076
- Acronym / sponsor ID
- PRIMES / 19-29405
- Conditions
- Underweight, Wasting, Stunting, Breastfeeding, Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- International Partnership for Human Development, Makerere University, Bill and Melinda Gates Foundation, University of California, Davis, University of Aberdeen
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early, Small-Volume Supplementation (ESVS) | Experimental | Other: ESVSBreastfeeding with up to 59 mL formula daily until 30 days of age, followed by recommendation to breastfeed exclusively through 6 months of age |
| Exclusive Breastfeeding | Active comparator | Other: Exclusive breastfeedingRecommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Maternal psychiatric or psychosocial barrier to enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESVSBreastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age | Other | Early, Small-Volume Supplementation (ESVS) |
| Exclusive breastfeedingBreastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age | Other | Exclusive Breastfeeding |
Primary outcome
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
16 secondary outcomes
Weight-for-length z-score (WLZ) at 30 days of age
Time frame: 30 days of age
Weight-for-length z-score (WLZ) at 180 days of age
Time frame: 180 days of age
Weight-for-length z-score (WLZ) at 365 days of age
Time frame: 365 days of age
Weight-for-age z-score (WLZ) at 180 days of age
Time frame: 180 days of age
Weight-for-age z-score (WLZ) at 365 days of age
Time frame: 365 days of age
Length-for-age z-score (LAZ) at 180 days of age
Time frame: 180 days of age
Length-for-age z-score (LAZ) at 365 days of age
Time frame: 365 days of age
Whether or not breastfeeding continues at 180 days of age
Time frame: 180 days of age
Abundance of B.infantis in intestinal microbiota
Time frame: 30 days of age
Abundance of B.infantis in intestinal microbiota
Time frame: 180 days of age
Neurodevelopment
Time frame: 180 days of age
Neurodevelopment
Time frame: 365 days of age
Brain volume
Time frame: 90 days of age
Brain volume
Time frame: 180 days of age
Brain volume
Time frame: 365 days of age
White matter volume
Time frame: 365 days of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 35120150Ginsburg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Flaherman, MD, MPH principal investigator
University of California, San Francisco
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESVS and Exclusive breastfeeding in people with Underweight and Wasting, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guinea-Bissau, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-age z-score (WAZ) at 30 days of age (time frame: 30 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.