An interventional study of ESVS and Exclusive breastfeeding in Underweight, Wasting and Stunting, sponsored by University of California, San Francisco. Completed at 2 sites in 2 countries. Open to participants aged 0 Hours to 24 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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.
66 studies on the registry are indexed under Thinness; 11 are open to participants now.
This study's enrollment of 324 is above the median of 287 across 43 interventional studies indexed under Thinness.
Browse Thinness studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Infant with WHO newborn and respiratory danger signs present:
Maternal psychiatric or psychosocial barrier to enrollment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Recommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications
Other: Exclusive breastfeeding
Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age
Weight-for-age z-score (WAZ) at 30 days of age
WAZ calculated according to WHO Child Growth Standards
Time frame: 30 days of age
Weight-for-length z-score (WLZ) at 30 days of age
WLZ calculated according to WHO Child Growth Standards
Time frame: 30 days of age
Weight-for-length z-score (WLZ) at 180 days of age
WLZ calculated according to WHO Child Growth Standards
Time frame: 180 days of age
Weight-for-length z-score (WLZ) at 365 days of age
WLZ calculated according to WHO Child Growth Standards
Time frame: 365 days of age
Weight-for-age z-score (WLZ) at 180 days of age
WAZ calculated according to WHO Child Growth Standards
Time frame: 180 days of age
Weight-for-age z-score (WLZ) at 365 days of age
WAZ calculated according to WHO Child Growth Standards
Time frame: 365 days of age
Length-for-age z-score (LAZ) at 180 days of age
LAZ calculated according to WHO Child Growth Standards
Time frame: 180 days of age
Length-for-age z-score (LAZ) at 365 days of age
LAZ calculated according to WHO Child Growth Standards
Time frame: 365 days of age
Whether or not breastfeeding continues at 180 days of age
Continuation of breastfeeding
Time frame: 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
Time frame: 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
Time frame: 180 days of age
Neurodevelopment
Bayley Scales of Infant and Toddler Development, 3rd Edition
Time frame: 180 days of age
Neurodevelopment
Bayley Scales of Infant and Toddler Development, 3rd Edition
Time frame: 365 days of age
Brain volume
Low-field MRI
Time frame: 90 days of age
Brain volume
Low-field MRI
Time frame: 180 days of age
Brain volume
Low-field MRI
Time frame: 365 days of age
White matter volume
Conventional MRI
Time frame: 365 days of age
Plan to share: No
Ran from Feb 2021 to primary completion in Jan 2022, 10 months.
Of 22 interventional studies with no phase under Thinness, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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