Preventing Infant Malnutrition With Early Supplementation

Breastfeeding Clinical Trial

— PRIMES  

Official title:

Preventing Infant Malnutrition With Early Supplementation, Aim 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704076
• Other study ID #: 19-29405
• Status: Completed
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: January 31, 2023
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Hours to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Communicable Diseases
• Infant Nutrition Disorders
• Infections
• Malnutrition
• Microbial Colonization
• Stunting
• Thinness
• Underweight
• Wasting

Intervention

Other:
• ESVS
Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
• Exclusive breastfeeding
Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age

Locations

Country	Name	City	State
Guinea-Bissau	International Partnership for Human Development	Bissau
Uganda	Makerere University	Kampala

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, International Partnership for Human Development, Makerere University, University of Aberdeen, University of California, Davis

Countries where clinical trial is conducted

Guinea-Bissau,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight-for-age z-score (WAZ) at 30 days of age	WAZ calculated according to WHO Child Growth Standards	30 days of age
Secondary	Weight-for-length z-score (WLZ) at 30 days of age	WLZ calculated according to WHO Child Growth Standards	30 days of age
Secondary	Weight-for-length z-score (WLZ) at 180 days of age	WLZ calculated according to WHO Child Growth Standards	180 days of age
Secondary	Weight-for-length z-score (WLZ) at 365 days of age	WLZ calculated according to WHO Child Growth Standards	365 days of age
Secondary	Weight-for-age z-score (WLZ) at 180 days of age	WAZ calculated according to WHO Child Growth Standards	180 days of age
Secondary	Weight-for-age z-score (WLZ) at 365 days of age	WAZ calculated according to WHO Child Growth Standards	365 days of age
Secondary	Length-for-age z-score (LAZ) at 180 days of age	LAZ calculated according to WHO Child Growth Standards	180 days of age
Secondary	Length-for-age z-score (LAZ) at 365 days of age	LAZ calculated according to WHO Child Growth Standards	365 days of age
Secondary	Whether or not breastfeeding continues at 180 days of age	Continuation of breastfeeding	180 days of age
Secondary	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	30 days of age
Secondary	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	180 days of age
Secondary	Neurodevelopment	Bayley Scales of Infant and Toddler Development, 3rd Edition	180 days of age
Secondary	Neurodevelopment	Bayley Scales of Infant and Toddler Development, 3rd Edition	365 days of age
Secondary	Brain volume	Low-field MRI	90 days of age
Secondary	Brain volume	Low-field MRI	180 days of age
Secondary	Brain volume	Low-field MRI	365 days of age
Secondary	White matter volume	Conventional MRI	365 days of age