Preventing Infant Malnutrition With Early Supplementation

NCT ID: NCT04704076

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2023-01-31

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.

Conditions

Underweight; Wasting; Stunting; Breastfeeding; Microbial Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

ESVS

Intervention Type: OTHER

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

Exclusive Breastfeeding

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

Group Type: ACTIVE_COMPARATOR

Exclusive breastfeeding

Intervention Type: OTHER

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

Interventions

ESVS

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

Intervention Type: OTHER

Exclusive breastfeeding

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 0 Hours
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Human Development

UNKNOWN

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Flaherman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

International Partnership for Human Development

Bissau, , Guinea-Bissau

Makerere University

Kampala, , Uganda

Countries

Guinea-Bissau; Uganda

References

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.

Reference Type: DERIVED

PMID: 35120150 (View on PubMed)

Other Identifiers

19-29405

Identifier Type: -

Identifier Source: org_study_id