Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

Washington University School of Medicine2,897 enrolled

Overview

An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,897

Conditions

Severe Acute Malnutrition

Interventions

Amoxicillin

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 6-59 months * An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes * Mid Upper Arm Circumference \<11.5 cm, weight-for-height z-score \< -3, or bilateral pitting edema on the dorsum of the feet Exclusion Criteria: * Participation in any other ongoing study or supplementary feeding program * Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy

Outcomes

Primary Outcomes

Neurocognitive outcome

Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population * The scale title is "Malawi Developmental Assessment Tool z-score" * The primary outcome is Global z-score, titled "Global z-sore" * Secondary outcomes are 4 sub-domain z-scores are titled "Gross motor z-score", "Fine motor z-score", Language z-score", and "Social z-score"

Time frame: Time Frame: 4 to 7 months after nutritional outcome

Neurocognitive outcome

Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores * The scale title is "Intention Score" * Problem 1 is scored 0 - 4 * Problem 2 is scored 0 - 4 * Problem 3 is scored 0 - 8

Time frame: Time Frame: within 4 weeks after nutritional outcome

Secondary Outcomes

Nutritional recovery

Defined by resolution of edema AND mid-upper arm circumference \[MUAC\] \>12.4cm, AND/OR a weight/height z-score \[WHZ\] \>-3

Time frame: Up to 12 weeks following enrollment

Attentional orienting speed

Measured by mean saccade latency to peripheral targets

Time frame: 4-7 months after nutritional after nutritional outcome

Adverse Events

Measured by number of days diarrhea and/or rashes.

Time frame: Fortnightly follow up visits up to 12 weeks following enrollment

Acceptance of RUTF

Mother's report of if the child ate the food well. This is a yes or no question.