GRADE Evidence Profile: F-100 compared to diluted F-100 for infants <6 months of age with severe wasting and/or oedema Author(s): Tomori et al.

Question: F-100 compared to diluted F-100 for infants <6 months with severe wasting and/or oedema.</p

Summary of included studies (Islam et al 2020 [48], Wilkinson 2008 [49]).

Summary of included studies (Islam et al 2020 [48], Wilkinson 2008 [49]).</p

Search strategy.

In 2020, 149.2 million children worldwide under 5 years suffered from stunting, and 45.4 million experienced wasting. Many infants are born already stunted, while others are at high risk for growth faltering early after birth. Growth faltering is linked to transgenerational impacts of poverty and marginalization. Few interventions address growth faltering in infants under 6 months, despite a likely increasing prevalence due to the negative global economic impacts of the COVID-19 pandemic. Breastfeeding is a critical intervention to alleviate malnutrition and improve child health outcomes, but rarely receives adequate attention in growth faltering interventions. A systematic review and meta-analysis were undertaken to identify and evaluate interventions addressing growth faltering among infants under 6 months that employed supplemental milks. The review was carried out following guidelines from the USA National Academy of Medicine. A total of 10,405 references were identified, and after deduplication 7390 studies were screened for eligibility. Of these, 227 were assessed for full text eligibility and relevance. Two randomized controlled trials were ultimately included, which differed in inclusion criteria and methodology and had few shared outcomes. Both studies had small sample sizes, high attrition and high risk of bias. A Bangladeshi study (n = 153) found significantly higher rates of weight gain for F-100 and diluted F-100 (DF-100) compared with infant formula (IF), while a DRC trial (n = 146) did not find statistically significant differences in rate of weight gain for DF-100 compared with IF offered in the context of broader lactation and relactation support. The meta-analysis of rate of weight gain showed no statistical difference and some evidence of moderate heterogeneity. Few interventions address growth faltering among infants under 6 months. These studies have limited generalizability and have not comprehensively supported lactation. Greater investment is necessary to accelerate research that addresses growth faltering following a new research framework that calls for comprehensive lactation support.</div

GRADE Evidence Profile: Diluted F-100 compared to infant formula for infants <6 months of age with severe wasting and/or oedema Author(s): Tomori et al.

Question: Diluted F-100 compared to infant formula for infants <6 months with severe wasting and/or oedema.</p

GRADE Evidence Profile: F-100 compared to infant formula for infants <6 months of age with severe wasting and/or oedema Author(s): Tomori et al.

Question: F-100 compared to infant formula for infants <6 months with severe wasting and/or oedema.</p

Excluded studies after discussion.

In 2020, 149.2 million children worldwide under 5 years suffered from stunting, and 45.4 million experienced wasting. Many infants are born already stunted, while others are at high risk for growth faltering early after birth. Growth faltering is linked to transgenerational impacts of poverty and marginalization. Few interventions address growth faltering in infants under 6 months, despite a likely increasing prevalence due to the negative global economic impacts of the COVID-19 pandemic. Breastfeeding is a critical intervention to alleviate malnutrition and improve child health outcomes, but rarely receives adequate attention in growth faltering interventions. A systematic review and meta-analysis were undertaken to identify and evaluate interventions addressing growth faltering among infants under 6 months that employed supplemental milks. The review was carried out following guidelines from the USA National Academy of Medicine. A total of 10,405 references were identified, and after deduplication 7390 studies were screened for eligibility. Of these, 227 were assessed for full text eligibility and relevance. Two randomized controlled trials were ultimately included, which differed in inclusion criteria and methodology and had few shared outcomes. Both studies had small sample sizes, high attrition and high risk of bias. A Bangladeshi study (n = 153) found significantly higher rates of weight gain for F-100 and diluted F-100 (DF-100) compared with infant formula (IF), while a DRC trial (n = 146) did not find statistically significant differences in rate of weight gain for DF-100 compared with IF offered in the context of broader lactation and relactation support. The meta-analysis of rate of weight gain showed no statistical difference and some evidence of moderate heterogeneity. Few interventions address growth faltering among infants under 6 months. These studies have limited generalizability and have not comprehensively supported lactation. Greater investment is necessary to accelerate research that addresses growth faltering following a new research framework that calls for comprehensive lactation support.</div

Meta-analysis of weight gain.

In 2020, 149.2 million children worldwide under 5 years suffered from stunting, and 45.4 million experienced wasting. Many infants are born already stunted, while others are at high risk for growth faltering early after birth. Growth faltering is linked to transgenerational impacts of poverty and marginalization. Few interventions address growth faltering in infants under 6 months, despite a likely increasing prevalence due to the negative global economic impacts of the COVID-19 pandemic. Breastfeeding is a critical intervention to alleviate malnutrition and improve child health outcomes, but rarely receives adequate attention in growth faltering interventions. A systematic review and meta-analysis were undertaken to identify and evaluate interventions addressing growth faltering among infants under 6 months that employed supplemental milks. The review was carried out following guidelines from the USA National Academy of Medicine. A total of 10,405 references were identified, and after deduplication 7390 studies were screened for eligibility. Of these, 227 were assessed for full text eligibility and relevance. Two randomized controlled trials were ultimately included, which differed in inclusion criteria and methodology and had few shared outcomes. Both studies had small sample sizes, high attrition and high risk of bias. A Bangladeshi study (n = 153) found significantly higher rates of weight gain for F-100 and diluted F-100 (DF-100) compared with infant formula (IF), while a DRC trial (n = 146) did not find statistically significant differences in rate of weight gain for DF-100 compared with IF offered in the context of broader lactation and relactation support. The meta-analysis of rate of weight gain showed no statistical difference and some evidence of moderate heterogeneity. Few interventions address growth faltering among infants under 6 months. These studies have limited generalizability and have not comprehensively supported lactation. Greater investment is necessary to accelerate research that addresses growth faltering following a new research framework that calls for comprehensive lactation support.</div

PRISMA 2020 checklist.

In 2020, 149.2 million children worldwide under 5 years suffered from stunting, and 45.4 million experienced wasting. Many infants are born already stunted, while others are at high risk for growth faltering early after birth. Growth faltering is linked to transgenerational impacts of poverty and marginalization. Few interventions address growth faltering in infants under 6 months, despite a likely increasing prevalence due to the negative global economic impacts of the COVID-19 pandemic. Breastfeeding is a critical intervention to alleviate malnutrition and improve child health outcomes, but rarely receives adequate attention in growth faltering interventions. A systematic review and meta-analysis were undertaken to identify and evaluate interventions addressing growth faltering among infants under 6 months that employed supplemental milks. The review was carried out following guidelines from the USA National Academy of Medicine. A total of 10,405 references were identified, and after deduplication 7390 studies were screened for eligibility. Of these, 227 were assessed for full text eligibility and relevance. Two randomized controlled trials were ultimately included, which differed in inclusion criteria and methodology and had few shared outcomes. Both studies had small sample sizes, high attrition and high risk of bias. A Bangladeshi study (n = 153) found significantly higher rates of weight gain for F-100 and diluted F-100 (DF-100) compared with infant formula (IF), while a DRC trial (n = 146) did not find statistically significant differences in rate of weight gain for DF-100 compared with IF offered in the context of broader lactation and relactation support. The meta-analysis of rate of weight gain showed no statistical difference and some evidence of moderate heterogeneity. Few interventions address growth faltering among infants under 6 months. These studies have limited generalizability and have not comprehensively supported lactation. Greater investment is necessary to accelerate research that addresses growth faltering following a new research framework that calls for comprehensive lactation support.</div

Research framework to guide the design of future studies to inform comprehensive evidence-based guidelines for recovery from growth faltering in infants <6 months.

Note: Supplemental milk is defined as donor human milk, fortified donor human milk, fortified mothers’ own milk, human milk from wet nurse, commercial infant formula, nutrient-enriched commercial infant formula, F-75, F-100, or diluted F-100.</p

PRISMA flow chart.

In 2020, 149.2 million children worldwide under 5 years suffered from stunting, and 45.4 million experienced wasting. Many infants are born already stunted, while others are at high risk for growth faltering early after birth. Growth faltering is linked to transgenerational impacts of poverty and marginalization. Few interventions address growth faltering in infants under 6 months, despite a likely increasing prevalence due to the negative global economic impacts of the COVID-19 pandemic. Breastfeeding is a critical intervention to alleviate malnutrition and improve child health outcomes, but rarely receives adequate attention in growth faltering interventions. A systematic review and meta-analysis were undertaken to identify and evaluate interventions addressing growth faltering among infants under 6 months that employed supplemental milks. The review was carried out following guidelines from the USA National Academy of Medicine. A total of 10,405 references were identified, and after deduplication 7390 studies were screened for eligibility. Of these, 227 were assessed for full text eligibility and relevance. Two randomized controlled trials were ultimately included, which differed in inclusion criteria and methodology and had few shared outcomes. Both studies had small sample sizes, high attrition and high risk of bias. A Bangladeshi study (n = 153) found significantly higher rates of weight gain for F-100 and diluted F-100 (DF-100) compared with infant formula (IF), while a DRC trial (n = 146) did not find statistically significant differences in rate of weight gain for DF-100 compared with IF offered in the context of broader lactation and relactation support. The meta-analysis of rate of weight gain showed no statistical difference and some evidence of moderate heterogeneity. Few interventions address growth faltering among infants under 6 months. These studies have limited generalizability and have not comprehensively supported lactation. Greater investment is necessary to accelerate research that addresses growth faltering following a new research framework that calls for comprehensive lactation support.</div