We believe breast milk is the best food for infants. When in consultation with their healthcare professional, mothers and families find that optimal breastfeeding is not possible due to their infant’s medical condition, formulas for special medical purposes play a vital role in providing essential nutrients to infants. We have a global commitment to market breast-milk substitutes responsibly.

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Nestlé Health Science has presented new real world evidence from a post-market prospective surveillance on SMA® Alfamino® (Amino Acid Formula; North America*) in infants with CMA, severe CMA and malabsorptive conditions. This data was presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Conference 2019. The data demonstrated that there were no unexpected symptoms in both the overall or severe CMA population when fed with SMA® Alfamino® (North America). To view the abstract, visit here.

BACKGROUND

Amino acid-based formulas (AAF) are used in the dietary management of children with cows’ milk protein allergy (CMA), multiple food allergies or malabsorptive conditions. Allergy clinical practice guidelines recommend AAFs for infants and young children with symptoms that do not resolve with the use of an extensively hydrolysed formula (eHF).1-4


To our knowledge, this is the first post-market surveillance (PMS) study with an AAF. Post market surveillance programs provide real world setting safety monitoring data and add to the science of pharmacovigilance.

OBJECTIVES
  • Primary objective was to assess the frequency and nature of adverse events in infants fed an AAF.
  • Secondary objectives were to describe subject demographics and clinical characteristics of infants fed an AAF.

METHODS

The study was a prospective, PMS programme with an AAF (SMA® Alfamino®; North America) conducted from February 2017-May 2018 at 30 sites in the United States. Enrolment was open for 14 months with no limit to the number of infants to be enrolled and consent was obtained from caregivers for all Infants who met inclusion criteria.

RESULTS
  • 144 infants were enrolled and 88 (61%) were followed for 4 months (Table 1).
  • Within CMA population (N=100), 84% were classified as severe based on protocol criteria
  • Six serious adverse events (SAE) were reported in 6 subjects (3 subjects with severe CMA):
    • No SAE was deemed to be probable or definitely related to study formula.
  • 156 adverse events (AE) reported in 58 (40%) subjects (31 subjects with severe CMA [90 of 156 AE]).
    • 78% were reported as unrelated (122 of 156), 9% unlikely (14 of 156), 11% probably (17 of 156), and less than 1% definitely (1 of 156) related to study formula.
    • Vomiting and constipation were the most frequently reported events with probable association.
  • 114 caregivers assessed SMA® Alfamino®(North America) satisfaction with 91 (80%) reporting Yes (Figure 1)

Table 1. Subject Demographics (N=144)


Birth Enrolment
Male N= 71 (49%)
Female N = 73 (51%)
Mean [Std] Mean [Std]
Gestational birth age (weeks) 37.8 [3.1]
Age at enrollment (weeks) 21.0 [12.6]
N
Mean [Std]
N
Mean [Std]
Z-scores, weight (g) 117
-0.80 [1.8]
141
-1.04 [1.5]
Z-scores, length (cm) 102
-0.98 [3.7]
141
-1.08 [2.0]
WHO Percentiles, weight (g) 117
36.3 [31.5]
141
27.9 [30.4]
WHO Percentiles, length (cm) 102
45.9 [37.6]
141
29.8 [33.0]
Diagnosis
CMA 100 (69%)
Malabsorption 5 (3%)
Other 39 (27%)

Figure1. Caregiver Satisfaction

caregiver alfamino pie chart results
Conclusion
  • This post-market prospective surveillance of an amino acid infant formula in infants with CMA, severe CMA and malabsorptive conditions demonstrated no unexpected symptoms in both the overall or severe CMA population.
  • Use of amino acid infant formula (SMA® Alfamino®; North America) in infants with CMA and severe CMA, does not present with safety concerns.
  • 80% of Caregiver’s were satisfied with SMA® Alfamino®(North America) formula.

RELATED PRODUCTS

IMPORTANT NOTICE
Breastfeeding is best for babies. SMA® Alfamino® must only be used under strict medical supervision and after full consideration of the feeding options available, including breastfeeding. The advice of a doctor, midwife, health visitor, public health nurse, dietitian or pharmacist on the need for and proper method of use of infant milks and on all matters of infant feeding should be sought. Good maternal nutrition is important for the preparation and maintenance of breastfeeding. Introducing partial bottle-feeding may have a negative effect on breastfeeding and reversing a decision not to breastfeed is difficult. Social and financial implications should be considered when selecting a method of infant feeding. Infant milk should always be prepared and used as directed. Inappropriate foods or feeding methods, or improper use of infant formula, may present a health hazard.

REFERENCES
1. Cekola P, Henrikson A, Reichert H, Cohen S, Huhmann M B, Araujo Torres K. Clinical use and safety of an amino acid-based infant formula in a real world setting. Abstract presented at the annual NASPGHAN congress. Chicago, October 18, 2019.

*This study was conducted on the North American recipe variant of SMA® Alfamino®