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Growth in Infants with Cows’ Milk Allergy Fed an Amino Acid-Based Formula

Cows' Milk Allergy

31/03/2021

Objectives and Study:
To assess if an amino acid-based formula supports normal growth in infants with cow's milk protein allergy (CMPA).

Methods:
Infants aged 0-6 months with symptoms suggestive of CMPA (e.g. eczema, irritability, feeding problems, vomiting/regurgitation, persistent diarrhoea, rectal bleeding) were recruited from 10 clinical centres in China. After a baseline assessment, infants underwent a trial of an amino acid based formula (AAF; Alfamino^®, Nestlé Health Science, Switzerland) for two weeks. In infants older than 4 months, a complementary, cow's milk protein-free diet was allowed during the trial. After 2 weeks on AAF, infants underwent an open food challenge (OFC) with a cow's milk-based infant formula (CMF; NAN^®, Nestlé Nutrition, Switzerland). Those who reacted to CMF were diagnosed with CMPA and were offered to continue with AAF until 9 months of age (or until tolerant to cow's milk protein). Infants who tolerated CMF during the OFC underwent a one-week home challenge with CMF. Those who reacted during the home challenge phase were also classified as suffering from CMPA and allocated to treatment with AAF; tolerant infants remained on CMF and were discharged from the study. Birth weight and length were documented at enrolment. Growth parameters (body weight, length and head circumference) were measured at enrolment, after the AAF trial, and at final follow-up around 9 months of age. Weight-for-age, length-for-age and head circumference-for-age z scores (WAZ, LAZ, HCAZ) were calculated based on WHO growth standards.

Results:
Of 301 infants screened, 254 infants progressed to the AAF trial; 46 families withdrew early. Of the 254 infants who underwent the OFC, 150 (59.1%) were male; median age 16.1 weeks, interquartile range 9.9-20.3 weeks. 184 infants (72.4%) failed the OFC. Of the remaining 70 infants, 67 proceeded with an open 1-week CMF challenge at home. Of these, 43 (16.9%) reacted to CMF. A total of 227 infants (89.4%) were diagnosed as suffering from CMPA and remained on AAF and a cow's milk protein-free diet until 9 months of age. Follow-up data to the 9-month visit were available for 220 infants. Anthropometric data are summarised in Table 1. During the study period, mean body weight, length and head circumference increased in line with WHO growth standards, confirming normal growth velocity. Mean WAZ, LAZ and HCAZ were close to 0 (i.e. 50th WHO percentile), with maximum changes in z scores of less than 0.25 standard deviations (WAZ +0.23, LAZ +0.16, HCAZ +0.10) from enrolment to final visit.

Conclusions:
Infants with challenge-proven CMPA achieved normal weight gain, linear growth and head growth while being fed an amino acid-based formula, together with a cow´s milk protein-free elimination diet, during the first 9 months of life.

Reference:
Growth in infants with cow's milk protein allergy fed an amino acid-based formula. Yvan Vandenplas, Christophe Dupont, Philippe Eigenmann, Arne Høst, Mikael Kuitunen, Carmen Ribes-Koninkx, Neil Shah, Hania Szajewska, Andrea von Berg, Rajat Mukherjee, Ralf G. Heine, Zhengyan Zhao, on behalf of the Chinese Investigator Team. Abstract presented at the annual ESPGHAN congress, June 6. JPGN Volume 68, Supplement 1, May 2019.

IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.

To assess if an amino acid-based formula supports normal growth in infants with cow's milk protein allergy (CMPA).

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