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. 2023 Jul 31:11:1230905.
doi: 10.3389/fped.2023.1230905. eCollection 2023.

Growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula in infants with cow's milk protein allergy

Aydan Kansu  1 , Nafiye Urganci  2 , Aysegul Bukulmez  3 , Gunsel Kutluk  4 , Didem Gulcu Taskin  5 , Lutfiye Sahin Keskin  2 , Mahir Igde  6 , Lutfi Molon  3 , Yasar Dogan  7 , Bulent Enis Sekerel  8 , Mutlu Yuksek  9 , Ilknur Bostanci  10 , Nelgin Gerenli  11 , Esra Polat  11 , Buket Dalgic  12 , Hasret Ayyildiz  13 , Merve Usta  2 , Ahmet Basturk  14 , Ozlem Yuce Kirmemis  15 , Ceyda Tuna Kirsaclioglu  1 , Hacer Fulya Gulerman  16 , Aysugul Alptekin Sarioglu  17 , Simge Erdogan  17
Affiliations

Growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula in infants with cow's milk protein allergy

Aydan Kansu et al. Front Pediatr. .

Abstract

Objective: To evaluate growth, tolerance and safety outcomes with use of an extensively hydrolyzed casein-based formula (eHCF) in infants with cow's milk protein allergy (CMPA).

Methods: A total of 226 infants (mean ± SD age: 106.5 ± 39.5 days, 52.7% were girls) with CMPA who received eHCF comprising at least half of the daily dietary intake were included. Data on anthropometrics [weight for age (WFA), length for age (LFA) and weight for length (WFL) z-scores] were recorded at baseline (visit 1), while data on infant feeding and stool records, anthropometrics and Infant Feeding and Stool Patterns and Formula Satisfaction Questionnaires were recorded at visit 2 (on Days 15 ± 5) and visit 3 (on Days 30 ± 5).

Results: From baseline to visit 2 and visit 3, WFA z-scores (from -0.60 ± 1.13 to -0.54 ± 1.09 at visit 2, and to -0.44 ± 1.05 at visit 3, p < 0.001) and WFL z-scores (from -0.80 ± 1.30 to -0.71 ± 1.22 at visit 2, and to -0.64 ± 1.13 at visit 3, p = 0.002) were significantly increased. At least half of infants never experienced irritability or feeding refusal (55.7%) and spit-up after feeding (50.2%). The majority of mothers were satisfied with the study formula (93.2%), and wished to continue using it (92.2%).

Conclusions: In conclusion, eHCF was well-accepted and tolerated by an intended use population of infants ≤ 6 months of age with CMPA and enabled adequate volume consumption and improved growth indices within 30 days of utilization alongside a favorable gastrointestinal tolerance and a high level of parental satisfaction.

Keywords: cow’s milk protein allergy; extensively hydrolyzed casein-based formula; gastrointestinal intolerance; growth indices; parental satisfaction; stool patterns.

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Conflict of interest statement

AS and SE are Abbott employees. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Weight for age (WFA) Z-scores from baseline to visit 3, *p < 0.001 compared to baseline visit.
Figure 2
Figure 2
Weight for length (WFL) Z-scores from baseline to visit 3, *p < 0.01 compared to baseline visit.
See this image and copyright information in PMC

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