Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Mar 25;25(1):229.
doi: 10.1186/s12887-025-05446-6.

Growth and gastrointestinal tolerance of healthy formula-fed infants: a multicentre, prospective observational study

Luis Blesa-Baviera  1 , Ana Albors  2 , Pedro Samblas  3 , Úrsula Maraguat  4 , Cristóbal Coronel-Rodríguez  5 , Beatriz Abad  6 , Elena Viciano  7 , Francisco Javier Pérez-Sádaba  7 , Cecilia Martínez-Costa  8
Affiliations
Observational Study

Growth and gastrointestinal tolerance of healthy formula-fed infants: a multicentre, prospective observational study

Luis Blesa-Baviera et al. BMC Pediatr. .

Abstract

Background: Infant formula with human milk oligosaccharides (HMOs) and increased β-palmitate mimics breast milk nutritional composition and clinical benefits. We aimed to assess formula-fed infant growth, gastrointestinal tolerance, infections, and parental satisfaction with a partly fermented infant formula with an improved lipid profile (enriched with β-palmitate and docosahexaenoic/arachidonic acid) and short and long-chain oligosaccharides (scGOS/lcFOS [9:1]) and HMOs.

Methods: A prospective descriptive observational study in healthy infants with formula feeding or breastfeeding (reference population) was conducted in six Spanish primary care centres following routine clinical practice. In the first, second and fourth month of life visits sociodemographic, clinical, and anthropometric variables (weight, length, head circumference), stool consistency (Brussels Infant and Toddler Stool Scale [BITSS]), gastrointestinal symptoms, infections incidence and associated healthcare resource utilisation, and caregivers' satisfaction with formula were collected. A descriptive statistical analysis was performed (STATA-v.14). Growth was estimated as the mean (standard deviation) increase in the anthropometric variables and z-scores.

Results: A total of 61 formula-fed and 65 breastfed infants were included in the study (50.8% male). The average increase in weight, length and head circumference in the formula feeding and in the breastfeeding groups from the first to the fourth month of life was 2,566 (496) g, 9.7 (1.7) cm and 4.4 (1.0) cm, and 2,571 (702) g, 9.8 (1.8) cm and 4.4 (1.1) cm, respectively. The weight z-score was -0.1 (0.7) for formula-fed and 0.1 (1.1) for breastfed infants. In all visits, more than 88% of infants had loose/watery stools and most infants suffered gastrointestinal symptoms with low/medium frequency. In the fourth month of life visit, 16 (26.2%) formula-fed and 16 (24.6%) breastfed infants had infections, mainly respiratory, with 16% of formula-fed and 12% of breastfed infants requiring treatment. Most formula-feeding caregivers had a good/very good opinion of formula (85.2%). 75.4% infants drank the whole feeding bottle.

Conclusions: The growth, gastrointestinal tolerance, and incidence of infections of healthy formula-fed infants during the first four months of life were appropriate and in line with WHO standards. Formula feeding caregivers were satisfied with this partly fermented infant formula with an improved lipid profile and oligosaccharides.

Keywords: Breastfeeding; Formula feeding; Gastrointestinal tolerance; Growth; β-palmitate.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was evaluated and approved by the reference Ethics Committee for Research on Medicinal Products of the Hospital Clínico Universitario of Valencia. All parents or legal guardians of the subjects gave their written informed consent. Consent for publication: Not applicable. Competing interests: LBB and CMC have received honoraria and support from infant nutrition industries for participation in presentations, courses, expert committees, and support with registration, travel and accommodation for attending conferences related to paediatrics. EVD, FJPS work for an independent research entity and have received fees for their contribution to project development and medical writing. The rest of the authors declare no conflicts of interest related to this study. The rest of the authors declare no conflicts of interest related to this study. The funding source of this study (Nutricia-Danone Specialized Nutrition) did not interfere with the conduct, the analysis nor the interpretation of the study findings.

Figures

Fig. 1
Fig. 1
Study design and study variables. HCRU: Healthcare Resource Utilisation; BITSS: Brussels Infant and Toddler Stool Scale
Fig. 2
Fig. 2
Flow chart of patient recruitment
Fig. 3
Fig. 3
Formula feeding and breastfeeding infants’ growth. Formula feeding and breastfeeding infants mean weight (a), length (b) and head circumference (c) at the different visits. (d) Formula feeding and breastfeeding infants mean z-scores at the fourth month of life visit. Error bars represent standard deviation. *Statistically significant differences p = 0.010 (Mann-Whitney U test)
Fig. 4
Fig. 4
BITSS scale results of both groups at one, two and four months of life
See this image and copyright information in PMC

References

    1. World Health Organization (WHO). Breastfeeding. https://www.who.int/health-topics/breastfeeding#tab=tab_2. Accessed 16 October. 2023.
    1. Vandenplas Y, Berger B, Carnielli VP, Ksiazyk J, Lagstrom H, Sanchez Luna M, et al. Human milk oligosaccharides: 2’-Fucosyllactose (2’-FL) and Lacto-N-Neotetraose (LNnT) in infant Formula. Nutrients. 2018;10(9):1161. - PMC - PubMed
    1. Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, et al. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016;387(10017):475–90. - PubMed
    1. Pereyra-Elias R, Quigley MA, Carson C. To what extent does confounding explain the association between breastfeeding duration and cognitive development up to age 14? Findings from the UK Millennium Cohort Study. PLoS ONE. 2022;17(5):e0267326. - PMC - PubMed
    1. World Health Organization WHO. Infant and young child feeding. https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-.... Accessed 16 October 2023.

Publication types

Substances