Exclusive human milk feeding and prevalence of early adiposity rebound in ELBW infants: a retrospective cohort study.

The purpose of the present study was to evaluate the prevalence of early adiposity rebound (EAR) and factors associated with its occurrence in a cohort of extremely low birth weight infants (ELBW). We conducted a retrospective longitudinal study including ELBW infants followed-up for up to 10 years after discharge. EAR was defined as occurring before 5 years of age. A multivariate binary logistic regression analysis was performed to evaluate maternal and perinatal variables independently associated with EAR. Out of 212 ELBW infants included in the analysis, 40.6% developed EAR and 21.5% showed it before 4 years of age. Only formula milk feeding at discharge was independently associated with a higher risk of EAR. The mean BMI of children with EAR was higher than that of children without EAR. Furthermore, the prevalence of overweight and obesity was higher in the EAR group than in the timely AR group.  Conclusions: ELBW infants in our cohort developed EAR in a relatively high percentage of cases. In this already at-risk population, EAR may represent a further risk factor for an adverse metabolic outcome. Monitoring preterm infants' growth within a long-term follow-up program and promoting and supporting human milk feeding is advisable. What is Known: • Preterm-born infants are at high risk for long-term adverse health outcomes, especially cardiovascular and metabolic. • The occurrence of early adiposity rebound (EAR) is associated with the risk of later obesity and metabolic syndrome. What is New: • The occurrence of EAR in ELBW infants may represent an additional risk factor for later adverse metabolic outcomes in an already vulnerable population. • Future preventive strategies should include a long-term follow-up and the promotion of exclusive breastfeeding.

Association between co-sleeping in the first year of life and preschoolers´ sleep patterns.

This study aimed to investigate the association between co-sleeping practiced during the first year of life and preschoolers' sleep patterns. A cross-sectional study including toddlers was designed to analyze their sleep patterns. The Brief Infant Sleep Questionnaire, validated in Spanish, was used to measure sleep quality. A latent class analysis was performed to identify qualitative subgroups in the sample and explore the effects of co-sleeping. The sleep patterns of 276 children were analyzed. A total of 181 (65%) parents reported having practiced co-sleeping with their children. The latent class analysis identified a two-class solution with two different sleep patterns. One of them showed a worse quality sleep pattern, which had a significant association with having practiced co-sleeping during the first year of life, and with the fact that they were still sleeping in the parents' room, among other characteristics related to co-sleeping and parental concerns. Breastfeeding also showed association with a worse quality sleep pattern.  Conclusion: Based on the present findings, co-sleeping during the first year of life appears to be associated with poor sleep patterns in young preschoolers. What is Known: • Co-sleeping shows benefits for infants and parents, mainly facilitating successful breastfeeding. • Literature on the effect of co-sleeping in lately sleep quality in children and their parents is very limited. What is New: • Co-sleeping practiced during the first year of life could be associated with a worse sleep pattern measured with BISQ-E tool. • A balance between the correct practice of co-sleeping and the achievement of a healthy sleep routine in preschool should probably be part of parents' health education.

From womb to world: mapping gut microbiota-related health literacy among Italian mothers, a cross-sectional study.

BACKGROUND: The gut microbiota is a key determinant of long-term health. Promoting maternal health literacy may enhance children well-being. Aim of the present study was to assess gut microbiota-related health literacy of Italian women and identify potential gaps in awareness. METHODS: A cross-sectional survey study was conducted using an online questionnaire (17 questions) on determinants and long-term impact of infant gut microbiota. The survey targeted Italian pregnant women and mothers of children under 2 years old, and was distributed through various social media channels between September 28th and November 15th, 2022. A total score was calculated as the sum of positive answers. Data on demographics, pregnancy status, and pre-existing knowledge of the infant gut microbiota were also collected. Descriptive and inferential statistics were applied. RESULTS: The questionnaire was completed by 1076 women. Median total score was 9 [7-11]. The 81.7% of respondents declared prior knowledge of the gut microbiota. The internet was among the most commonly cited primary sources of information. Independent predictors of total score were having a university degree (B = 0.656, p = 0.002) and prior knowledge (B = 2.246, p < 0.001). Conversely, older age was associated with lower total scores (B = -0.092, p < 0.001). The least known determinants of infant gut microbiota were gestational BMI, prematurity, mode of delivery and NICU stay. Pregnant women failed to recognize the role of breastfeeding in the development of infant gut microbiota more frequently than non-pregnant women. The 97.5% of participants reported increased interest in the gut microbiota, with heightened interest associated with prior knowledge. CONCLUSIONS: Our study revealed a moderate level of knowledge about infant gut microbiota among respondents, emphasizing the positive impact of prior knowledge on understanding and interest. Targeted educational interventions are needed to address awareness gaps, especially concerning the influence of breastfeeding on infant gut microbiota. Healthcare providers have the potential to enhance women's knowledge and awareness of this topic.

Can Postbiotics Represent a New Strategy for NEC?

Intestinal bacteria, also known as gut microbiota, are a rich ecology of microorganisms found in the human digestive tract. Extensive study has highlighted their critical relevance in preserving human health. New research has revealed that bacterial viability is not invariably necessary to induce health benefits. Postbiotics (defined soluble substances produced as a byproduct of the metabolic processes of living microbes) have thus emerged as an important topic of research. They contribute to shaping the gut microbiota, exert immune-modulation activity, and improve the integrity of the gut barrier.Alterations in preterm gut colonization associated with intestinal barrier immaturity and the increased reactivity of the intestinal mucosa to colonizing bacteria have been implicated in the pathogenesis of necrotizing enterocolitis. Postbiotics have shown promising outcomes in reducing the risk of developing NEC, lowering inflammation, encouraging the development of good bacteria, and strengthening the intestinal barrier. This is an important advancement in newborn care and highlights the potential of postbiotics to avoid severe intestinal disorders.

Postnatal growth of small for gestational age late preterm infants: determinants of catch-up growth.

BACKGROUND: Failure to recover growth is a risk reported in late preterm population. This study aimed to evaluate the auxological outcome of late preterm infants and identify factors associated with failure to recover growth. METHODS: We enrolled late preterm infants with birth weight ≤10th percentile, followed up at High-Risk Infant Follow-up Service. We collected data at birth and at follow-up visits. A logistic regression analysis was performed to assess variables independently associated with growth failure. RESULTS: The population consisted of 175 preterms. The percentage of children showing no weight recovery was 34% at 36 months. At logistic regression analysis, infants who had not regained weight at 12 months had a higher risk of not regaining weight even at 36 months. The same risk factor was highlighted for length catch-up growth. Moreover, infants fed any human milk at discharge were protected from not achieving both weight and length catch-up growth at 36 months. CONCLUSION: These results indicate that children born late preterm and small for gestational age could fail to recover weight and stature growth in the first 36 months. The protective effect of human milk on failure to thrive highlights the importance of promoting breastfeeding in this population. IMPACT: A significant number of SGA late preterms show a failure to recover weight and statural growth. Having experienced intrauterine growth restriction is associated with a greater chance of achieving statural catch-up growth. Being born singleton represents a risk factor for slower weight and height growth velocity. Breastmilk has a protective effect on failure to recover adequate weight and length in preterm SGA infants. This finding highlights the importance of promoting breastfeeding in this population.

Perception, knowledge and attitude towards childhood fever: A survey among final-year medical students.

AIMS: Undue concerns about the consequences of fever and its inappropriate management have been documented worldwide among physicians. However, no data exist on medical students. We investigated the perception, knowledge and attitude towards childhood fever among final-year medical students. METHODS: Between June and September 2021, final-year medical students of six Italian universities were invited to complete an online survey on their conceptions and attitude towards pharmacological and non-pharmacological management of childhood fever. History of relevant personal or second-hand experience with childhood fever was also addressed. Both quantitative and qualitative approaches were used. RESULTS: Of 1095 (69%) final-year medical students, 756 completed the survey. Many students believe that high fever might cause brain damage, would recommend physical methods and alternate two drugs for fever. Most students do not think that fever has mainly beneficial effects. In Northern Italy, students are less likely to believe that fever might lead to brain damage (OR 0.55, 95% CI 0.33-0.94), and in Southern Italy students are more likely to advise physical methods (OR 1.77, 95% CI 1.22-2.57) and less likely to believe that fever has mainly beneficial effects (OR 0.55, 95% CI 0.39-0.77). History of a relevant personal episode of fever during childhood was not associated with these outcomes. CONCLUSIONS: Misconceptions about fever are common among final-year medical students in Italy. Cultural factors rather than individually learned traits might underlie these beliefs. Medical students are a promising target for educational interventions to improve childhood fever management.

Childhood fever and medical students: A multicentre, educational intervention.

AIM: Misconceptions and non-evidence-based practices toward childhood fever are reported worldwide. Medical students might be ideal candidates to introduce long-lasting changes in clinical practice. However, no study has gauged the effectiveness of an educational intervention to improve fever management in this population. We conducted an educational, interventional study on childhood fever among final-year medical students. METHODS: We conducted a prospective, multicentre interventional study employing a pre/post-test design. Participants from three Italian Universities filled in a questionnaire just before the intervention (T0), immediately after (T1) and 6 months later (T2) in 2022. The intervention was a two-hour lecture focused on the pathophysiology of fever, recommendations for its treatment and risks associated with improper management. RESULTS: 188 final-year medical students (median age of 26 years, 67% females) were enrolled. Relevant improvements in the criterion for treating fever and conceptions about the beneficial effects of fever were observed at T1 and T2. Similar data were found for the reduction of physical methods advice to decrease body temperature and concerns for brain damage from fever. CONCLUSION: This study shows for the first time that an educational intervention is effective in changing students' conceptions and attitudes toward fever both in the short and medium term.

The hidden universe of human milk microbiome: origin, composition, determinants, role, and future perspectives.

Although traditionally considered sterile, human milk is currently recognized as an alive ecosystem that harbors not only bacteria, but also viruses, fungi and yeasts, and minor genera, collectively known as the human milk microbiome (HMM). The seeding of HMM is a complex phenomenon whose dynamics are still a matter of research. Many factors contribute to its determination, both maternal, neonatal, environmental, and related to human milk itself. The transmission of microorganisms to the infant through breastfeeding may impact its present and future health, mainly shaping the GI tract microbiome and immune system. The existence and persistence of HMM as a conserved feature among different species may also have an evolutionary meaning, which will become apparent only in evolutionary times. CONCLUSION: The complexities of HMM warrant further research in order to deepen our knowledge on its origin, determinants, and impact on infants' health. The practical and translational implications of research on HMM (e.g., reconstitution of donor human milk through inoculation of infant's own mother milk, modulation of HMM through maternal dietary supplementation) should not be overlooked. WHAT IS KNOWN: • Human milk harbors a wide variety of microorganisms, ranging from bacteria to viruses, fungi and yeasts, and minor genera. • Human milk microbiome is shaped over time by many factors: maternal, neonatal, environmental, and related to human milk itself. • The transmission of microorganisms through breastfeeding may impact the infant's present and future health. WHAT IS NEW: • We provide an overview on human milk microbiome, hopefully encouraging physicians to consider it among the other better-known breastfeeding benefits. • Further studies, with standardized and rigorous study designs to enhance accuracy and reproducibility of the results, are needed to deepen our knowledge of the human milk microbiota and its role in newborn and infant's health.

Breastfeeding during a Pandemic.

BACKGROUND: The current pandemic and the concerns of vertical transmission of SARS-CoV-2 have contributed to increasing the rate of breastfeeding interruption. This tendency has been associated with negative effects on the well-being of lactating mothers and their infants. The aim of this review is to summarize the evidence on the strategies to support breastfeeding during the COVID-19 pandemic and on the safety of breastfeeding during a SARS-CoV-2 infection or after COVID-19 vaccination. SUMMARY: Available data show that the lack of support of lactating mothers during the pandemic has contributed to breastfeeding cessation worldwide. However, a few strategies have been proposed to overcome this issue. The risk of SARS-CoV-2 transmission from infected mothers to their offspring is extremely low. Furthermore, vaccination of lactating mothers is not associated with side effects in their infants. Key Messages: Increasing effort should be made to support breastfeeding during the COVID-19 pandemic. Mothers who are able to take care of their offspring and to adopt basic hygiene measures should not interrupt breastfeeding during a SARS-CoV-2 infection. Vaccination of lactating mothers might further strengthen the protective effect of breastfeeding against infections.

From dyad to triad: a survey on fathers' knowledge and attitudes toward breastfeeding.

Fathers are known to impact breastfeeding outcomes. We aimed to explore paternal knowledge and attitude toward breastfeeding, and possible association with breastfeeding rates at discharge. In this cross-sectional study, we enrolled 200 fathers of healthy term neonates. At discharge, fathers were asked to rate their degree of agreement to 12 items on a 5-point Likert scale. A total score was obtained from their answers. Univariate binary logistic regression analysis was used to verify if the total score was predictive of exclusive breastfeeding at discharge. A multivariable logistic regression model was then used to adjust for possible confounders. ROC analysis was performed, and a Youden's total score cut-off value was determined to define total score's performance in predicting exclusive breastfeeding at discharge. Fathers showed a solid knowledge of maternal (87%) and neonatal (98%) benefits of breastfeeding, skin-to-skin (99.5%), rooming-in (79%), and responsive feeding (67.5%); conversely, only 51% knew about the recommended use of pacifiers. Fathers felt personally involved in babies' feeding in 79% of cases. An association was found between total score and exclusive breastfeeding at discharge at univariate (OR: 1.07, p = 0.04) but not at multivariable analysis (OR: 1.07, p = 0.067). ROC analysis was not statistically significant (AUC 0.58, p = 0.083).Conclusion: By using a novel instrument aimed at quantifying fathers' knowledge and overall attitude toward breastfeeding, this study underlines the importance of including fathers in the promotion of breastfeeding. Expanding the classic mother-baby dyad to a more modern mother-father-baby triad may impact breastfeeding outcomes at discharge. What is known: • Social support plays a major role in improving breastfeeding outcomes. • Fathers may greatly influence initiation and duration of breastfeeding; the more they know, the more helpful they can be. What is new: • A multidisciplinary team created a structured questionnaire aimed at quantifying fathers' knowledge and attitude toward breastfeeding. • The association between a higher questionnaire total score and exclusive breastfeeding rates at discharge highlights the importance of including fathers in the promotion of breastfeeding, as part of the breastfeeding team.

Nurses in Family Pediatric Practices: A Survey of the Health Protection Agency of the Metropolitan City of Milan.

PURPOSE: Primary pediatric care in Italy is guaranteed by family pediatricians, who may have their own private offices or work in group clinics that also have nurses/pediatric nurses in order to enrich their offer of services. The aim of this study was to investigate the activities of nurses working in pediatric practices in order to identify and classify the nursing healthcare services offered by the practices themselves. DESIGN AND STUDY: An observational study was conducted including nurses working in the pediatricians' offices who voluntarily agreed to undergo a semi-structured interview. The investigated variables were individual, institutional and organizational. The study sample consisted of 22 nurses with a mean age of 39 ± 13.3 years, 16 of whom were pediatric nurses. RESULTS: All of the nurses stated that they had not received suitable training for working outside a hospital, and that they carried out educational, diagnostic/therapeutic, and bureaucratic administrative/support activities. Nine of the nurses working in group pediatric clinics carried out educational activities autonomously, something that the nurses working in individual or associated clinics did not perform. Twenty of the interviewees also provided telephone consultancy, and 11 of the clinics used algorithms as guides. CONCLUSIONS/PRACTICE IMPLICATIONS: The findings of this study underline the potential of developing the nursing profession at community level. Further studies are desirable in order to extend the investigation of the pediatric nurses' activities implemented at community level in other Italian provinces.

Knowledge and attitude of health staff towards breastfeeding in NICU setting: are we there yet? An Italian survey.

The benefits of human milk in preterm infants, a population at high risk for developing adverse outcomes for which breast milk is a protective factor, are widely acknowledged. However, preterms' admission in a neonatal intensive care unit (NICU) and newborn's clinical conditions have been described as significant barriers, leading to lower rates of breastfeeding initiation and duration. Healthcare workers play a crucial role in encouraging breastfeeding. We conducted a cross-sectional survey among nurses working in six Italian NICUs, exploring their knowledge and attitude towards breastfeeding. Although the majority of nurses had a specific breastfeeding education, our results show still some variations among answers regarding aspects of breastfeeding support in this setting. Specifically, family-centered care, transition feeding to the breast, and skin-to-skin practice, despite being extensively addressed by the Neo Baby-Friendly Hospital Initiative, are the items that highlighted a range of answers that could result in conflicting information to mothers.Conclusion: By underlining the gaps of knowledge and attitude towards breastfeeding of nurses working in NICUs, this study provides an insight into what needs to be improved, with the aim of promoting higher rates of breastfeeding in the preterm population. What is Known: • Breastfeeding is particularly challenging in the preterm population, despite its universally recognized health benefits. • Improving healthcare professionals' knowledge and attitude towards breastfeeding has been shown to be crucial for promoting breastfeeding in NICUs. What is New: • Our results provide useful insight into nurses' knowledge and attitude towards breastfeeding in NICU settings. • By acknowledging strengths and weaknesses highlighted by this study, tailored strategies could be developed to improve health staff breastfeeding education and support to parents in NICU settings.

Can Postbiotics Represent a New Strategy for NEC?

Increasing evidence indicates that many of the health beneficial effects associated with the establishment of a symbiotic gut microbiota are driven by bacterial metabolic by-products.The term "postbiotics" indicates any soluble factor resulting from the metabolic activity of a live bacteria or any released molecule capable of providing health benefits through a direct or indirect mechanism.Alterations in preterm gut colonization associated with the intestinal barrier immaturity and the increased reactivity of the intestinal mucosa to colonizing bacteria have been implicated in the pathogenesis of necrotizing enterocolitis. Recent advances in the comprehension of the postbiotic biological effects and related mechanisms, some of them reviewed here, indicate that postbiotics may be a promising effective preventive strategy against necrotizing enterocolitis while avoiding the risk of administering live microorganisms to preterm infants that could translocate and cause infection. However, data from trials investigating the efficacy of postbiotics for the prevention of necrotizing enterocolitis in preterm infants are needed, and issues regarding their optimal regimen and start and duration of treatment need to be addressed.

Correction to: Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.

Following the publication of the original article [1], it was brought to our attention that the authors' names and surnames were erroneously interchanged.

Maternal views on facilitators of and barriers to breastfeeding preterm infants.

BACKGROUND: The supply of breast milk to preterm infants tends to occur at a lower rate than that recorded among term infants. We aimed to investigate the facilitators of and barriers to breastfeeding during hospital stay according to the experiences of mothers that gave birth to premature infants requiring admission to neonatal intensive care unit. METHODS: A cross-sectional questionnaire survey was conducted. Mothers who had delivered a newborn with a gestational age ≤33 weeks requiring intensive care, entered the study. Basic subjects' characteristics and infant feeding practices were also recorded. RESULTS: A total of 64 mothers were enrolled, leading to a total of 81 infants. At discharge, any breastfeeding was recorded in 66% of infants, with 27% of those infants being exclusively breastfed. Any infant was exclusively fed directly at the breast. Most mothers experienced adequate support during their infant's hospitalization and reported satisfaction with breastfeeding. Almost all mothers felt that feeding their infant human milk was beneficial for the infant's health. Thirty percent of the mothers reported that they had experienced some obstacles to breastfeeding. Specifically, infants born to mothers who experienced difficulties in pumping breast milk (OR = 4.6; CI 1.5-13.9) or in providing an adequate amount of milk to the infant (OR = 3.57; CI 1.1-11.5) were at higher risk of being fed with formula at discharge. CONCLUSIONS: On the basis of the present results, health care professionals should target their efforts to optimize breastfeeding support for mothers of premature infants admitted to level III care, especially by improving breast milk production and endorsing direct breastfeeding.

An infant formula containing dairy lipids increased red blood cell membrane Omega 3 fatty acids in 4 month-old healthy newborns: a randomized controlled trial.

BACKGROUND: When breastfeeding is not possible, infants are fed formulas (IF) in which lipids are usually of plant origin. However, the use of dairy fat in combination with plant oils enables a lipid profile closer to breast milk in terms of fatty acid (FA) composition, triglyceride structure, polar lipids and cholesterol contents. The objective of this study was to determine the effect of an IF containing a mix of dairy fat and plant oils on Omega-3 FA content in red blood cells (RBC). METHODS: This study was a monocentric, double-blind, controlled, randomized trial. Healthy term infants were fed formulas containing a mix of dairy fat and plant oils (D), plant oils (P) or plant oils supplemented with ARA and DHA (PDHA). Breastfed infants were enrolled as a reference group (BF). FA in RBC phosphatidylethanolamine was evaluated after 4 months and FA in whole blood were evaluated at enrollment and after 4 months by gas chromatography. Differences between groups were assessed using an analysis of covariance with sex and gestational age as covariates. RESULTS: Seventy IF-fed and nineteen BF infants completed the protocol. At 4 months, RBC total Omega-3 FA levels in infants fed formula D were significantly higher than in group P and similar to those in groups PDHA and BF. RBC DHA levels in group D were also higher than in group P but lower than in groups PDHA and BF. RBC n-3 DPA levels in group D were higher than in groups P, PDHA and BF. A decrease in proportions of Omega-3 FA in whole blood was observed in all groups. CONCLUSIONS: A formula containing a mix of dairy lipids and plant oils increased the endogenous conversion of Omega-3 long-chain FA from precursor, leading to higher total Omega-3, DPA and DHA status in RBC than a plant oil-based formula. Modifying lipid quality in IF by adding dairy lipids should be considered as an interesting method to improve Omega-3 FA status. TRIAL REGISTRATION: Identifier NCT01611649 , retrospectively registered on May 25, 2012.

No effect of adding dairy lipids or long chain polyunsaturated fatty acids on formula tolerance and growth in full term infants: a randomized controlled trial.

BACKGROUND: When breastfeeding is not possible, infants are fed formulas in which lipids are usually of plant origin. However, the use of dairy fat in combination with plant oils enables a lipid profile in formula closer to breast milk in terms of fatty acid composition, triglyceride structure and cholesterol content. The objectives of this study were to investigate the impact on growth and gastrointestinal tolerance of a formula containing a mix of dairy lipids and plant oils in healthy infants. METHODS: This study was a monocentric, double-blind, controlled, randomized trial. Healthy term infants aged less than 3 weeks whose mothers did not breastfeed were randomly allocated to formula containing either: a mix of plant oils and dairy fat (D), only plant oils (P) or plant oils supplemented with long-chain polyunsaturated fatty acids (PDHA). Breastfed infants were included in a reference group (BF). Anthropometric parameters and body composition were measured after 2 and 4 months. Gastrointestinal tolerance was evaluated during 2 day-periods after 1 and 3 months thanks to descriptive parameters reported by parents. Nonrandomized BF infants were not included in the statistical analysis. RESULTS: Eighty eight formula-fed and 29 BF infants were enrolled. Gains of weight, recumbent length, cranial circumference and fat mass were similar between the 3 formula-fed groups at 2 and 4 months and close to those of BF. Z-scores for weight, recumbent length and cranial circumference in all groups were within normal ranges for growth standards. No significant differences were noted among the 3 formula groups in gastrointestinal parameters (stool frequency/consistency/color), occurrence of gastrointestinal symptoms (abdominal pain, flatulence, regurgitation) or infant's behavior. CONCLUSIONS: A formula containing a mix of dairy lipids and plant oils enables a normal growth in healthy newborns. This formula is well tolerated and does not lead to abnormal gastrointestinal symptoms. Consequently, reintroduction of dairy lipids could represent an interesting strategy to improve lipid quality in infant formulas. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01611649 , retrospectively registered on May 25, 2012.

Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.

BACKGROUND: A high early protein intake is associated with rapid postnatal weight gain and altered body composition. We aimed to evaluate the safety of a low-protein formula in healthy full-term infants. METHODS: A randomized controlled trial was conducted. A total of 118 infants were randomized to receive two different protein content formulas (formula A or formula B (protein content: 1.2 vs. 1.7 g/100 mL, respectively)) for the first 4 months of life. Anthropometry and body composition by air displacement plethysmography were assessed at enrolment and at two and 4 months. The reference group comprised 50 healthy, exclusively breastfed, full-term infants. RESULTS: Weight gain (g/day) throughout the study was similar between the formula groups (32.5 ± 6.1 vs. 32.8 ± 6.8) and in the reference group (30.4 ± 5.4). The formula groups showed similar body composition but a different fat-free mass content from breastfed infants at two and 4 months. However, the formula A group showed a fat-free mass increase more similar to that of the breastfed infants. The occurrence of gastrointestinal symptoms or adverse events was similar between the formula groups. CONCLUSIONS: Feeding a low-protein content formula appears to be safe and to promote adequate growth, although determination of the long-term effect on body composition requires further study. TRIAL REGISTRATION: The present study was retrospectively registered in ClinicalTrials.gov (trial number: NCT03035721 on January 18, 2017).