scholarly journals Acceptability of “High sn-2” Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician: An Open-Label Pilot Study in the Gulf Cooperation Council (GCC) Countries

2021 ◽  
Vol 13 (4) ◽  
pp. 639-649
Author(s):  
Mike Possner ◽  
Ibrahim El-Neklaway ◽  
Mohamed Khater ◽  
Mohamed Fikry ◽  
Abdeldaem Nazem Alshahoud ◽  
...  

Recent studies have highlighted the positive impact of high sn-2 formulas on gastrointestinal (GI) tolerance. We assessed the GI tolerance, acceptability, and safety of high sn-2 infant formula among non-breastfed healthy term infants in the Gulf countries. A multicenter observational study was conducted on 227 healthy-term infants who were prescribed high sn-2 palmitate infant formula and received a minimum of two formula feedings per day for the past two weeks prior to the study’s initiation. The number of stools per day decreased significantly from a median of four (interquartile range [IQR] = 4) at baseline to 3.0 (2) stools per day at the end of follow-up (p = 0.015). The percentage of stool amount changed significantly, where 61.2% and 33.7% of the infants had an amount of 25–50% of the diaper and >50% of the diaper, respectively (p < 0.001) at the end of the follow-up. Similarly, the percentage of hard stool decreased significantly from 17.4% at baseline to 0.4% of the population at week 12 (p < 0.00). The prevalence of colic and abdominal distention declined from 21.4% and 39.9% at baseline to 2.9% and 9.4% at week 12, respectively (p < 0.05). The same decline was observed in abdominal distension and regurgitation score (p < 0.05).

PEDIATRICS ◽  
1995 ◽  
Vol 96 (4) ◽  
pp. 730-733 ◽  
Author(s):  
M. Jeffrey Maisels ◽  
Thomas B. Newman

Objective. To document the occurrence of classical kernicterus in full-term, otherwise healthy, breast-fed infants. Methods. We reviewed the files of 22 cases referred to us by attorneys throughout the United States during a period of 18 years, in which neonatal hyperbilirubinemia was alleged to be responsible for brain damage in apparently healthy, nonimmunized, full-term infants. To qualify for inclusion, these infants had to be born at 37 or more weeks' gestation, manifest the classic signs of acute bilirubin encephalopathy, and have the typical neurologic sequelae. Results. Six infants, born between 1979 and 1991, met the criteria for inclusion. Their peak recorded bilirubin levels occurred 4 to 10 days after birth and ranged from 39.0 to 49.7 mg/dL. All had one or more exchange transfusions. One infant had an elevated reticulocyte count (9%) but no other evidence of hemolysis. The other infants had no evidence of hemolysis, and no cause was found for the hyperbilirubinemia (other than breast-feeding). Conclusions. Although very rare, classic kernicterus can occur in apparently healthy, full-term, breast-fed newborns who do not have hemolytic disease or any other discernible cause for their jaundice. Such extreme elevations of bilirubin are rare, and we do not know how often infants with similar serum bilirubin levels escape harm. We also have no reliable method for identifying these infants early in the neonatal period. Closer follow-up after birth and discharge from the hospital might have prevented some of these outcomes, but rare, sporadic cases of kernicterus might not be preventable unless we adopt an approach to follow-up and surveillance of the newborn that is significantly more rigorous than has been practiced. The feasibility, risks, costs, and benefits of this type of intervention need to be determined.


2015 ◽  
Vol 9 ◽  
pp. CMPed.S17841
Author(s):  
Hugo Da Costa Ribeiro Júnior ◽  
Tereza Cristina Medrado Ribeiro ◽  
Angela Peixoto De Mattos ◽  
Mariana Pontes ◽  
Roseli Oselka Saccardo Sarni ◽  
...  

Objective The aim of the current study was to evaluate the safety of a new reduced protein (2.1 g/100 kcal) infant formula containing 4 g/L of 90% galacto-oligosaccharides (GOS) and 10% fructo-oligosaccharides (FOS). Methods Healthy term infants from Brazil were enrolled. Those born to human immunodeficiency virus (HIV)-positive mothers were randomized to a test ( n = 65) or control ( n = 63) formula group. Infants born to HIV-negative mothers were either exclusively breast-fed ( n = 79) or received a mixed diet (breast milk and test formula, n = 65). Between 2 weeks and 4 months of age, infants were exclusively fed according to their assigned group. Anthropometric measurements were taken at baseline, 1, 2, 3, 4, 6, 8, 10, and 12 months. Digestive tolerance was evaluated during the first 4 months. The primary outcome was mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups. Results Data from all infants ( N = 272) were used in the intention-to-treat (ITT) analysis and data from 230 infants were used in the per-protocol (PP) analysis. The difference in mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups was 1.257 g/day (onesided 95% confidence interval [CI]: -0.705 to inf, P < 0.001) in the PP analysis, showing that the lower bound of the 95% CI was above the -3.0 g/day non-inferiority margin. Results were similar in the ITT analysis. Symptoms of digestive tolerance and frequency of adverse events were similar in the two groups. Conclusions The formula containing 2.1 g/100 kcal protein and GOS and FOS was safe and tolerated well.


PEDIATRICS ◽  
1995 ◽  
Vol 96 (4) ◽  
pp. 727-729 ◽  
Author(s):  
Daniel S. Seidman ◽  
David K. Stevenson ◽  
Zivanit Ergaz ◽  
Rena Gale

Severe neonatal hyperbilirubinemia can occur without apparent reason in term healthy breast-fed infants and some develop kernicterus. The aim of our study was to assess the incidence of severe hyperbilirubinemia in term healthy newborns discharged from the hospital. From January 1 through December 31, 1994, 6705 infants were delivered at Bikur-Cholim and Misgav-Ladach Community Hospitals. All 1448 newborns discharged with a serum bilirubin level &gt;10.0 mg/dL were instructed to return to the hospital within 3 days for follow-up, as well as bilirubin determination. Twenty-one newborns with a bilirubin level &gt;18.0 mg/dL were identified and readmitted at mean ± standard deviation (SD) 5.5 ± 1.8 (range, 5 to 10 days of life). This represents 1.7% of the 1220 infants who returned for follow-up examination. Mean ± SD serum bilirubin levels at readmission were 19.6 ± 2.5 mg/dL. All but one of the infants were breast-fed. No cases of ABO incompatibility were found and two newborns were glucose-6-phosphate dehydrogenase (G6PD)-deficient. Sepsis work-up and direct Coomb's tests were negative in all cases. None had hemolysis or were found to have any cause for hyperbilirubinemia other than breast-feeding. Phototherapy was provided in all but two cases, and an exchange transfusion was performed in one case. Three additional infants, with bilirubin levels &lt;10 mg/dL at discharge, were readmitted due to hyperbilirubinemia. One was diagnosed with neonatal hepatitis. We conclude that, based on our study population, 0.36% of term infants may subsequently develop severe neonatal hyperbilirubinemia in the first postnatal week. Adequate follow-up programs should be available when early discharge of healthy term newborns is considered.


1998 ◽  
Vol 43 ◽  
pp. 217-217 ◽  
Author(s):  
Mary C Harris ◽  
Judy C Bernbaum ◽  
Jessica R Polin ◽  
Richard A Polin

2021 ◽  
Vol 50 (1) ◽  
pp. 33-41
Author(s):  
M. Krpan ◽  
N. Major ◽  
Z. Šatalić ◽  
M. Hruškar

AbstractHuman breast milk, infant formula, and follow-up milks were tested by a commercial electronic tongue (αAstree, Alpha MOS) with the aim to determine taste diversity, since it has been recently shown that infants exposed to different tastes early in life, develop different food preference at a later age. Human milk (36 samples) were obtained from 13 lactating women, while 12 samples of infant formula and 14 samples of follow-up milk were obtained from the Croatian market and opened prior to analysis. Human breast milk samples showed a much higher diversity than both infant formulae and follow-up milks. These results suggest that breast-fed infants are exposed to a broader sensory experience, while formula fed infants are exposed to less diverse taste. Future studies will probably answer how this influences later food choice, taste preferences, and consequently, risk of obesity and other chronic diseases.


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