Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Pre-, and Postbiotics: A Multi-Country Multi-Center Prospective Randomized Controlled Study in Infants with Regurgitation.

This multi-center prospective randomized controlled trial was a tolerance and safety study investigating the thickener locust bean gum (LBG) in infants with regurgitation, to support the re-evaluation of the safety of LBG in infant formula. The primary objective was to demonstrate that after an 8-week intervention, stool consistency was not inferior (i.e., was not looser or more watery) in infants fed an anti-regurgitation (AR) formula containing LBG vs. the stool consistency of infants fed with an unthickened control formula. A total of 103 full-term infants with regurgitation were randomized to the test or control formula. The test formula contained LBG (0.4 g/100 mL), short-chain galacto-oligosaccharides, and long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1; 0.4 g/100 mL) and postbiotics and the control formula contained scGOS/lcFOS (0.8 g/100 mL), the same amount of postbiotics, and did not contain LBG. The average stool consistency score at the 8th intervention week was the primary outcome parameter. Secondary outcome parameters were stool consistency at other timepoints, stool frequency, Infant Gastrointestinal Symptom Questionnaire (IGSQ) score, growth, (serious) adverse events ([S]AEs), regurgitation severity, and infant well-being. Overall, the infants were 36.9 ± 12.9 [mean ± SD] days old, 62.7% girls in the test, and 50.0% girls in the control group. The primary analysis showed that the test group did not have looser or more watery stools than the control group. IGSQ sum scores decreased comparably in both groups. The frequency of regurgitation was significantly lower in the test group compared to the control group (mixed model repeated measurement, p ≤ 0.028) and parent-reported well-being scores were favorable. Adequate growth was observed in both groups. Both products were well-tolerated and safe and the AR formula with LBG was efficacious in reducing regurgitation frequency. This study provides further evidence for the dietary management of regurgitation by LBG-containing formulae in infants who are not exclusively breastfed, and the reassurance it can bring to parents.

[Assessment of somatic development and body composition in the 7th year of life in children born as extremely low birth weight infants (≤1000g); a multi-centre cross-sectional study of a cohort born between 2002 and 2004 in the Malopolska voivodship]. / Ocena rozwoju somatycznego i skladu ciala dzieci w 7. roku zycia urodzonych z ekstremalnie mala masa ciala (≤1000 g)--wieloosrodkowe badanie przekrojowe kohorty urodzonej w latach 2002-2004 w województwie malopolskim.

UNLABELLED: Children born with extremely low birth weight often present delayed growth in the first years of their lives: they remain shorter and weigh less than their peers. Current reports published worldwide state that later in life these children are at an increased risk of cardiac and vascular diseases, diabetes and obesity. Abnormal distribution and the excess of fat tissue predispose them to develop the metabolic syndrome. THE AIM of the study was to evaluate the somatic development of seven-year-old children born with birth-weight ≤1000 g (ELBW) in the Malopolska voivodship and to estimate the content and distribution of fat tissue. Moreover, the risk factors of disturbed somatic development were evaluated. MATERIALS AND METHODS: Two hundred and four live newborns with birth weight ≤1000 g were born in the Malopolska voivodship between 1.09.2002 and 31.08.2004. One hundred and fifteen of these children (56%) died in early infancy. The study included 81 children in the 7th year of life out of the 89 surviving ones. Their mean gestational age at birth was 27.3 weeks. (SD: 2.1 weeks) and their mean birth-weight was 840 g (SD: 130 g). All the children underwent anthropometric measurements and the thickness of the skin fold over the triceps was measured. Body mass index (BMI) was calculated and the body composition was assessed by multifrequency bioimpedance. The control group consisted of 39 children born at term chosen randomly from the general population and matched with regard to age and sex. RESULTS: The ELBW children in the 7th year of life were shorter (z-score: -1.06±1.4 p<0.001), had lower body mass (z-score: -0.57±0.9; p=0.01), smaller head circumference (z-score: -1.2±1.3; p<0.001), lower BMI (z-score: -0.99±1.6; p<0.001) as compared to their peers. Fat tissue mass was lower in the ELBW group than in the control group (11% vs 16%; p<0.01). The most retarded somatic development was observed in the group of children suffering from cerebral palsy. CONCLUSIONS: 1. Children born with ELBW, at 7 years of life, present significantly retarded somatic development as compared with their full-term peers. 2. The most important risk factor of somatic development disturbances is cerebral palsy. 3. Children born with low birth weight and ELBW, need long term follow up.

[Intellectual and motor development of extremely low birth weight (≤1000 g) children in the 7th year of life; a multicenter, cross-sectional study of children born in the Malopolska voivodship between 2002 and 2004]. / Rozwoj poznawcyz i motoryczny w 7 roku zycia dzieci urodzonych z ekstremalnie mala masa ciala (≤1000 G) - wieloosrodkowe badanie przekrojowe dzieci urodzonych w latach 2002-2004 w wojewodztwie malopolskim.

INTRODUCTION: A better understanding of the developmental problems in extremely low birth weight (ELBW) preterm infants may enhance their chances of proper adaptation to their environment and make it possible to retrospectively assess perinatal and neonatal methods of treatment. The aim of the study was to evaluate the cognitive and motor development of ELBW children born from 2002 to 2004 in the 7th year of life. Based on these results and perinatal mortality data, it was established what chance the children have to live free of severe complications. MATERIAL AND METHODS: Two hundred and four alive newborns with birth weight .1000 g were born in the Malopolska voivodship between 1.09.2002 and 31.08.2004. One hundred and fifteen children (56%) died in early infancy. The study included 81 (91%) children out of the 89 surviving ones. Their mean gestational age at birth was 27.3 weeks. (SD: 2.1 weeks) and their mean birth weight was 840g (SD: 130g). Neurosensory disturbances were assessed in all the children and their cognitive development was evaluated with the use of the WISC-R (Wechsler Intelligence Scale for Children . Revised) scale. The children were divided into 3 groups: group I . normal development (full motor capacity and IQ >84 points and no vision or hearing impairment), group II . mild or moderate impairment (cerebral palsy level I, II or III according to the Gross Motor Function Classification System [GMCS], or IQ 40-84 points, or abnormal vision or hearing, or signs of the hyperactivity syndrome), group III . severe impairment (cerebral palsy level IV, and/or IQ <40 points, or deafness/blindness). RESULTS: Forty-five (56%) children were included in group I, 25 (30%) in group II and 11 (14%) in group III. Moreover, other neurologic abnormalities, such as uneven development, problems with concentration, or abnormal grapho-motor ability were highly prevalent in the group of ELBW children. The incidence of cerebral palsy in the population studied was 16%, the incidence of deafness and severe hearing impairment was 11%, and blindness and severe vision impairment . 12%. In general, the chance of survival free of severe complications was merely 15% in children with birthweight .700 g, 28% in children with birth weight 701- 800 g, 45% in children with birth weight 801-900 g, and 62% in children with birth weight 901-1000 g. CONCLUSIONS: 1. The data gathered in a regional study may yield valuable information useful in assessing the prognosis of the general health status of ELBW newborns. 2. Most of the children present uneven development, problems with concentration, or abnormal grapho-motor ability, which may be a cause of learning problems and abnormal relationships with peers. 3. A follow-up study up to adulthood is required for this group of ELBW newborns.

[Measurement of the passive compliance of the total respiratory system in newborn after respiratory insufficiency for risk assessment of respiratory disorders during the first 6 month of life]. / Pomiar podatnosci ukladu oddechowego u noworodków po przebyciu niewydolnosci oddechowej w ocenie ryzyka wystapienia zaburzen oddechowych w pierwszych 6 miesiacach zycia.

AIMS: To evaluate the relationships between postnatal passive respiratory compliance (Crs) and development of respiratory disorders during the first 6 month of life in preterm and full-term infants after respiratory insufficiency. The purpose of this study was to investigate whether other relevant neonatal factors, like degree of prematurity, birth weigh, ventilatory conditions, sepsis, and respiratory disease severity affected this relationship. MATERIAL AND METHODS: The passive respiratory compliance was measured by the single occlusion technique in 73 preterm infants after respiratory distress syndrome (RDS), 19 full-term infants after congenital pneumonia and 33 healthy full-term infants. Respiratory function measurements were performed by single occlusion technique, during natural sleep, after acute phase of illness, before discharge from neonatal department. RESULTS: Crs was significantly lower in premature newborns < 36 weeks gestation after RDS (p = 0.0002) and in term newborns who have suffered from a congenital pneumonia (p = 0.0411), than in healthy full-term newborn infants. Premature infants who have undergone sepsis have significantly decreased Crs in relationship with those who did not have this complication (p = 0.0334). Preterm newborns who have suffered pneumonia during treatment of RDS have significantly frequent respiratory problems during the first 6 month of age (p = 0.043). Full-term infants after congenital pneumonia have more but not significantly frequent respiratory problems than healthy term newborns (p = 0.055) in this period. Decreased neonatal Crs wasn't significantly related to respiratory disorders in age of 6 month of life. CONCLUSION: Prematurity under 36 week of gestational age, low birth weight and suffering from sepsis in premature infants significantly decreased Crs in newborn. Decreased neonatal Crs in premature and full term infants after respiratory insufficiency wasn't significantly related to respiratory disorders during first 6 month of life. This study has showed significantly increase of respiratory problems in this period in preterm infants who have suffered from pneumonia during neonatal period.

[Prevalence and risk factors of bronchopulmonary dysplasia among extremely low birth weight newborns of regional birth cohort of south-east Poland]. / Wystepowanie i czynniki ryzyka dysplazji oskrzelowo-plucnej u noworodków urodzonych w województwie malopolskim z ekstremalnie mala masa ciala (< or =1000g).

BACKGROUND: Advances in intensive health care within the last 30 years have resulted in increased survival of most immature neonates. The results of epidemiological studies indicate, however, that late complications of prematurity, including bronchopulmonary dysplasia (BPD), have become more frequent since the late 1990s. The identification of risk factors predisposing to severe BPD might help in developing treatment methods directed at the group of children with high risk of developing the disease. AIM: Analysis of prevalence and risk factors of bronchopulmonary dysplasia among extremely low birth weight newborns of regional birth cohort of south-east Poland. METHODS: The study included newborns of birth weight < or = 1000g born in south-east district of Poland within one calendar year. The data assessed were: the need of oxygen therapy of at least 28 days' duration and the need of oxygen therapy at 36 weeks of postmenstrual age (PMA). RESULTS: During the study period 109 newborns with birth weight < or = 1000g) were hospitalized in three third-level departments of neonatology in south-east Poland. The final assessment for BPD included 56 children (51%), whose mean birth weight was 839g (SD: 128) and mean gestational age was 27.3 weeks (SD: 2.2). Thirty-nine children (70%) required oxygen therapy for at least 28 days, and 27 children (48%) required oxygen therapy at 36 weeks of PMA. Gestational age of the newborn, the need of respiratory support at birth, and the need of surgical treatment of PDA were found to be independent risk factors of oxygen therapy lasting for at least 28 days. Only the need of respiratory support at 7 days of life and the need for surgical treatment of PDA were found to be independent risk factors of oxygen therapy at the 36 weeks of PMA. CONCLUSION: The analysis of several risk factors of BPD in children with birth weight < or =1000g revealed that the need for respiratory support at seven days of life is a major risk factor of developing chronic respiratory disease. The risk of BPD may be significantly reduced by adequate care aimed at shortening the time of conventional respiratory support and at limiting the persistence of ductus arteriosus.