Partially Hydrolysed Whey-Based Formulae with Reduced Protein Content Support Adequate Infant Growth and Are Well Tolerated: Results of a Randomised Controlled Trial in Healthy Term Infants.

The current study aimed to investigate growth, safety and tolerance of partially hydrolysed infant formulae in healthy full-term infants. Fully formula-fed infants were randomised ≤14 days of age to receive a partially hydrolysed whey formula with 2.27 g protein/100 kcal (pHF2.27) or the same formula with 1.8 g or 2.0 g protein/100 kcal (pHF1.8 and pHF2.0) until 4 months of age. The primary outcome was equivalence in daily weight gain within margins of ± 3 g/day; comparison with WHO Child Growth Standards; gastrointestinal tolerance parameters and number of (serious) adverse events were secondary outcomes. A total of 207 infants were randomised, and 61 (pHF1.8), 46 (pHF2.0) and 48 (pHF2.27) infants completed the study per protocol. Equivalence in daily weight gain was demonstrated for the comparison of pHF1.8 and pHF2.27, i.e., the estimated difference was -1.12 g/day (90% CI: [-2.72; 0.47]) but was inconclusive for the comparisons of pHF2.0 and pHF2.27 with a difference of -2.52 g/day (90% CI: [-4.23; -0.81]). All groups showed adequate infant growth in comparison with the World Health Organization (WHO) Child Growth Standards. To conclude, the evaluated partially hydrolysed formulae varying in protein content support adequate growth and are safe and well tolerated in healthy infants.

Effectiveness of rotavirus vaccination in prevention of hospital admissions for rotavirus gastroenteritis among young children in Belgium: case-control study.

OBJECTIVE: To evaluate the effectiveness of rotavirus vaccination among young children in Belgium. DESIGN: Prospective case-control study. SETTING: Random sample of 39 Belgian hospitals, February 2008 to June 2010. PARTICIPANTS: 215 children admitted to hospital with rotavirus gastroenteritis confirmed by polymerase chain reaction and 276 age and hospital matched controls. All children were of an eligible age to have received rotavirus vaccination (that is, born after 1 October 2006 and aged ≥ 14 weeks). MAIN OUTCOME MEASURE: Vaccination status of children admitted to hospital with rotavirus gastroenteritis and matched controls. RESULTS: 99 children (48%) admitted with rotavirus gastroenteritis and 244 (91%) controls had received at least one dose of any rotavirus vaccine (P<0.001). The monovalent rotavirus vaccine accounted for 92% (n=594) of all rotavirus vaccine doses. With hospital admission as the outcome, the unadjusted effectiveness of two doses of the monovalent rotavirus vaccine was 90% (95% confidence interval 81% to 95%) overall, 91% (75% to 97%) in children aged 3-11 months, and 90% (76% to 96%) in those aged ≥ 12 months. The G2P[4] genotype accounted for 52% of cases confirmed by polymerase chain reaction with eligible matched controls. Vaccine effectiveness was 85% (64% to 94%) against G2P[4] and 95% (78% to 99%) against G1P[8]. In 25% of cases confirmed by polymerase chain reaction with eligible matched controls, there was reported co-infection with adenovirus, astrovirus and/or norovirus. Vaccine effectiveness against co-infected cases was 86% (52% to 96%). Effectiveness of at least one dose of any rotavirus vaccine (intention to vaccinate analysis) was 91% (82% to 95%). CONCLUSIONS: Rotavirus vaccination is effective for the prevention of admission to hospital for rotavirus gastroenteritis among young children in Belgium, despite the high prevalence of G2P[4] and viral co-infection.

Reduction in pediatric rotavirus-related hospitalizations after universal rotavirus vaccination in Belgium.

BACKGROUND: This study investigated the effect of pediatric vaccination against rotavirus on the number of rotavirus-related hospitalizations of children in Belgium. METHODS: This retrospective database study was conducted at 12 pediatric hospitals in Belgium (546 pediatric beds, 30.6% of Belgian total). Children ≤ 5 years attending hospital for any reason were eligible if they had a rotavirus stool test at one of the study centers. The number of rotavirus-positive stool tests and hospitalizations for acute gastroenteritis (AGE) were compared for prevaccination (June 2004-May 2006) and postvaccination (June 2007-May 2009) study periods. RESULTS: The number of rotavirus-positive stool tests in children who were ≤ 5 years of age decreased from an average of 881 in the prevaccination period to 368 in the first year postvaccination period and 199 in the second. In children 2 to 24 months of age, the percentage reductions were 65% (95% confidence interval [CI]: 62%, 69%) and 80% (95% CI: 77%, 83%) in the first and second years after vaccination, respectively, compared with prevaccination. In children <2 months, the reductions were 50% (95% CI: 36%, 64%) and 64% (95% CI: 49%, 76%), respectively, and in children >24 months the corresponding values were 20% (95% CI: 14%, 28%) and 64% (95% CI: 56%, 72%). The number of AGE-driven hospital admissions and hospitalization days for AGE declined by 33% and 36%, respectively, from prevaccination to the second year postvaccination in children ≤ 2 years of age. CONCLUSIONS: Pediatric rotavirus vaccination in Belgium significantly reduced rotavirus-related hospitalizations in the first and second years after introduction.

Glass and antimony electrodes for oesophageal pH monitoring in distressed infants: how different are they?

OBJECTIVE: Although antimony electrodes are by far the most popular for performing oesophageal pH monitoring, there are few data comparing the accuracy of glass and antimony electrodes. Therefore, we tested the accuracy of both electrodes in the prediction of oesophagitis. METHOD: pH monitoring using a glass electrode and an antimony electrode was performed in 60 distressed infants, aged between 1 and 6 months. An upper endoscopy with oesophageal biopsies was also performed in all infants. RESULTS: A reflux index (percentage of the total time with pH < 4.0) greater than 5% was considered to be abnormal and was found in 40/60 patients. Histological oesophagitis was present in 26/60 infants. The reflux index was > 5% with the glass electrode in 18/26 children with histological oesophagitis and with the antimony electrode in 10/26 children with histological oesophagitis. Histology of the oesophagus was normal in 22/40 children with abnormal pH monitoring. With the glass electrode, the mean reflux index in the group with oesophagitis was significantly higher than in the group with normal histology, although there was an important overlap. With the antimony electrode, the mean reflux indices in the groups with and without oesophagitis were not different. Regarding normal/abnormal, there was discordance in 35% of the pH studies. No reflux index could be related to a clinically useful sensitivity and specificity to predict oesophagitis. CONCLUSION: The reflux index does not accurately predict oesophagitis. Oesophageal pH monitoring and endoscopy provide complementary information.

Oesophageal pH monitoring and reflux oesophagitis in irritable infants.

UNLABELLED: Acid reflux and/or oesophagitis may be responsible for inconsolable crying in infants. We evaluated prospectively the presence of acid reflux disease, oesophagitis and the accuracy of pH monitoring in the prediction of oesophagitis in a population of irritable infants. A 24-h oesophageal pH monitoring with a glass electrode and an upper gastro-intestinal tract endoscopy with grasp biopsies were performed in 60 irritable infants, aged 1 to 6 months, not responding to cow's milk elimination. The 24-h oesophageal pH monitoring was considered abnormal in 40/60 (66%) babies and histological oesophagitis was present in 26/60 (43%). In the infants with histological oesophagitis, the reflux index (% of the investigation time with a pH < 4.0) was > 5% in 18/26 (69%). Histology of the oesophagus was normal in 22 of the 40 (55%) infants with an abnormal pH monitoring. The mean reflux index in the group with oesophagitis (12.20%) was significantly higher than in the group with normal histology (8.74) (P = 0.036), although there was an important overlap. The sensitivity and specificity to predict oesophagitis with a reflux index of 5.0% or more was 69.2 and 35.3, respectively. There was not a reflux index which could be related to a clinically useful sensitivity and specificity to predict oesophagitis. CONCLUSION: Acid gastro-oesophageal reflux disease and/or histological oesophagitis were diagnosed in 66% and 43% of irritable infants, respectively. There was no relation between symptoms and abnormal pH metry or oesophagitis; however, the reflux index does not accurately predict oesophagitis and normal histology does not accurately exclude acid gastro-oesophageal reflux disease. Oesophageal pH monitoring and endoscopy provide additional information.