Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease

2014 ◽  
Vol 100 (1) ◽  
pp. 90-94 ◽  
Author(s):  
Facundo García-Bournissen ◽  
Samanta Moroni ◽  
Maria Elena Marson ◽  
Guillermo Moscatelli ◽  
Guido Mastrantonio ◽  
...  
Keyword(s):  
Breast Milk ◽  
Chagas Disease ◽  
High Performance ◽  
Adverse Drug Events ◽  
Disease Treatment ◽  
Lactating Women ◽  
Infant Exposure ◽  
Breastfed Infants ◽  
Link Type ◽  
Registration Number

BackgroundBenznidazole (BNZ) is safe and effective for the treatment of paediatric Chagas disease. Treatment of adults is also effective in many cases, but discouraged in breastfeeding women because no information on BNZ transfer into breast milk is available. We aimed to evaluate the degree of BNZ transfer into breast milk in lactating women with Chagas disease.Patients and methodsProspective cohort study of lactating women with Chagas disease treated with BNZ administered for 30 days. Patients and their breastfed infants were evaluated at admission, the 7th and 30th day of treatment (and monthly thereafter, for 6 months). BNZ was measured in plasma and milk by high performance liquid chromatography. The protocol was registered in ClinicalTrials.gov (#NCT01547533).Results12 lactating women with chronic Chagas disease were enrolled (median age 28.5 years, range 20–34). Median BNZ dose was 5.65 mg/kg/day twice daily. Five mothers had adverse drug events (45%), but no adverse drug reactions or any untoward outcomes were observed in the breastfed infants. Median milk BNZ concentration was 3.8 mg/L (range 0.3–5.9) and 6.26 mg/L (range 0.3–12.6) in plasma. Median BNZ milk to plasma ratio was 0.52 (range 0.3–2.79). Median relative BNZ dose received by the infant (assuming a daily breast milk intake of 150 mL/kg/day) was 12.3% of the maternal dose per kg (range 5.5%–17%).ConclusionsThe limited transference of BNZ into breast milk and the reassuring normal clinical evaluation of the breastfed babies suggest that maternal BNZ treatment for Chagas disease during breast feeding is unlikely to present a risk for the breastfed infant.Trial registration numberClinicalTrials.gov NCT01547533.

scholarly journals Revised Reference Values for Potassium Intake

2017 ◽  
Vol 71 (1-2) ◽  
pp. 118-124 ◽  
Author(s):  
Daniela Strohm ◽  
Sabine Ellinger ◽  
Eva Leschik-Bonnet ◽  
Friederike Maretzke ◽  
Helmut Heseker ◽  
...  
Keyword(s):  
Breast Milk ◽  
Children And Adolescents ◽  
Reference Values ◽  
Health Benefit ◽  
Reference Value ◽  
Potassium Excretion ◽  
Lactating Women ◽  
Potassium Intake ◽  
Breastfed Infants ◽  
Urinary Potassium

Background: The nutrition societies of Germany, Austria and Switzerland have revised the reference values for potassium intake in January 2017. Methods: For adults, the estimated value was based on the 24-h urinary potassium excretion and on preventive considerations regarding hypertension and stroke. The estimated values for children and adolescents were extrapolated from the adult estimated value considering differences in body mass. For infants aged 0 to under 4 months, the estimated value was set based on the potassium intake via breast milk. From this reference value, the estimated value for infants aged 4 to under 12 months was also derived by extrapolation. The estimated value for lactating women takes into account the potassium loss via breast milk. Results: The estimated values for potassium intake are set at 400 mg/day for breastfed infants aged 0 to under 4 months, 600 mg/day for infants aged 4 to under 12 months, 1,100-4,000 mg/day for children and adolescents, 4,000 mg/day for adults and pregnant women and 4,400 mg/day for lactating women. Conclusions: The consumption of potassium-rich foods should be generally increased. Supplemental intake beyond the estimated values has no health benefit and is therefore not recommended.

Emerging Research Paradigm for Infant Drug Exposure Through Breast Milk

2019 ◽  
Vol 25 (5) ◽  
pp. 528-533 ◽  
Author(s):  
Shinya Ito
Keyword(s):  
Risk Assessment ◽  
Breast Milk ◽  
Data Acquisition ◽  
Drug Exposure ◽  
Physiologically Based Pharmacokinetics ◽  
First Line ◽  
Lactating Women ◽  
Infant Exposure ◽  
Development Processes ◽  
Exposure Levels

Background: Information on drug secretion into milk is insufficient due to the exclusion of lactating women from clinical trials and drug development processes. As a result, non-adherence to the necessary drug therapy and discontinuation of breastfeeding occur, even if the predicted level of infant exposure is low. In contrast, inadvertent infant exposure to drugs in breast milk continues to happen due to lack of rational risk assessment, resulting in serious toxicity cases including death. This problem is multifactorial, but one of the key elements is the lack of pharmacokinetic information on drug secretion into milk and resultant infant exposure levels, the first line of evidence for risk assessment. Methods: Basic PK principles in drug excretion into milk were explained. The literature was scanned to identify approaches for PK data acquisition in this challenging field. Results: This review describes the feasibility to develop such approaches, and the knowledge gaps that still exist. A combination of population pharmacokinetics approach (to estimate averages and variations of drug concentration profiles in milk) and physiologically-based pharmacokinetics modeling of infants (to predict the population profiles of infant drug exposure levels) appears useful. Conclusions: In order to facilitate participant enrollment and PK data acquisition in a timely manner, networks of investigators become crucial.

scholarly journals Six Oligosaccharides’ Variation in Breast Milk: A Study in South China from 0 to 400 Days Postpartum

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 4017
Author(s):  
Shuang Liu ◽  
Xiaokun Cai ◽  
Jin Wang ◽  
Yingyi Mao ◽  
Yan Zou ◽  
...  
Keyword(s):  
Breast Milk ◽  
Early Life ◽  
High Performance ◽  
Anion Exchange Chromatography ◽  
Exchange Chromatography ◽  
Lactating Women ◽  
Time Points ◽  
Milk Samples ◽  
One Year ◽  
High Level

This study investigated the variation in oligosaccharide levels in the breast milk of south Chinese mothers in a prolonged breastfeeding period of up to 400 days postpartum. A total of 488 breast milk samples were collected from 335 healthy mothers at five different time points: 0–5 days, 10–15 days, 40–45 days, 200–240 days, and 300–400 days postpartum. A high-performance anion-exchange chromatography-pulsed amperometric detector (HPAEC-PAD) was used to quantify 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), 3′-sialyllactose (3′-SL) and 6′-sialyllactose (6′-SL). In this study, we found six oligosaccharides that were present in breast milk from 0 to 400 days postpartum. The median value ranges of individual oligosaccharide components in this study were 1013–2891 mg/L 2′-FL, 193–1421 mg/L 3-FL, 314–1478 mg/L LNT, 44–255 mg/L LNnT, 111–241 mg/L 3′-SL, and 23–602 mg/L6′-SL. HMO levels decreased over the lactation periods, except for 3-FL, which increased throughout lactation. The predominant fucosylated and sialylated HMOs were 2′-FL and 6′-SL at 40–45 days postpartum and changed to 3-FL and 3′-SL at 200–240 days postpartum. Results from this study showed that lactating women continue to provide their offspring with a high level of 2′-FL one year after delivery, suggesting that 2′-FL may play an important role for infants in early life. Our findings also provide further evidence in support of breastfeeding after one-year postpartum.

Determination of bisphenols and parabens in breast milk and dietary risk assessment for Polish breastfed infants

2021 ◽  
Vol 98 ◽  
pp. 103839
Author(s):  
Beata Czarczyńska-Goślińska ◽  
Tomasz Grześkowiak ◽  
Robert Frankowski ◽  
Janina Lulek ◽  
Jan Pieczak ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Breast Milk ◽  
Breastfed Infants ◽  
Dietary Risk ◽  
Dietary Risk Assessment

scholarly journals Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study

2020 ◽  
Author(s):  
Yuchen Luo ◽  
Yi Zhang ◽  
Ming Liu ◽  
Yihong Lai ◽  
Panpan Liu ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Real Time ◽  
High Performance ◽  
Detection System ◽  
Random Order ◽  
Colon Polyps ◽  
Clinical Environment ◽  
Polyp Detection ◽  
Link Type ◽  
Polyp Detection Rate

Abstract Background and aims Improving the rate of polyp detection is an important measure to prevent colorectal cancer (CRC). Real-time automatic polyp detection systems, through deep learning methods, can learn and perform specific endoscopic tasks previously performed by endoscopists. The purpose of this study was to explore whether a high-performance, real-time automatic polyp detection system could improve the polyp detection rate (PDR) in the actual clinical environment. Methods The selected patients underwent same-day, back-to-back colonoscopies in a random order, with either traditional colonoscopy or artificial intelligence (AI)-assisted colonoscopy performed first by different experienced endoscopists (> 3000 colonoscopies). The primary outcome was the PDR. It was registered with clinicaltrials.gov. (NCT047126265). Results In this study, we randomized 150 patients. The AI system significantly increased the PDR (34.0% vs 38.7%, p < 0.001). In addition, AI-assisted colonoscopy increased the detection of polyps smaller than 6 mm (69 vs 91, p < 0.001), but no difference was found with regard to larger lesions. Conclusions A real-time automatic polyp detection system can increase the PDR, primarily for diminutive polyps. However, a larger sample size is still needed in the follow-up study to further verify this conclusion. Trial Registration clinicaltrials.gov Identifier: NCT047126265

scholarly journals Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial

2021 ◽  
Vol 6 (1) ◽  
pp. e000648
Author(s):  
Swetha Bindu Velaga ◽  
Muneeswar Gupta Nittala ◽  
Michael S Ip ◽  
Luc Duchateau ◽  
SriniVas R Sadda
Keyword(s):  
Time Course ◽  
Vitreomacular Adhesion ◽  
Ellipsoid Zone ◽  
Post Hoc Analysis ◽  
Link Type ◽  
Phase Iiib ◽  
The Status ◽  
Registration Number ◽  
Post Hoc ◽  
And Control

Background/aimsOASIS is a Phase IIIb trial (NCT01429441) assessing long-term outcomes in subjects with symptomatic vitreomacular adhesion (VMA). The purpose of this study is to report on the frequency, severity, location and time course of ellipsoid zone (EZ) alterations in ocriplasmin-treated and sham control eyes in the OASIS study.Methods220 patients (146 ocriplasmin, 74 sham) subjects with VMA were enrolled in this masked post hoc analysis phase IIIb, randomised, sham-controlled double-masked multicentre clinical trial. A masked post hoc analysis of OCT images was performed at the Doheny Image Reading Center from subjects enrolled in the OASIS trial. The status of the EZ band was assessed in three different macular regions: the central subfield (CS) (≤1 mm diameter), the parafoveal area (PAA) (>1 to ≤3 mm) and the perifoveal area (PEA) (>3 to ≤6 mm). The EZ band was rated as normal/intact, full thickness macular hole (FTMH), abnormal but continuous, discontinuous/disrupted or absent at visits from baseline (pretreatment) to week 1 (day 7), month 1 (day 28), month 3, month 6, month 12 and the final follow-up at month 24. EZ band status was compared in both study and control eyes.ResultsA total of 208 patients (138 ocriplasmin, 70 sham) were included in this analysis. At baseline, FTMH was present in 48.6%, 8.0%, 0% and 52.8%, 2.9%, 0% in the CS, PAA and PEA of the ocriplasmin and sham groups, respectively. The EZ was graded to be abnormal but continuous, discontinuous/disrupted or absent at Baseline in 21.0%, 4.3%, 2.8% in the CS, PAA and PEA, respectively, of the ocriplasmin group; and 12.9%, 10.0%, 4.3% in the CS, PAA and PEA of the sham group. For the ocriplasmin group in the PAA, this frequency increased to 6.6% at week 1, was 9.8% at month 1, but improved to 3.8% at month 3, and remained stable to 1.6% at month 24. These differences, however, were not statistically significant.ConclusionsOcriplasmin treatment for symptomatic VMA was associated with EZ abnormalities in a small percentage of patients that was best assessed in regions (PEA) relatively unaffected by the VM interface disease at baseline. The EZ abnormalities were apparent by week 1, persisted at month 1, and appeared to resolve in the majority of cases by month 3.Trial registration numberNCT01429441

Hexabromocyclododecanes in breast milk from residents in Shenzhen, China: Implications for infant exposure

2018 ◽  
Vol 622-623 ◽  
pp. 1090-1097 ◽  
Author(s):  
Shaoyou Lu ◽  
Zhen Tan ◽  
Yousheng Jiang ◽  
Dongting Wu ◽  
Jianqing Zhang ◽  
...  
Keyword(s):  
Breast Milk ◽  
Infant Exposure

scholarly journals Immunoglobulin A antibodies directed againstCampylobacter jejuniflagellin present in breast–milk

1994 ◽  
Vol 112 (2) ◽  
pp. 359-365 ◽  
Author(s):  
I. Nachamkin ◽  
S. H. Fischer ◽  
X.-H. Yang ◽  
O. Benitez ◽  
A. Cravioto
Keyword(s):  
Breast Milk ◽  
Protective Effect ◽  
Statistical Significance ◽  
Immunoglobulin A ◽  
Specific Antibodies ◽  
Breastfed Infants ◽  
Milk Samples ◽  
The Difference ◽  
Campylobacter Infection ◽  
The Relationship

SUMMAYWe studied the relationship between IgA anti–campylobacter flagellin antibodies in breast milk samples and protection of breastfed infants living in a rural Mexican village from campylobacter infection. There were fewer episodes of campylobacter infection (symptomatic and asymptomatic combined) in infants breastfed with milk containing specific anti-flagellin antibodies (1.2/child/year, 95% CI 0.6–1.8) versus non–breastfed children (3.3/child/year, 95% CI 1.8–4.8; P < 0.01). Infants breastfed with milk that was antiflagellin antibody negative by ELISA also had fewer episodes of infection compared with non-breastfed children, but the difference did not reach statistical significance (1.8/child/year, 95% CI 0.7–3.0 versus 3.3/child/year, 95% CI 1.8–4.8, P > 0.05). Breastfeeding has a protective effect against campylobacter infection and is associated with the presence of specific antibodies directed against campylobacter flagellin.

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