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Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.

ABSTRACT: BACKGROUND:Treatment with nifurtimox (NF) for Chagas disease is discouraged during breast-feeding because no information on NF transfer into breast milk is available. NF is safe and effective for paediatric and adult Chagas disease. We evaluated the degree of NF transfer into breast milk in lactating women with Chagas disease. PATIENTS AND METHODS:Prospective study of a cohort of lactating women with Chagas disease. Patients were treated with NF for 1 month. NF was measured in plasma and milk by high performance liquid chromatography (HPLC). Breastfed infants were evaluated at admission, 7th and 30th day of treatment (and monthly thereafter, for 6 months). RESULTS:Lactating women with chronic Chagas disease (N = 10) were enrolled (median age 28 years, range 17-36). Median NF dose was 9.75 mg/kg/day three times a day (TID). Six mothers had mild adverse drug reactions (ADRs), but no ADRs were observed in any of the breastfed infants. No interruption of breastfeeding was observed. Median NF concentrations were 2.15 mg/L (Inter quartil range (IQR) 1.32-4.55) in milk and 0.30 mg/L (IQR 0.20-0.95) in plasma. Median NF milk/plasma ratio was 16 (range 8.75-30.25). Median relative infant NF dose (assuming a daily breastmilk intake of 150 mL/kg/day) was 6.7% of the maternal dose/kg/day (IQR 2.35-7.19%). CONCLUSIONS:The low concentrations of NF in breast milk and the normal clinical evaluation of the breastfed babies imply that maternal NF treatment for Chagas disease during breastfeeding is unlikely to lead to clinically relevant exposures in the breastfed infants. TRIAL REGISTRATION:Clinical trial registry name and registration number: ClinicalTrials.gov NCT01744405.

SUBMITTER: Moroni S

PROVIDER: S-EPMC6711540 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.

Moroni Samanta S Marson Maria Elena ME Moscatelli Guillermo G Mastrantonio Guido G Bisio Margarita M Gonzalez Nicolas N Ballering Griselda G Altcheh Jaime J García-Bournissen Facundo F

PLoS neglected tropical diseases 20190815 8

<h4>Background</h4>Treatment with nifurtimox (NF) for Chagas disease is discouraged during breast-feeding because no information on NF transfer into breast milk is available. NF is safe and effective for paediatric and adult Chagas disease. We evaluated the degree of NF transfer into breast milk in lactating women with Chagas disease.<h4>Patients and methods</h4>Prospective study of a cohort of lactating women with Chagas disease. Patients were treated with NF for 1 month. NF was measured in pla ...[more]

PMID: 31415566

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Project description:BackgroundWorldwide, many guidelines recommend the use of expressed breast milk (EBM) and maternal expression of breast milk for the prevention and treatment of neonatal hypoglycemia. However, the impact of both practices on neonatal hypoglycemia is unclear. This study aims to determine the effectiveness of EBM and maternal expression of breast milk in preventing and treating neonatal hypoglycemia.MethodsWe registered our review in PROSPERO (CRD42022328072). We systematically reviewed five databases and four clinical trial registries to identify randomized controlled trials (RCT), non-randomized studies of intervention (NRSI), and cohort studies that compared infants who received EBM to infants who did not, and similar study designs that compared infants whose mothers expressed breast milk to infants whose mothers did not. Two independent reviewers carried out screening, data extraction, and quality assessment. The quality of included RCT, NRSI, and cohort studies were respectively assessed with the Cochrane Risk of Bias 2, Risk Of Bias In Non-randomised Studies-of Interventions, and the Newcastle-Ottawa Scale tools. Results from studies on EBM were synthesized separately from those on maternal expression of breast milk. Meta-analysis was undertaken using Revman 5.4. and fixed-effect models.ResultsNone of the ten included studies was specifically designed to determine the effect of EBM or maternal expression of breast milk on neonatal hypoglycemia. The effect of EBM on neonatal hypoglycemia was not estimable. There was no difference in the risk of hypoglycaemia among neonates whose mothers expressed breast milk compared to those whose mothers did not [RR (95%CI); one RCT: 0.92 (0.77, 1.10), high-certainty evidence; one cohort: 1.10 (0.74, 1.39), poor quality study].ConclusionsThere is insufficient evidence to determine the effectiveness of EBM for preventing or treating neonatal hypoglycemia. Limited data suggests maternal breast milk expression may not alter the risk of neonatal hypoglycemia. High-quality randomized controlled trials are needed to determine the effectiveness of EBM and maternal expression of breast milk for the prevention and treatment of neonatal hypoglycemia.

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Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.

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Negligible exposure to nifurtimox through breast milk during maternal treatment for Chagas Disease.

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