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Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso.
Mennecier, A, Kankasa, C, Fao, P, Moles, JP, Eymard-Duvernay, S, Mwiya, M, Kania, D, Chunda-Liyoka, C, Sakana, L, Rutagwera, D, et al
Contemporary clinical trials. 2021;:106402
Abstract
Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6-8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number (www.clinicaltrials.gov): NCT03869944. Submission category: Study Design, Statistical Design, Study Protocols.
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[Epidemiology, management and risk of SARS-CoV-2 transmission in a cohort of newborns born to mothers diagnosed with COVID-19 infection].
Solís-García, G, Gutiérrez-Vélez, A, Pescador Chamorro, I, Zamora-Flores, E, Vigil-Vázquez, S, Rodríguez-Corrales, E, Sánchez-Luna, M
Anales de pediatria. 2021;(3):173-178
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INTRODUCTION The impact of maternal SARS-CoV-2 infection and its risk of vertical transmission is still not well known. Recommendations from scientific societies seek to provide safety for newborns without compromising the benefits of early contact. The aim of the study is to describe characteristics and evolution of newborns born to mothers with SARS-CoV-2 infection, as well as the implemented measures following recommendations from the Sociedad Española de Neonatología. METHODS Observational, prospective and single-center cohort study. A specific circuit was designed for mothers with SARS-CoV-2 infection and their newborns. Epidemiological and clinical data were collected. PCR were performed in newborns at delivery and at 14 days of age. RESULTS 73 mothers and 75 newborns were included in the study. 95.9% of maternal infections were diagnosed during the third trimester of pregnancy, 43.8% were asymptomatic. Median gestational age was 38 weeks (IQR: 37-40), 25.9% of newborns required admission to Neonatology. Skin-to-skin mother care was performed in 68% of newborns, 80% received exclusive maternal or donated breast milk during hospital stay. No positive PCR results were observed in newborns at delivery, one case of positive PCR was observed in an asymptomatic neonate at 14 days of age. CONCLUSIONS Risk of SARS-CoV-2 transmission is low when complying to the recommendations issued by Sociedad Española de Neonatología, allowing rooming-in and promoting breastfeeding.
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Inositol and vitamin D may naturally protect human reproduction and women undergoing assisted reproduction from Covid-19 risk.
Bezerra Espinola, MS, Bertelli, M, Bizzarri, M, Unfer, V, Laganà, AS, Visconti, B, Aragona, C
Journal of reproductive immunology. 2021;:103271
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In late 2019, the new Coronavirus has been identified in the city of Wuhan then COVID-19 spreads like wildfire in the rest of the world. Pregnant women represent a risk category for increased abortion rates and vertical transmission with adverse events on the newborns has been recently confirmed. The scientific world is struggling for finding an effective cure for counteracting symptomatology. Today, there are many therapeutic proposes but none of them can effectively counteract the infection. Moreover, many of these compounds show important side effects not justifying their use. Scientific literature reports an immune system over-reaction through interleukins-6 activation. In this regard, the possibility to control the immune system represents a possible strategy for counteracting the onset of COVID-19 symptomatology. Vitamin D deficiency shows increased susceptibility to acute viral respiratory infections. Moreover, Vitamin D seems involved in host protection from different virus species by modulating activation and release of cytokines. Myo-inositol down-regulates the expression of IL-6 by phosphatidyl-inositol-3-kinase (PI3K) pathway. Furthermore, myo-inositol is the precursor of phospholipids in the surfactant and it is applied for inducing surfactant synthesis in infants for treating respiratory distress syndrome (RDS). This review aims to summarize the evidence about COVID-19 infection in pregnant women and to encourage the scientific community to investigate the use of Vitamin D and Myo-inositol which could represent a possible preventive treatment for pregnant women or women undergoing assisted reproductive technologies (ART).
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Breast Milk and Breastfeeding of Infants Born to SARS-CoV-2 Positive Mothers: A Prospective Observational Cohort Study.
Kunjumon, B, Wachtel, EV, Lumba, R, Quan, M, Remon, J, Louie, M, Verma, S, Moffat, MA, Kouba, I, Bennett, TA, et al
American journal of perinatology. 2021;(11):1209-1216
Abstract
OBJECTIVE There are limited published data on the transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus from mothers to newborns through breastfeeding or from breast milk. The World Health Organization released guidelines encouraging mothers with suspected or confirmed COVID-19 to breastfeed as the benefits of breastfeeding outweighs the possible risk of transmission. The objective of this study was to determine if SARS-CoV-2 was present in the breast milk of lactating mothers who had a positive SARS-CoV-2 nasopharyngeal swab test prior to delivery, and the clinical outcomes for their newborns. STUDY DESIGN This was a single-center, observational, prospective cohort study. Maternal-newborn dyads that delivered at New York University Langone Hospital Brooklyn with confirmed maternal SARS-CoV-2 positive screen test at the time of admission were recruited for the study. Breast milk samples were collected during postpartum hospitalization and tested for the presence of SARS-CoV-2 genes N1 and N2 by two-step reverse transcription polymerase chain reaction. Additionally, the clinical characteristics of the maternal newborn dyad, results of nasopharyngeal SARS-CoV-2 testing, and neonatal follow-up data were collected. RESULTS A total of 19 mothers were included in the study and their infants who were all fed breast milk. Breast milk samples from 18 mothers tested negative for SARS-CoV-2, and 1 was positive for SARS-CoV-2 RNA. The infant who ingested the breast milk that tested positive had a negative nasopharyngeal test for SARS-CoV-2, and had a benign clinical course. There was no evidence of significant clinical infection during the hospital stay or from outpatient neonatal follow-up data for all the infants included in this study. CONCLUSION In a small cohort of SARS-CoV-2 positive lactating mothers giving birth at our institution, most of their breast milk samples (95%) contained no detectable virus, and there was no evidence of COVID-19 infection in their breast milk-fed neonates. KEY POINTS · Breast milk may rarely contain detectable SARS-CoV-2 RNA and was not detected in asymptomatic mothers.. · Breast milk with detectable SARS-CoV-2 RNA from a symptomatic mother had no clinical significance for her infant.. · Breast feeding with appropriate infection control instructions appears to be safe in mother with COVID infection..
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COVID-19: Relationship and Impact on Breastfeeding-A Systematic Review.
Pérez-Bermejo, M, Peris-Ochando, B, Murillo-Llorente, MT
Nutrients. 2021;(9)
Abstract
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that was declared a Public Health Emergency of International Concern by the World Health Organization (WHO). One major problem faced is whether breastfeeding by mothers infected with the virus is safe. The objective of this work is to study the impact that the SARS-CoV-2 virus can have on breastfeeding, and whether the virus or antibodies can be transmitted from mother to child through milk. We carried out a systematic review of studies focusing on the impact of SARS-CoV-2 on breastfeeding by mothers infected with the virus. The bibliographic search was done through Medline (Pubmed), MedlinePlus and Google Scholar. From 292 records, the title and summary of each were examined according to the criteria, and whether they meet the selection criteria was also analysed. A total of 30 articles are included, of which 26 deal with the study of RNA virus in breastmilk and its involvement in breastfeeding and four on the study of SARS-CoV-2 antibodies in milk. Most studies have been conducted in China. Breastfeeding by mothers infected with SARS-CoV-2 is highly recommended for infants, if the health of the mother and the infant allow for it. Direct breastfeeding and maintaining appropriate protective measures should be encouraged. Should the mother's health condition not permit direct breastfeeding, infants should be fed with pumped breastmilk or donor milk.
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Best Practices for Human Milk Collection for COVID-19 Research.
McGuire, MK, Seppo, A, Goga, A, Buonsenso, D, Collado, MC, Donovan, SM, Müller, JA, Ofman, G, Monroy-Valle, M, O'Connor, DL, et al
Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2021;(1):29-38
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In addition to providing life-giving nutrients and other substances to the breastfed infant, human milk can also represent a vehicle of pathogen transfer. As such, when an infectious disease outbreak, epidemic, or pandemic occurs-particularly when it is associated with a novel pathogen-the question will naturally arise as to whether the pathogen can be transmitted through breastfeeding. Until high-quality data are generated to answer this question, abandonment of breastfeeding due to uncertainty can result. The COVID-19 pandemic, which was in full swing at the time this document was written, is an excellent example of this scenario. During these times of uncertainty, it is critical for investigators conducting research to assess the possible transmission of pathogens through milk, whether by transfer through the mammary gland or contamination from respiratory droplets, skin, breast pumps, and milk containers, and/or close contact between mother and infant. To promote the most rigorous science, it is critical to outline optimal methods for milk collection, handling, storage, and analysis in these situations, and investigators should openly share their methods in published materials. Otherwise, the risks of inconsistent test results from preanalytical and analytical variation, false positives, and false negatives are unacceptably high and the ability to provide public health guidance poor. In this study, we provide "best practices" for collecting human milk samples for COVID-19 research with the intention that this will also be a useful guide for future pandemics.
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Guidance on breastfeeding during the Covid-19 pandemic.
Calil, VMLT, Krebs, VLJ, Carvalho, WB
Revista da Associacao Medica Brasileira (1992). 2020;(4):541-546
Abstract
OBJECTIVE These recommendations aim to provide guidance on breastfeeding for mothers with suspected or confirmed Covid-19. METHODS We performed a review of the recent medical literature on breastfeeding mothers with suspected or confirmed Covid-19, focusing on the neonatal period. RESULTS We analyzed 20 recent publications on breastfeeding, Covid-19, and its transmission through breastmilk. We presented possible options for breastfeeding and their consequences for the mother and the child. CONCLUSION All maternal decisions in relation to breastfeeding are justifiable since the infection by Covid-19 is still poorly known. However, puerperal women and their families must be very well informed to make a conscious choice based on the information available in the literature so far.
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Breastfeeding during the COVID-19 pandemic: Suggestions on behalf of woman study group of AMD.
Giuliani, C, Li Volsi, P, Brun, E, Chiambretti, A, Giandalia, A, Tonutti, L, Di Bartolo, P, Napoli, A
Diabetes research and clinical practice. 2020;:108239
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SARS-Cov2 infection has recently spread to Italy with important consequences on pregnancy management, mother and child health and mother-child contact. Breastfeeding improves the health of mother and child and reduces risk of neonatal infection with other pathogens that are likely to cause serious illness. To date no evidence confirmed COVID-19 vertical transmission from infected pregnant mother to their fetus. However it is well known that an infected mother can transmit the COVID-19 virus through respiratory droplets during breastfeeding or intimate contact. Thus, the mothers with known or suspected COVID-19 should adhere to standard and contact precautions during breastfeeding. Woman Study Group of AMD, after reviewing current knowledge about COVID-19 vertical transmission and the compatibility of breastfeeding in COVID-19 mother, the available recommendations from Health Care Organizations and main experts opinions, issued the following suggestions on breastfeeding during the COVID-19 pandemic, addressed both to mothers with and without diabetes. It should be considered that following suggestions may change in the future when more evidence is acquired regarding SARS-Cov2 infection.
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Pregnancy and Breastfeeding During COVID-19 Pandemic: A Systematic Review of Published Pregnancy Cases.
Rodrigues, C, Baía, I, Domingues, R, Barros, H
Frontiers in public health. 2020;:558144
Abstract
Background: The COVID-19 pandemic is an emerging concern regarding the potential adverse effects during pregnancy. This study reviews knowledge on the impact of COVID-19 on pregnancy and describes the outcome of published cases of pregnant women diagnosed with COVID-19. Methods: Searches were conducted in PubMed®, Scopus®, Web of Science®, and MedRxiv® up to 26th June 2020, using PRISMA standards, to identify original published studies describing pregnant women at any gestational age diagnosed COVID-19. There were no date or language restrictions on the search. All identified studies were included irrespective of assumptions on study quality. Results: We identified 161 original studies reporting 3,985 cases of pregnant women with COVID-19 (1,007 discharged while pregnant). The 2,059 published cases with pregnancy outcomes resulted in 42 abortions, 21 stillbirths, and 2,015 live births. Preterm birth occurred in 23% of cases. Around 6% of pregnant women required admission to an intensive care unit and 28 died. There were 10 neonatal deaths. From the 163 cases with amniotic fluid, placenta, and/or cord blood analyzed for the SARS-CoV-2 virus, 10 were positive. Sixty-one newborns were positive for SARS-CoV-2. Four breast milk samples from 92 cases showed evidence of SARS-CoV-2. Conclusion: Emerging evidence suggests that vertical transmission is possible, however, there is still a limited number of reported cases with intrapartum samples. Information, counseling and adequate monitoring are essential to prevent and manage adverse effects of SARS-CoV-2 infection during pregnancy.
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Breastfeeding and coronavirus disease-2019: Ad interim indications of the Italian Society of Neonatology endorsed by the Union of European Neonatal & Perinatal Societies.
Davanzo, R, Moro, G, Sandri, F, Agosti, M, Moretti, C, Mosca, F
Maternal & child nutrition. 2020;(3):e13010
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The recent COVID-19 pandemic has spread to Italy with heavy consequences on public health and economics. Besides the possible consequences of COVID-19 infection on a pregnant woman and the fetus, a major concern is related to the potential effect on neonatal outcome, the appropriate management of the mother-newborn dyad, and finally the compatibility of maternal COVID-19 infection with breastfeeding. The Italian Society on Neonatology (SIN) after reviewing the limited scientific knowledge on the compatibility of breastfeeding in the COVID-19 mother and the available statements from Health Care Organizations has issued the following indications that have been endorsed by the Union of European Neonatal & Perinatal Societies (UENPS). If a mother previously identified as COVID-19 positive or under investigation for COVID-19 is asymptomatic or paucisymptomatic at delivery, rooming-in is feasible, and direct breastfeeding is advisable, under strict measures of infection control. On the contrary, when a mother with COVID-19 is too sick to care for the newborn, the neonate will be managed separately and fed fresh expressed breast milk, with no need to pasteurize it, as human milk is not believed to be a vehicle of COVID-19. We recognize that this guidance might be subject to change in the future when further knowledge will be acquired about the COVID-19 pandemic, the perinatal transmission of SARS-CoV-2, and clinical characteristics of cases of neonatal COVID-19.
