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ScreenPlus: A comprehensive, multi-disorder newborn screening program

Kelly, Nicole R; Orsini, Joseph J; Goldenberg, Aaron J; Mulrooney, Niamh S; Boychuk, Natalie A; Clarke, Megan J; Paleologos, Katrina; Martin, Monica M; McNeight, Hannah; Caggana, Michele; Bailey, Sean M; Eiland, Lisa R; Ganesh, Jaya; Kupchik, Gabriel; Lumba, Rishi; Nafday, Suhas; Stroustrup, Annemarie; Gelb, Michael H; Wasserstein, Melissa P
The increasing availability of novel therapies highlights the importance of screening newborns for rare genetic disorders so that they may benefit from early therapy, when it is most likely to be effective. Pilot newborn screening (NBS) studies are a way to gather objective evidence about the feasibility and utility of screening, the accuracy of screening assays, and the incidence of disease. They are also an optimal way to evaluate the complex ethical, legal and social implications (ELSI) that accompany NBS expansion for disorders. ScreenPlus is a consented pilot NBS program that aims to enroll over 100,000 infants across New York City. The initial ScreenPlus panel includes 14 disorders and uses an analyte-based, multi-tiered screening platform in an effort to enhance screening accuracy. Infants who receive an abnormal result are referred to a ScreenPlus provider for confirmatory testing, management, and therapy as needed, along with longitudinal capture of outcome data. Participation in ScreenPlus requires parental consent, which is obtained in active and passive manners. Patient-facing documents are translated into the ten most common languages spoken at our nine pilot hospitals, all of which serve diverse communities. At the time of consent, parents are invited to receive a series of online surveys to capture their opinions about specific ELSI-related topics, such as NBS policy, residual dried blood spot retention, and the types of disorders that should be on NBS panels. ScreenPlus has developed a stakeholder-based, collective funding model that includes federal support in addition to funding from 14 advocacy and industry sponsors, all of which have a particular interest in NBS for at least one of the ScreenPlus disorders. Taken together, ScreenPlus is a model, multi-sponsored pilot NBS program that will provide critical data about NBS for a broad panel of disorders, while gathering key stakeholder opinions to help guide ethically sensitive decision-making about NBS expansion.
PMCID:10761901
PMID: 38173711
ISSN: 2214-4269
CID: 5737142

ScreenPlus: A comprehensive, multi-disorder newborn screening program

Kelly, Nicole R; Orsini, Joseph J; Goldenberg, Aaron J; Mulrooney, Niamh S; Boychuk, Natalie A; Clarke, Megan J; Paleologos, Katrina; Martin, Monica M; McNeight, Hannah; Caggana, Michele; Bailey, Sean M; Eiland, Lisa R; Ganesh, Jaya; Kupchik, Gabriel; Lumba, Rishi; Nafday, Suhas; Stroustrup, Annemarie; Gelb, Michael H; Wasserstein, Melissa P
The increasing availability of novel therapies highlights the importance of screening newborns for rare genetic disorders so that they may benefit from early therapy, when it is most likely to be effective. Pilot newborn screening (NBS) studies are a way to gather objective evidence about the feasibility and utility of screening, the accuracy of screening assays, and the incidence of disease. They are also an optimal way to evaluate the complex ethical, legal and social implications (ELSI) that accompany NBS expansion for disorders. ScreenPlus is a consented pilot NBS program that aims to enroll over 100,000 infants across New York City. The initial ScreenPlus panel includes 14 disorders and uses an analyte-based, multi-tiered screening platform in an effort to enhance screening accuracy. Infants who receive an abnormal result are referred to a ScreenPlus provider for confirmatory testing, management, and therapy as needed, along with longitudinal capture of outcome data. Participation in ScreenPlus requires parental consent, which is obtained in active and passive manners. Patient-facing documents are translated into the ten most common languages spoken at our nine pilot hospitals, all of which serve diverse communities. At the time of consent, parents are invited to receive a series of online surveys to capture their opinions about specific ELSI-related topics, such as NBS policy, residual dried blood spot retention, and the types of disorders that should be on NBS panels. ScreenPlus has developed a stakeholder-based, collective funding model that includes federal support in addition to funding from 14 advocacy and industry sponsors, all of which have a particular interest in NBS for at least one of the ScreenPlus disorders. Taken together, ScreenPlus is a model, multi-sponsored pilot NBS program that will provide critical data about NBS for a broad panel of disorders, while gathering key stakeholder opinions to help guide ethically sensitive decision-making about NBS expansion.
PMCID:10761901
PMID: 38173711
ISSN: 2214-4269
CID: 5737152

ScreenPlus: A comprehensive, multi-disorder newborn screening program

Kelly, Nicole R; Orsini, Joseph J; Goldenberg, Aaron J; Mulrooney, Niamh S; Boychuk, Natalie A; Clarke, Megan J; Paleologos, Katrina; Martin, Monica M; McNeight, Hannah; Caggana, Michele; Bailey, Sean M; Eiland, Lisa R; Ganesh, Jaya; Kupchik, Gabriel; Lumba, Rishi; Nafday, Suhas; Stroustrup, Annemarie; Gelb, Michael H; Wasserstein, Melissa P
The increasing availability of novel therapies highlights the importance of screening newborns for rare genetic disorders so that they may benefit from early therapy, when it is most likely to be effective. Pilot newborn screening (NBS) studies are a way to gather objective evidence about the feasibility and utility of screening, the accuracy of screening assays, and the incidence of disease. They are also an optimal way to evaluate the complex ethical, legal and social implications (ELSI) that accompany NBS expansion for disorders. ScreenPlus is a consented pilot NBS program that aims to enroll over 100,000 infants across New York City. The initial ScreenPlus panel includes 14 disorders and uses an analyte-based, multi-tiered screening platform in an effort to enhance screening accuracy. Infants who receive an abnormal result are referred to a ScreenPlus provider for confirmatory testing, management, and therapy as needed, along with longitudinal capture of outcome data. Participation in ScreenPlus requires parental consent, which is obtained in active and passive manners. Patient-facing documents are translated into the ten most common languages spoken at our nine pilot hospitals, all of which serve diverse communities. At the time of consent, parents are invited to receive a series of online surveys to capture their opinions about specific ELSI-related topics, such as NBS policy, residual dried blood spot retention, and the types of disorders that should be on NBS panels. ScreenPlus has developed a stakeholder-based, collective funding model that includes federal support in addition to funding from 14 advocacy and industry sponsors, all of which have a particular interest in NBS for at least one of the ScreenPlus disorders. Taken together, ScreenPlus is a model, multi-sponsored pilot NBS program that will provide critical data about NBS for a broad panel of disorders, while gathering key stakeholder opinions to help guide ethically sensitive decision-making about NBS expansion.
PMCID:10761901
PMID: 38173711
ISSN: 2214-4269
CID: 5737132

Effects of Inhaled Iloprost for the Management of Persistent Pulmonary Hypertension of the Newborn

Verma, Sourabh; Lumba, Rishi; Kazmi, Sadaf H; Vaz, Michelle J; Prakash, Shrawani Soorneela; Bailey, Sean M; Mally, Pradeep V; Randis, Tara M
OBJECTIVE: The study aimed to evaluate the effects of inhaled iloprost on oxygenation indices in neonates with persistent pulmonary hypertension of the newborn (PPHN). STUDY DESIGN/METHODS:) were recorded. RESULTS: < 0.05), with no significant change in required mean airway pressure over that same period. There was no change in vasopressor use or clinically significant worsening of platelets count, liver, and kidney functions after initiating iloprost. CONCLUSION/CONCLUSIONS: Inhaled iloprost is well tolerated and seems to have beneficial effects in improving oxygenation indices in neonates with PPHN who do not respond to iNO. There is a need of well-designed prospective trials to further ascertain the benefits of using inhaled iloprost as an adjunct treatment in neonates with PPHN who do not respond to iNO alone. KEY POINTS/CONCLUSIONS:· Inhaled iloprost seems to have beneficial effects in improving oxygenation indices in PPHN.. · Inhaled iloprost is generally well tolerated in newborns with PPHN.. · There is a need for prospective RCTs to further ascertain the benefits of using inhaled iloprost..
PMID: 33477175
ISSN: 1098-8785
CID: 4760862

Short-term outcomes of infants born to mothers with SARS-CoV-2 infection

Moffat, Michael A; Dessie, Almaz S; O'Leary, Kathryn; Lumba, Rishi; Rhee, David S
OBJECTIVE/UNASSIGNED:The rate of transmission of SARS-CoV-2 from mothers to infants in the peri- and post-natal period remains an area of ongoing investigation. This study aims to determine rates of development of clinically significant COVID-19 disease within 1 month among infants born to symptomatic and asymptomatic SARS-CoV-2 positive mothers. MATERIALS AND METHODS/UNASSIGNED:This was a single-center, retrospective cohort study of all infants born to SARS-CoV-2 positive mothers who were admitted to the Well Baby Nursery (WBN) at New York University Langone Hospital-Brooklyn from 23 March-23 September 2020. Infants born to asymptomatic mothers were allowed to room-in, while infants born to mothers with symptoms of SARS-CoV-2 were isolated and discharged home to an alternate primary caregiver. A phone follow-up program contacted mothers at 2 weeks and 1 month post discharge to inquire about newborn symptoms, maternal symptoms, personal protective equipment (PPE) usage, and any presentations to care. Medical records were also reviewed for clinic and hospital visits to determine if exposed infants developed any symptoms following discharge. RESULTS/UNASSIGNED:Of 1903 deliveries during the study period, 131 mothers (21 symptomatic, 110 asymptomatic) tested positive for SARS-CoV-2 and had infants admitted to the WBN. 57 infants (21 born to symptomatic mothers, 36 born to asymptomatic mothers) were tested prior to discharge, and none were positive. 121 of 133 infants had at least 1 follow up call in the study period. Of these, 31 had symptoms potentially concerning for SARS-CoV-2 infection or Multisystem Inflammatory Syndrome in Children, and 19 presented to medical care for these symptoms. 4 infants had SARS- CoV-2 testing after discharge, and none were positive. 2 infants were admitted to the hospital for fever but neither had a positive SARS-CoV-2 result. 65% of mothers reported always adhering to PPE recommendations. CONCLUSION/UNASSIGNED:Our results suggest that infants born both to symptomatic and asymptomatic mothers are unlikely to develop clinically significant COVID-19 disease in the peri- and post-natal periods.
PMCID:8425428
PMID: 34470140
ISSN: 1476-4954
CID: 5006502

Breast Milk and Breastfeeding of Infants Born to SARS-CoV-2 Positive Mothers: A Prospective Observational Cohort Study

Kunjumon, Bgee; Wachtel, Elena V; Lumba, Rishi; Quan, Michelle; Remon, Juan; Louie, Moi; Verma, Sourabh; Moffat, Michael A; Kouba, Insaf; Bennett, Terri-Ann; Mejia, Claudia Manzano De; Mally, Pradeep V; Lin, Xinhua; Hanna, Nazeeh
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/METHODS: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/CONCLUSIONS: 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/CONCLUSIONS:· 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..
PMID: 34182576
ISSN: 1098-8785
CID: 4965602

Characteristics of Hospitalized Children With SARS-CoV-2 in the New York City Metropolitan Area

Verma, Sourabh; Lumba, Rishi; Dapul, Heda M; Simson, Gabrielle Gold-von; Phoon, Colin K; Phil, M; Lighter, Jennifer L; Farkas, Jonathan S; Vinci, Alexandra; Noor, Asif; Raabe, Vanessa N; Rhee, David; Rigaud, Mona; Mally, Pradeep V; Randis, Tara M; Dreyer, Benard; Ratner, Adam J; Manno, Catherine S; Chopra, Arun
PMID: 33033078
ISSN: 2154-1671
CID: 4627202

Outcomes of Maternal-Newborn Dyads After Maternal SARS-CoV-2

Verma, Sourabh; Bradshaw, Chanda; Auyeung, N S Freda; Lumba, Rishi; Farkas, Jonathan S; Sweeney, Nicole B; Wachtel, Elena V; Bailey, Sean M; Noor, Asif; Kunjumon, Bgee; Cicalese, Erin; Hate, Rahul; Lighter, Jennifer L; Alessi, Samantha; Schweizer, William E; Hanna, Nazeeh; Roman, Ashley S; Dreyer, Benard; Mally, Pradeep V
PMID: 32737153
ISSN: 1098-4275
CID: 4553402

Neonatal Intensive Care Unit Preparedness for the Novel Coronavirus Disease-2019 Pandemic: A New York City Hospital Perspective

Verma, Sourabh; Lumba, Rishi; Lighter, Jennifer L; Bailey, Sean M; Wachtel, Elena V; Kunjumon, Bgee; Alessi, Samantha; Mally, Pradeep V
In January 2020, China reported a cluster of cases of pneumonia associated with a novel pathogenic coronavirus provisionally named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2). Since then, Coronavirus Disease 2019 (COVID-19) has been reported in more than 180 countries with approximately 3 million known infections and more than 210,000 deaths attributed to this disease. The majority of confirmed COVID-19 cases have been reported in adults, especially older individuals with co-morbidities. Children have had a relatively lower rate and a less serious course of infection as reported in the literature to date. One of the most vulnerable pediatric patient populations is cared for in the neonatal intensive care unit. There is limited data on the effect of COVID-19 in fetal life, and among neonates after birth. Therefore there is an urgent need for proactive preparation, and planning to combat COVID-19, as well as to safeguard patients, their families, and healthcare personnel. This review article is based on the Centers for Disease Control and Prevention's (CDC) current recommendations for COVID-19 and its adaptation to our local resources. The aim of this article is to provide basic consolidated guidance and checklists to clinicians in the neonatal intensive care units in key aspects of preparation needed to counter exposure or infection with COVID-19. We anticipate that CDC will continue to update their guidelines regarding COVID-19 as the situation evolves, and we recommend monitoring CDC's updates for the most current information.
PMCID:7221379
PMID: 32410913
ISSN: 1538-3199
CID: 4431642

Neonate Born to a Mother with a Diagnosis of Suspected Intra-Amniotic Infection versus COVID-19 or Both [Case Report]

Lumba, Rishi; Remon, Juan; Louie, Moi; Quan, Michelle; Verma, Sourabh; Rigaud, Mona; Kunjumon, Bgee
A diagnosis of intra-amniotic infection is typically made based on clinical criteria, including maternal intrapartum fever and one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia. The diagnosis can also be made in patients with an isolated fever of 39°C, or greater, without any other clinical risk factors present. Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, has been noted to have varying signs and symptoms over the course of the disease including fever, cough, fatigue, anorexia, shortness of breath, sputum production, and myalgia. In this report, we detail a case of a newborn born to a mother with a clinical diagnosis of intra-amniotic infection with maternal fever and fetal tachycardia, who was then found to be SARS-CoV-2 positive on testing. Due to the varying presentation of COVID-19, this case illustrates the low threshold needed to test mothers for SARS-CoV-2 in order to prevent horizontal transmission to neonates and to healthcare providers.
PMCID:7383342
PMID: 32733734
ISSN: 2090-6803
CID: 4540702