News Release
Tuesday, June 21, 2016
Worldwide initiative to enroll roughly 10,000 women.
“This large prospective study promises to offer essential Brand-new data that will certainly suggestions guide the medical and public healthiness responses to the Zika virus epidemic.”
—Anthony S. Fauci, M.D., Director, NIAID
The National Institutes of healthiness and Fundacao Oswaldo Cruz-Fiocruz (Fiocruz), a national scientific research organization linked to the Brazilian Ministry of Health, have actually begun a multi-country study to evaluate the magnitude of healthiness risks that Zika virus infection poses to pregnant women and their creating fetuses and infants. The study is opening in Puerto Rico and will certainly expand to several areas in Brazil, Colombia and various other locations that are experiencing energetic neighborhood transmission of the virus.
Zika virus is spread primarily through bites from infected Aedes aegypti mosquitoes, even though various other forms of transmission — notably, mother-to-kid and sexual transmission — likewise occur. energetic virus transmission currently is ongoing in 60 countries and territories. The virus has actually been linked to a spike in cases of microcephaly, a condition in which babies are born along with abnormally small heads and feasible neurological damage, sparking Worldwide concern. Along with microcephaly, various other complications have actually been detected in pregnancies and among fetuses and infants infected along with Zika virus prior to birth, including miscarriage, stillbirth, absent or poorly produced brain structures, eye defects, hearing deficits, and impaired growth.
The Zika in Infants and Pregnancy (ZIP) study aims to enroll as several as 10,000 pregnant women ages 15 years and older at up to 15 sites. The participants will certainly be in their very first trimester of pregnancy and will certainly be followed throughout their pregnancies to figure out if they become infected along with Zika virus and if so, just what outcomes result for the two mother and child. The participants’ infants will certainly be carefully followed for at least one year after birth.
The National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of kid healthiness and Human Improvement (NICHD), and the National Institute of Environmental healthiness Sciences (NIEHS), all of portion of the NIH, are funding and conducting the study, along along with Fiocruz.
“The full scope of the effect of Zika virus in pregnancy has actually not yet been fully determined,” said NIAID Director Anthony S. Fauci, M.D. “This large prospective study promises to offer essential Brand-new data that will certainly suggestions guide the medical and public healthiness responses to the Zika virus epidemic.”
“Zika virus has actually spread promptly through the Americas,” said NICHD Acting Director Catherine Y. Spong, M.D. “We look forward to that this study will certainly offer essential write-up on the link between Zika infection and pregnancy complications and inform strategies to suggestions safeguard the healthiness of mothers and their newborns.”
“A mother’s environment could be an essential portion of the Zika virus puzzle,” said NIEHS Director Linda Birnbaum, Ph.D. “We’ve included environmental measures in the study and will certainly likewise be evaluating nourishment and socio-economic status.”
The researchers strategy to compare birth outcomes between mothers that were infected along with Zika virus and those that were not, documenting the frequency of miscarriage, preterm birth, microcephaly, malformations of the nervous system, and various other complications. The researchers likewise seek to compare the risk of pregnancy complications among women that have actually symptoms of Zika virus infection and those that are infected yet do not have actually symptoms. Additionally, the study will certainly evaluate exactly how the timing of infection affects pregnancy outcomes and the role environmental influences, social determinants and various other infections, such as dengue virus infection, might play on the healthiness of the study participants and their newborns.
Women participating in the ZIP study will certainly be monitored monthly for the duration of their pregnancies then 6 weeks after delivery. They will certainly have actually a bodily examination and be asked to offer blood, urine, saliva and vaginal swab samples at study entry and at each monthly prenatal care visit. If the participants note that they will certainly be receiving an amniocentesis in connection along with their clinical care, the research group will certainly arrange along with the participant and her obstetrician to obtain a sample of the amniotic fluid to test for Zika infection. The participants will certainly be instructed regarding the signs and symptoms of acute Zika virus infection and will certainly be asked to notify their clinic as soon as possible if they experience symptoms. Post-delivery, a breast dairy sample, if available, will certainly be obtained for Zika testing. Infants whose mothers consent to their participation in the study will certainly be evaluated within 48 hours of birth and again at three, 6 and 12 months.
“This study, in partnership along with NIH, is important to elucidating the scientific complexity of the Zika virus,” said Fiocruz President Paulo Gadelha. “It will certainly be fundamental to creating prevention and treatment strategies versus the disease.”
It is essential to note that the ZIP study is a research initiative that is distinct from and complementary to public healthiness registries underway in the United States (U.S. Zika Public healthiness Registry), Puerto Rico (Zika energetic Pregnancy Surveillance System), and Colombia (SIVIGILA/Projecto Vez). These registries are population-based and collect observations from medical evaluations and testing along with the intent of providing write-up for public healthiness action.
For much more write-up regarding the ZIP study, see the Questions and Answers: The Zika in Infants and Pregnancy (ZIP) Study.
NIAID conducts and supports research — at NIH, throughout the United States, and international — to study the induces of infectious and immune-mediated diseases, and to create much better means of preventing, diagnosing and treating these illnesses. News releases, reality sheets and various other NIAID-related components are available on the NIAID website.
NICHD conducts and supports research in the United States and throughout the globe on fetal, infant and kid development; maternal, kid and family health; reproductive biology and population issues; and medical rehabilitation. For much more information, visit NICHD’s website.
NIEHS supports research to already know the effects of the environment on human healthiness and is portion of NIH. For much more write-up on environmental healthiness topics, visit www.niehs.nih.gov. Subscribe to one or much more of the NIEHS news lists to continue to be current on NIEHS news, press releases, grant opportunities, training, events and publications.
About the National Institutes of healthiness (NIH):
NIH, the nation’s medical research agency, involves 27 Institutes and Centers and is a component of the U.S. Department of healthiness and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for the two common and rare diseases. For much more write-up regarding NIH and its programs, visit www.nih.gov.
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