[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-morbidity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-morbidity":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100589696","biological-impacts-of-rising-temperatures-on-maternal-fetal-and-newborn-health-a-cohort-study-birth-cohort-100589696",false,"NCT06957769","Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)","BIRTH","Inclusion Criteria:\n\n* Single or multiple live pregnancy confirmed through ultrasound\n* Gestational age less than or equal to 13 weeks and 6 days at enrollment\n* At least 18 years of age\n* Permanent resident of the study district and plans to deliver within the district\n* Willing and able to attend study clinic visits and comply with study procedures throughout pregnancy\n\nExclusion Criteria:\n\n• Plan to relocate outside the district for more than 3 months during the study period",true,"FEMALE","18 Years",{"count":20,"type":21},6000,"ESTIMATED","OBSERVATIONAL","The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study also aims to understand how the body responds to heat stress during pregnancy and how this might lead to pregnancy complications and birth problems like early birth or low birth weight.\n\nThe main questions that the study aims to answer are:\n\n1. What are the acute and chronic effects of environmental heat exposure on pregnancy and birth outcomes across different trimesters?\n2. Through which biological pathways does heat stress impact maternal, fetal, and infant health across varying gestational ages?\n3. How do socio-demographic factors, maternal characteristics, and nutritional status of women modify the relationship between environmental heat exposure and adverse pregnancy outcomes?\n\nThe study will take place in rural parts of Sindh, Pakistan. These areas often experience extreme heat and have limited access to electricity or cooling systems like fans or air conditioners.\n\nThis study will include pregnant women who are in their first trimester (under 14 weeks of pregnancy). Before starting any study activities, researchers will explain the study to each woman in a language she understands and ask for her written permission to take part (informed consent).\n\nAt the beginning of the study, participants will visit a study clinic. During this visit, researchers will check their height and weight, perform an ultrasound, and collect a small amount of blood for testing. Participants will also be asked to wear a small device that measures the air temperature and humidity in their surroundings.\n\nThe researchers will follow each participant during her pregnancy, with visits during the second and third trimesters at the study clinic. At each visit, researchers will check how much heat the participant has been exposed to using the data from the device and from her own answers to a simple questionnaire. The questionnaire will have questions about their heat exposure at work, home, type of clothing, and how they deal with hot weather. Serial ultrasound, blood and urine tests will be conducted so researchers can study signs of stress, hydration, and other changes in the body. A smaller group of participants will also wear a device to measure their body skin temperature, heart rate, physical activity and sleep during pregnancy.\n\nWhen the baby is born, researchers will collect information about the birth, including the baby's weight and length, the time of delivery, and whether there were any complications during birth. After delivery, both the mother and baby will be followed for up to 12 months. During this time, the research team will check the health of both the mother and baby and see how heat exposure during pregnancy may affect the baby's growth over time. At delivery, placental weight and volume will be collected for a smaller group of women. Breastmilk sampling will also be done for this group of women to understand the effect of high temperatures on breastmilk quality.\n\nThis study does not involve any treatment or medicine. Instead, researchers will observe the participants to learn how real-life heat exposure affects them during pregnancy. The findings from this study may help public health officials and governments find better ways to protect pregnant women and babies from the harmful effects of climate change and extreme heat, especially in places with limited resources.",[25,26,27,28,29,30,31,32,33],"Low Birth Weight Baby","Small for Gestational Age (SGA)","Preterm Birth","Pregnancy Complications","Birth Outcome, Adverse","Heat Strain","Infant Morbidity","Infant Mortality","Neonatal Mortality",[35,36,37,38,39,40,41],"heat stress","high ambient temperature","climate change","birth outcomes","pregnancy","cohort study","Pakistan","RECRUITING","2025-11-26",{"date":45,"type":46},"2025-12-03","ACTUAL",{"date":48,"type":46},"2025-05-07",{"date":50,"type":21},"2028-06-30",{"name":52,"class":53},"Aga Khan University","OTHER",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100528995","influenza--covid-19-obstetric-and-perinatal-epidemiology-study-in-india-100528995","NCT06168019","Influenza & COVID-19 Obstetric and Perinatal Epidemiology Study in India","Influenza & COVID-19 Obstetric and Perinatal Epidemiology (ICOPE) Study in India","ICOPE","Inclusion Criteria:\n\nWomen aged 18 to 50 years registering for antenatal care (ANC) at Government Medical College Hospital (GMC) Nagpur, India\n\n* Estimated Gestational Age at registration \\\u003C14 weeks based on ultrasound report at the baseline study visit;\n* Intends to receive pregnancy, labor and delivery and neonatal care at GMC;\n* Plans to live within the city limits of Nagpur throughout their pregnancy and labor and delivery to facilitate access to GMC for evaluation of ILI and COVID-19 symptoms;\n* Willing to be contacted two times per week by call or text for ILI\u002F COVID-19 symptom screening and return to GMC for evaluation and an NP swab\u002Fevaluation if symptoms are reported;\n* Willing to take temperature with the provided digital thermometer, and maintain a symptom diary after training;\n* Willing to provide information on pregnancy and neonatal outcomes if care occurs outside GMC;\n* Willing to permit venous blood draws on at least 4 timepoints --1) Baseline study visit, 2)28-34 weeks, 3) 37 weeks - prior to delivery and 4) after delivery;\n* Willing to permit blood draws if hospitalized at GMC for COVID-19 infection;\n* Willing to consent to participate in the study\n\nExclusion Criteria:\n\n* Anyone who is deemed to have limited decision-making capacity as defined by Boston University IRB i.e. Substantial impairment of cognitive functions (e.g. attention, comprehension, memory, and intellect), or conditions that might affect their cognitive functions.\n* Anyone who is deemed to have limited capacity to consent as defined by Boston University Institutional Review Board (IRB) i.e. The ability to provide legally effective consent to enroll in a research study (AAHRPP definition).","50 Years",{"count":64,"type":21},10000,"This study will be conducted as a prospective cohort study, enrolling all eligible women in their first trimester of pregnancy during a baseline visit during week 6-13 of pregnancy at Government Medical College Hospital, Nagpur. The Hospital provides primary, secondary, and tertiary care and the obstetric department delivers about 10,000 babies a year. The hypothesis is that co-infection of other respiratory viruses (ORV), particularly COVID-19 and Influenza increases the risk of adverse pregnancy outcomes in mothers and babies and could address the current standard of care in India to not vaccinate pregnant women during pregnancy, by either encouraging vaccination against both viruses before planning a pregnancy or during pregnancy based on global data supporting the safety of this strategy.",[67,68,69,70,71,31],"Influenza","COVID-19","SARS-COV-2 Infection","Other Respiratory Viruses","Perinatal Morbidity",[73,74,75,76,77],"Pregnant women","Government Medical College Hospital, Nagpur, India","Covid-19 vaccination","Antenatal care","Postpartum",{"date":79,"type":46},"2025-11-28",{"date":81,"type":46},"2023-12-26",{"date":83,"type":21},"2028-06",{"name":85,"class":53},"Boston University",2,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":86},"100536644","increasing-neonatal-hiv-test-and-treat-to-maximize-the-long-term-impact-on-infant-health-and-novel-infant-antiretroviral-treatment-100536644","NCT06267508","Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment","LIFE2Scale","Inclusion Criteria:\n\n1. Voluntary and informed consent of the mother for her own study participation (if applicable);\n2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study;\n3. Mothers\u002Flegal guardians ≥18 years of age;\n4. Documented maternal HIV infection;\n5. Willingness to consent to HIV testing for the child and herself (or just her child); and\n6. Willingness to consent to active tracing including home tracing.\n\n   Exclusion Criteria:\n7. Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her.\n8. Having delivered more than 72h (3 days) ago;\n9. Prisoners;\n10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;\n11. Stillbirths;\n12. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;\n13. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or\n14. Unlikely to comply with protocol as judged by the principal investigator or his designate",{"count":20,"type":21},"This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.",[97,98,99,31,100],"Vertical Human Immunodeficiency Virus Transmission","HIV Infection Pediatric","Infant Death","Infant, Newborn, Diseases",[102,103,104,105],"Prevention of Vertical HIV Transmission (PVHT)","Infant HIV Prophylaxis","Early Infant HIV Diagnosis","Infant Antiretroviral Treatment","2024-11-14",{"date":108,"type":46},"2024-11-18",{"date":110,"type":46},"2024-04-30",{"date":112,"type":21},"2025-12",{"name":114,"class":53},"Michael Hoelscher"]