[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neonatal-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neonatal-hypoglycemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,85,107,131,156,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628527","continuous-glucose-monitoring-in-newborns-of-mothers-with-insulin-treated-gestational-diabetes-mellitus-100628527",false,"NCT07462793","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus","COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial","COMET-GDM","Inclusion Criteria:\n\n* Maternal age of 18 years or older\n* Singleton pregnancy\n* Insulin-treated gestational diabetes mellitus\n\nExclusion Criteria:\n\n* Multifetal pregnancy\n* Congenital malformations or metabolic defects in the newborn\n* Preterm birth (defined as birth \\\u003C37 weeks of gestation)\n* Smoking during pregnancy\n* Preeclampsia, fetal growth restriction\n* Perinatal asphyxia\n* Congenital infections in the newborn\n* Adverse skin reactions (eczema, wounds) in the planned sensor insertion area",true,"ALL","1 Minute","30 Minutes",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26],"NA","The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.",[29,30],"Neonatal Hypoglycemia","Gestational Diabetes Mellitus (GDM)",[32,33,34,35],"gestational diabetes mellitus","neonatal hypoglycemia","insulin-treated gestational diabetes","neurodevelopmental outcomes","NOT_YET_RECRUITING","2026-03-08",{"date":39,"type":40},"2026-03-10","ACTUAL",{"date":42,"type":23},"2026-03",{"date":44,"type":23},"2027-12",{"name":46,"class":47},"Institute of Mother and Child, Warsaw, Poland","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413","NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","0 Hours","48 Hours",{"count":60,"type":23},1444,[62],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[29,65,66,67,68,69,70],"Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Neonatal Intensive Care Unit","Breastfeeding","Mental Health Issue",[72,73],"Pasteurised donor human milk","Donor breastmilk","RECRUITING","2026-01-29",{"date":77,"type":40},"2026-02-02",{"date":79,"type":40},"2025-12-04",{"date":81,"type":23},"2028-12",{"name":83,"class":47},"The University of Queensland",4,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":24,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100609661","the-feasibility-of-cream-for-treatment-of-neonatal-hypoglycemia-100609661","NCT07217483","The Feasibility of Cream for Treatment of Neonatal Hypoglycemia","The Feasibility of Prolacta CR for Treatment of Neonatal Hypoglycemia","Inclusion Criteria:\n\n* Newborns at risk for hypoglycemia (born to mothers with diabetes, small for gestational age, large for gestational age, late preterm born 35 to 37 weeks gestational age)\n\nExclusion Criteria:\n\n* Newborns with major congenital anomalies\n* Newborns directly admitted to the NICU form delivery room","24 Hours",{"count":94,"type":23},75,[26],"Prolact CR (cream) is a fat supplement that is derived from pasteurized human donor milk. It has been utilized in babies who are born premature in the neonatal intensive care unit (NICU) setting to improve growth while avoiding cow milk exposure. There is no literature on the use of cream as a treatment for low blood glucose levels in newborns who are at risk. It is known that fat in human colostrum plays a vital role in providing energy, substrate, and stimulates gluconeogenesis. Gluconeogenesis is the process that helps in the sustainment of blood glucose. Dextrose gel that is used to treat low blood glucose levels helps in raising the blood glucose, but does not help in sustainment.\n\nThe objective of this pilot study is to evaluate the utility, feasibility, and acceptability of administering cream for the treatment of newborn low blood glucose levels in a couplet care unit. Investigators hypothesized that 3 ml\u002Fkg of cream (0.2 g\u002Fkg of carbohydrate and 0.75 g\u002Fkg of fat), if given in the place of 0.5 ml\u002Fkg (0.2 g\u002Fkg of carbohydrate) would increase and stabilize the blood glucose levels. Investigators also speculated that newborns would tolerate the cream with no adverse effects, and caregivers (nurses and parents) would find its use feasible and acceptable.\n\nParents of newborns with risk factors for hypoglycemia \\[born to mothers with diabetes, small for gestational age, large for gestational age, or late prematurity (35 to 37 weeks' gestation at birth) who intended to breastfeed exclusively will be approached to consent for the study either before or after delivery of the infant. Newborns with major congenital anomalies or those admitted immediately to the NICU after birth will be excluded.\n\nThe main questions hoping to answer\n\n1. What percentage of newborns receiving cream for treatment of hypoglycemia will need NICU admission for IV dextrose?\n2. How many median doses of cream are needed?\n3. What percentage of infants will be discharge exclusively feeding human milk from couplet care unit?\n4. What percentage of the surveys will show parent\u002Fnursing satisfaction with the product?",[29],"2025-10-15",{"date":100,"type":40},"2025-10-16",{"date":102,"type":40},"2024-10-14",{"date":104,"type":23},"2026-12-31",{"name":106,"class":47},"Baylor Research Institute",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100603237","accuracy-of-interstitial-continuous-glucose-sensors-in-neonates-100603237","NCT07133906","Accuracy of Interstitial Continuous Glucose Sensors in Neonates","Inclusion Criteria:\n\n* women aged 18 years or older\n* speaks English, Spanish, Portuguese, or Haitian Creole\n* pregnant \\>24 weeks gestation with singleton pregnancy\n\nExclusion Criteria:\n\n* known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff\n* plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island",{"count":114,"type":23},114,"OBSERVATIONAL","Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.",[29,118,119,120,121],"Gestational Diabetes","Maternal Obesity Complicating Pregnancy","Small-for-gestational Age","Large-for-gestational Age","2025-08-13",{"date":124,"type":40},"2025-08-21",{"date":126,"type":23},"2025-09",{"date":128,"type":23},"2027-06",{"name":130,"class":47},"Women and Infants Hospital of Rhode Island",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100392131","continuous-glucose-monitoring-in-at-risk-newborns-100392131","NCT04386005","Continuous Glucose Monitoring in At-Risk Newborns","Continuous Glucose Monitoring in At-Risk Newborns: A Feasibility Study","Inclusion Criteria:\n\n* At-risk newborns (\\\u003C48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:\n\n  1. Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)\n  2. Large for gestational age (LGA, \\>90th percentile \\[sex-specific\\])\n  3. Small for gestational age (SGA, \\\u003C10th percentile \\[sex-specific\\])\n  4. Late preterm (LPT, 34 0\u002F7 to 36 6\u002F7 weeks' gestation)\n* Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)\n\nExclusion Criteria:\n\n* Birth weight \\\u003C2kg\n* hypoxic-ischemic encephalopathy\n* a contraindication to oral feeding\n* abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)\n* chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally\n* infants who are not expected to survive or who are in extremis\n* additional risk of immunocompromise, including:\n\n  1. Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection\n  2. Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas\n  3. Systemic sepsis, viral syndromes\n  4. Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases\n  5. Abdominal wall defects","2 Weeks",{"count":140,"type":23},100,[26],"Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers \\[IDM\\], large \\[LGA\\] and small \\[SGA\\] for gestational age infants, and late preterm \\[LPT\\] infants) undergo a hypoglycemia screening protocol that involves numerous intermittent needle sticks to test glucose levels on bedside glucometers; however, continuous glucose monitoring (CGM, currently not approved for clinical use in babies), via a small sensor placed in the thigh (only 1 needle stick), would likely decrease pain while providing continuous glucose levels. This study will evaluate the feasibility, safety, and precision of CGM in at-risk newborns, and determine if this method would decrease the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling.\n\nAs part of regular medical care, participants will undergo intermittent blood glucose screening with heel sticks as per the current hospital standard of care protocol. Regular medical care involves checking the participant's blood glucose via heel stick every few hours using a bedside glucometer, with another heel stick to confirm low values in the laboratory. If the participant has low values, he\u002Fshe may be treated with oral glucose gel, feedings of breast milk or formula, or intravenous (IV) fluids in the Neonatal Intensive Care Unit (NICU). This research study involves placing a CGM device in addition to undergoing the current blood glucose screening protocol and treatment.\n\nAs soon as possible after birth, a continuous glucose monitoring device (Dexcom G7) will be placed on the participant's thigh by a research team member, and will blindly continuously record glucose levels that will be analyzed after discharge. Everyone who agrees to participate in this study will have placement of this experimental device.\n\nThe investigational device will stay in place for the same amount of time that a participant is undergoing blood glucose monitoring as per the current standard of care protocol, for a maximum of 7 days. A participant may need to have his\u002Fher blood glucose checked after 7 days for regular medical care (and not for research), because his\u002Fher glucose concentrations are still low. Being in the research study will not affect a participant's medical care, and will not affect how long he\u002Fshe needs blood glucose monitoring or treatment.\n\nA research team member will place and remove the CGM. Nurses will evaluate the site of the device for signs of irritation, infection, bleeding, and any other issues at least 3 times per day. After discharge from the hospital, data will be collected from the participant's medical record and participant's mother's medical record, including the participant's sex and birth weight, blood glucose values, details of feedings, treatments given for low glucose concentrations, and NICU admission data. Data that will be collected from the participant's mother's medical record includes age and race, prenatal data, medical history, and medication use. The participant's parents will be asked to fill out a short survey about their experience with this device when it is removed.",[29],[145,146],"blood glucose","continuous glucose monitor","2025-08-12",{"date":149,"type":40},"2025-08-15",{"date":151,"type":40},"2021-08-09",{"date":153,"type":23},"2026-06",{"name":155,"class":47},"Milton S. Hershey Medical Center",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":163,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":115,"phases":4,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":48},"100577131","blood-glucose-in-pregnant-non-diabetic-women-during-treatment-with-betamethasone-for-fetal-lung-maturation-100577131","NCT06794307","Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation","Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation","Inclusion Criteria:\n\n* Pregnant in gestational week 24+0 - 34+0 admitted with symptoms of threatened preterm birth:\n\n  * Premature contractions and shortening of the cervix, or\n  * Preterm premature rupture of membranes.\n* Treatment with betamethasone for fetal lung maturation is planned, or started (maximum 4 hours before inclusion)\n* Age over 18 years\n* Read and understand Danish\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Diabetes\n* Pre-existing maternal use of medications that affect glucose metabolism","FEMALE","18 Years",{"count":166,"type":23},25,"6 Months","In case of threatening preterm birth, it is standard to recommend treatment with betamethasone to accelerate fetal lung maturation. In pregnant women with diabetes, treatment with betamethasone can lead to significant hyperglycemia, which may cause hypoglycemia in the neonate. Changes in blood glucose in non-diabetic women are less investigated. In this study we aim to examine changes in maternal blood glucose levels in non-diabetic women, during treatment with betamethasone, by continuous glucose monitoring.\n\nHypotheses:\n\nAdministration of betamethasone induce significant hyperglycemia in non-diabetic pregnant women during treatment.",[170,171,29,172],"Preterm Birth","Hyperglycemia","Threatened Preterm Labor",[174,175,176,177],"Preterm birth","Betamethasone","Continuous glucose monitoring","Antenatal corticosteroids","2025-01-20",{"date":180,"type":40},"2025-01-27",{"date":182,"type":40},"2024-11-20",{"date":184,"type":23},"2026-01",{"name":186,"class":47},"University of Aarhus",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":48},"100397709","continuous-glucose-monitoring-in-infants-100397709","NCT04458649","Continuous Glucose Monitoring in Infants","Inclusion Criteria:\n\n* Mother at least 18 years of age\n* Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)\n* Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers\n\nExclusion Criteria:\n\n* Infants born small for gestational age (SGA)\n* Infant birth weight \\\u003C2.5 kg\n* Infant BMI \\\u003C10th percentile on Olsen chart\n* Infants born \\\u003C38 weeks gestation\n* Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound\n* Mother is non-English speaking","1 Hour","2 Hours",{"count":196,"type":23},200,"The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.",[29],"2024-07-01",{"date":201,"type":40},"2024-07-03",{"date":203,"type":40},"2020-10-01",{"date":205,"type":23},"2024-12-31",{"name":207,"class":47},"University of California, San Diego"]