In-Utero Vascular Accidents in Neonates from COVID-19 Infected MothersThis study plans to learn more about how COVID-19 infection during pregnancy may have direct effects on the developing baby 30 days after birth. Protocol #: 20-1399 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Role of Kv7 channels in the regulation of placental arteries vasoreactivity in mothers with Long QT syndrome (LQTS) Types 1 and 2Protocol #: 20-0226 Location: Childrens Hospital Colorado |
Multi-center chart review of pregnant women undergoing fetoscopic laser surgery (FLS) for Twin-Twin Transfusion syndrome (TTTS) with a short cervical length.Protocol #: 20-0189 Location: Childrens Hospital Colorado |
Feasibility and Limited Efficacy Trial of a Cognitive Behavioral Intervention to Reduce Procedural Anxiety Among Woman with High Risk Pregnancies with Scheduled Cesarean DeliveriesProtocol #: 19-1896 Location: Childrens Hospital Colorado |
Effects of prenatal antibiotics on the infant gut microbiomeThree different bacteria of the infant gut microbiome will be obtained through collection of infant stool samples at birth and at 6 weeks of age. These bacteria will be measured and comparisons made between infants whose mothers took antibiotics during pregnancy and infants whose mothers did not take antibiotics during pregnancy. Pregnant women will be recruited between their 35-37th weeks of pregnancy and will complete two surveys, the first prenatally and the second at 6-weeks postpartum. Protocol #: 19-2288 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Role of vascular/cardiac biomarkers in amniotic fluid of patients with Twin-Twin Transfusion Syndrome (TTTS)Protocol #: 14-1413 Location: Childrens Hospital Colorado |
NAFTNet Prenatal Diagnosis of Isolated Aqueductal StenosisProtocol #: 18-1076 Location: Childrens Hospital Colorado |
A Safety Study of Intravenous Infusion of Bone Marrow Mesenchymal Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for Bronchopulmonary DysplasiaA multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of GA at high risk for BPD Protocol #: 18-2881 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
CU Faces of Hope-Genetics of Craniofacial and Dental Development Research StudyThis study plans to collect samples to create a database of patients with various syndromes that affect the way bones of the face are formed, termed “craniofacial”. These samples will support a new research program, named CU Faces of Hope, which involves a team of researchers and doctors who will work together toward a goal of better understanding facial development and gain knowledge about your specific syndrome. Samples, such as blood, DNA, and cells, will be stored for future approved research. The reason for collecting both health information and blood/tooth samples from the same person is to look at relationships between physical symptoms, behavior, genes, and parts of the blood. We are also asking parents and siblings of people with these various craniofacial associated syndromes to join the study. Having information available from family members can help researchers look at differences between people who have a syndrome and those who do not. Protocol #: 18-1916 Location: Childrens Hospital Colorado |
A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTSThe primary objective of this study is: To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life. Protocol #: 18-1121 Location: University of Colorado Hospital |
PLACENTAL PROTEINS AND PREMATURITY (P3 STUDY)This study plans to learn more about why babies born prematurely sometimes can have problems with infections, breathing, feeding, vision, and brain function. Protocol #: 18-0637 Location: University of Colorado Hospital |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)Protocol #: 18-0461 Location: Childrens Hospital Colorado |
Amniotic Fluid-Derived Cardiomyocyte Model to Investigate Mechanotransduction in CardiomyocytesProtocol #: 17-2296 Locations: Childrens Hospital Colorado; University of Colorado Hospital |
Assessment of NAAT to Determine GBS Status After Initiation of Intrapartum Antibiotic ProphylaxisThis study plans to learn more about a new method of testing for GBS, to see if it can be reliably used after antibiotics have been started. Protocol #: 17-2177 Location: University of Colorado Hospital |
Electronic Cigarette Use During PregnancyProtocol #: 17-2033 Locations: CU John C. Hobbins Perinatal Center; CU Parker Perinatal Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital |
A Pragmatic Multicenter Randomized Trial: Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy (CHAP Project)Protocol #: 17-0914 Locations: Denver Health Medical Center; University of Colorado Hospital |
Effects of high altitude on AMPK activationThis study plans to learn more about differences in pregnancy between high and low altitudes in Colorado. Participants will be asked to complete ultrasounds and provide blood samples throughout pregnancy, and provide samples such as cord blood at the time of delivery. Protocol #: 14-2178 Locations: CTRC-perinatal; CU John C. Hobbins Perinatal Center; University of Colorado Hospital |
Double-blind Trial of Phosphatidylcholine Supplementation during Pregnancy: Impact on Attention and Social Withdrawal at 4 years of AgePrimary Objective: Assess whether parental rating of problems on the Attention and Social Withdrawal indices of the Child Behavior Checklist at 4 years of age for children of mothers who received prenatal phosphatidylcholine supplementation are lower, compared to children whose mothers received placebo. Protocol #: 16-1510 Locations: Colorado Research Center; Denver Health Medical Center; Department Specific Free Standing Clinic; University of Colorado Hospital |