Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity. Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is: 1. one source to higher health care costs (hospitalization, additional examinations) 2. Selection of the bacterial ecology of the newborn and neonatal services and 3. stress for the newborn and parents
NCT02858700 — Neonatal Bacterial Infection
Status: Completed
http://inclinicaltrials.com/neonatal-bacterial-infection/NCT02858700/
Efficacy of Intravenous Umbilical Cord Blood Infusion as Cell Therapy for Children With Autism Spectrum Disorder (ASD): Duke ACT
This is a single site, prospective, randomized, double-blind study of a single intravenous autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with Autism Spectrum Disorder (ASD). Participants will be randomly assigned to Sequence A, consisting of a single infusion of CB cells at baseline followed 6 months later by a single infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline followed 6 months later by an infusion of CB cells. All participants will ultimately be treated with CB cells at some point during the study. Participants with an available qualified autologous CB unit will receive autologous cells, and those without a suitable autologous CB unit available will receive cells from a ≥4/6 HLA-matched, ABO-matched allogeneic, unrelated donor CB unit from the Carolinas Cord Blood Bank. All infusions will be double-blinded. The primary outcomes will be assessed 6 months after the initial infusion in the sequence. Additional testing for secondary exploratory analyses will be performed at 12 months. Duration of study participation will be 12 months from the time of baseline infusion.
NCT02847182 — Autism Spectrum Disorder
Status: Completed
http://inclinicaltrials.com/autism-spectrum-disorder/NCT02847182/
Multi-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic Anemia
To assess whether ATG Combined With Cyclophosphamide and cord blood infusion can accelerate hematopoietic reconstruction in severe aplastic anemia patients and improve clinical curative effect and safety
NCT02838992 — Aplastic Anemia
Status: Not yet recruiting
http://inclinicaltrials.com/aplastic-anemia/NCT02838992/
Changes of Gas Values in Cord Blood Versus Time and Temperature
The pH levels of a neonatal at his birth are an important factor in establishing the connection between events that occurred during the actual time of birth, to the risk of a significant morbidity development in the future. Gas values in cord blood are measurable and represent the condition of the fetus close to the time of birth. Their level is one of the essential criteria which are used to define acute hypoxic event during birth. As the oxygen supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing. Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal blood acidosis. Many works connected the presence of cord blood acidosis to development of neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology, cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with negative neonatal outcome. This approach might be necessary when the case is legally controversial and there is a need to prove that umbilical cord gas values were normal at the prenatal period.
NCT02785367 — Abnormal; Birth
Status: Not yet recruiting
http://inclinicaltrials.com/abnormal-birth/NCT02785367/
The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia
Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy (IST). Study design: open-labed, prospective, multicenter, randomized control study Number of subjects: 60 each group Treatment: IST group: ATG (Thymoglobuline®, Genzyme) 3.5mg/kg/d×5d plus oral cyclosporine A (CSA) Cord blood transfusion group: In addition to the same dose and course of ATG and CSA , one unit of cord blood having no more than 2 HLA-A, B or DRB1 mismatches is transfused 24h after last dose of ATG administration.
NCT02745717 — Severe Aplastic Anemia
Status: Completed
http://inclinicaltrials.com/severe-aplastic-anemia/NCT02745717/
A Phase I-II Open-label Study of UM171 Expanded Cord Blood in a Fed-batch Culture System (UFCB-001) in Patients Who Need an Allogeneic Hematopoietic Stem Cell Transplant But Lack a Suitable Donor
Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients with blood cancers, but only 25% of transplant candidates have a sibling donor. A matched unrelated donor can be found for 60% of patients but this number is lower for non-Caucasians. Cord blood (CB), another source of stem cells, has major advantages over unrelated donors including immediate availability, better permissiveness in immune mismatches between donor and transplant recipient, better availability for non-Caucasians, and less graft versus host disease, a complication frequently seen after transplant which negatively affects quality of life. Unfortunately, the use of CB is still limited in adults because of the small number of stem cells. UM171, a molecule with hematopoietic stem cell expansion properties, has been shown to increase cord blood stem cells 13 fold. In this trial, Investigators will use UM171 treated CB in patients who need a transplant but lack an acceptable donor.This protocol seeks to test the safety of CB cells expanded with UM171, and to determine the kinetics of engraftment as well as the minimal cord blood unit cell dose that when expanded achieves prompt engraftment.
NCT02668315 — Hematologic Malignancy
Status: Completed
http://inclinicaltrials.com/hematologic-malignancy/NCT02668315/
A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
NCT02612155 — Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Status: Completed
http://inclinicaltrials.com/moderate-or-severe-hypoxic-ischemic-encephalopathy-in-newborns/NCT02612155/
A Multi-Centre Safety and Efficacy Study of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonates Encephalopathy in China
This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia,which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.
NCT02605018 — Cerebral Infarction
Status: Not yet recruiting
http://inclinicaltrials.com/cerebral-infarction/NCT02605018/
Assessment of the Safety of Allogeneic Umbilical Cord Blood Infusions in Children With Cerebral Palsy
This study is a single site, phase I, prospective study of the safety of intravenous sibling cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will be treated with sibling cord blood cells. The first six will receive cord blood cells from an HLA-matched sibling. The following nine subjects will receive cord blood cells from an HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will be six months from the time of the cord blood infusion.
NCT02599207 — Cerebral Palsy
Status: Completed
http://inclinicaltrials.com/cerebral-palsy/NCT02599207/
A Multi-Centre Safety and Efficacy Study of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonates Encephalopathy in China
This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.
NCT02551003 — Cerebral Infarction
Status: Withdrawn
http://inclinicaltrials.com/cerebral-infarction/NCT02551003/