Search Clinical Trials
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Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory...
Children's Oncology Group
Recurrent B Acute Lymphoblastic Leukemia
Recurrent B Lymphoblastic Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory B Lymphoblastic Lymphoma
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients
with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come
back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a... expand
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Type: Interventional Start Date: Jun 2017 |
Clinical and Laboratory Study of Methylmalonic Acidemia
National Human Genome Research Institute (NHGRI)
Organic Acidemia
Methylmalonic Acidemia
Inborn Errors of Metabolism
Methylmalonic acidemia (MMA), one of the most common inborn errors of organic acid
metabolism, is heterogeneous in etiology and clinical manifestations. Affected patients with
cblA, cblB and mut classes of MMA are medically fragile and can suffer from complications
such as... expand
Methylmalonic acidemia (MMA), one of the most common inborn errors of organic acid metabolism, is heterogeneous in etiology and clinical manifestations. Affected patients with cblA, cblB and mut classes of MMA are medically fragile and can suffer from complications such as metabolic stroke or infarction of the basal ganglia, pancreatitis, end stage renal failure, growth impairment, osteoporosis, and developmental delay. The frequency of these complications and their precipitants remain undefined. Furthermore, current treatment protocol outcomes have continued to demonstrate substantial morbidity and mortality in the patient population. Increasingly, solid organ transplantation (liver, and/or kidney) has been used to treat patients. Disordered transport and intracellular metabolism of vitamin B12 produces a distinct group of disorders that feature methylmalonic acidemia as well as (hyper)homocysteinemia. These conditions are named after the corresponding cellular complementation class (cblC, cblD, cblF, cblJ and cblX) and are also heterogenous, clinically and biochemically. The genetic disorders underlying cblE and cblG feature an isolated impairment of the activity of methionine synthase, a critical enzyme involved in the conversion of homocysteine to methionine and these disorders feature (hyper)homocysteinemia. Lastly, a group of patients can have increased methylmalonic acid and/or homocysteine in the blood or urine caused by variant(s)in recently identified (ACSF3) and unknown genes. In this protocol, we will clinically evaluate patients with methylmalonic acidemia and cobalamin metabolic defects. Routine inpatient admissions will last up to 4-5 days and involve urine collection, blood drawing, ophthalmological examination, radiological procedures, MRI/MRS, skin biopsies in some, and developmental testing. In a subset of patients who have or will receive renal, hepato- or hepato-renal transplants or have an unusual variant or clinical course and have MMA, a lumbar puncture to examine CSF metabolites will be performed. In this small group of patients, CSF metabolite monitoring may be used to adjust therapy. The study objectives will be to further delineate the spectrum of phenotypes and characterize the natural history of these enzymopathies, query for genotype/enzymatic/phenotype correlations, search for new genetic causes of methylmalonic acidemia and/or homocysteinemia, identify new disease biomarkers and define clinical outcome parameters for future clinical trials. The population will consist of participants previously evaluated at NIH, physician referrals, and families directed to the study from clinicaltrials.gov as well as the Organic Acidemia Association, Homocystinuria Network America and other national and international support groups. Most participants will be evaluated only at the NIH Clinical Center. However, if the NIH team decides that a patient under the age of 2 years is a candidate subject for this research protocol, that patient may enroll at the Children s National Medical Center (CNMC) site, pending approval by Dr Chapman, the Principal Investigator of the CNMC location Individuals may also enroll in the tissue collection only part of the study at the UPMC Children s Hospital of Pittsburgh or share medical history and clinical data via telemedicine visits remotely. Outcome measures will largely be descriptive and encompass correlations between clinical, biochemical and molecular parameters. Type: Observational Start Date: Jun 2004 |
Pediatric Percutaneous Ultrasound Gastrostomy Technique
CoapTech
Gastrostomy
Gastrostomy Complications
Pediatric Disorder
Ultrasound
The purpose of this research study is to test a new device called the PUMA-G Pediatric
System. The research will measure if the device works well to safely aid doctors placing
gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational
device that... expand
The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube. Type: Interventional Start Date: Jul 2023 |
Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis
St. Jude Children's Research Hospital
Hemophagocytic Lymphohistiocytosis
This study is a multi-site Phase Ib/II, 2-arm non-randomized clinical trial to determine the
efficacy and tolerability of a response-adapted regimen combining ruxolitinib, dexamethasone,
and etoposide as Frontline therapy for patients with newly diagnosed hemophagocytic
lymphohistiocytosis... expand
This study is a multi-site Phase Ib/II, 2-arm non-randomized clinical trial to determine the efficacy and tolerability of a response-adapted regimen combining ruxolitinib, dexamethasone, and etoposide as Frontline therapy for patients with newly diagnosed hemophagocytic lymphohistiocytosis (HLH) or as Salvage therapy for patients with relapsed/refractory HLH. Primary Objective - To determine the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with newly diagnosed HLH. Secondary Objectives - To describe the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with relapsed/refractory HLH. - To describe the overall response and outcome for patients with newly diagnosed or relapsed/refractory HLH who are treated with this response-adapted ruxolitinib-containing regimen. Exploratory Objectives - To estimate the pharmacokinetic (PK) parameters of ruxolitinib, assess covariates of ruxolitinib pharmacokinetics, and test whether the drug's effectiveness is correlated with systemic drug exposure. - To query specific immunologic biomarkers and determine whether the levels of these biomarkers correlate with disease response and outcome. Type: Interventional Start Date: Jul 2021 |
International Rare Brain Tumor Registry
Children's National Research Institute
Astroblastoma
BCOR ITD Sarcoma
CNS Sarcoma
Unclassified Tumor, Malignant
The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand
rare brain tumors through the collection of biospecimens and matched clinical data of
children, adolescents, and young adult patients diagnosed with rare brain tumors.
expand
The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors. Type: Observational [Patient Registry] Start Date: Jan 2023 |
Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma
University of California, San Francisco
Medulloblastoma
Medulloblastoma, Childhood
Medulloblastoma Recurrent
The current study will use a new treatment approach based on the molecular characteristics of
each participant's tumor. The study will test the feasibility of performing real-time drug
screening on tissue taken during surgery, and of having a specialized tumor board assign a... expand
The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility of performing real-time drug screening on tissue taken during surgery, and of having a specialized tumor board assign a treatment plan based on the results of this screening and genomic sequencing. The aim of this trial is to allow every child and young adult with medulloblastoma to receive the most effective and least toxic therapies currently available, and will pave the way for improved understanding and treatment of these tumors in the future. Type: Interventional Start Date: Feb 2022 |
Orphan Europe Carbaglu® Surveillance Protocol
Nicholas Ah Mew
N-acetylglutamate Synthase (NAGS) Deficiency
The purpose of this study is to conduct post-marketing surveillance of carglumic acid
(Carbaglu) to obtain long-term clinical safety information. Carglumic acid was approved by
the United States Food and Drug Administration (FDA) for treatment of acute hyperammonemia
due to... expand
The purpose of this study is to conduct post-marketing surveillance of carglumic acid (Carbaglu) to obtain long-term clinical safety information. Carglumic acid was approved by the United States Food and Drug Administration (FDA) for treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. Much of the FDA-required data is already collected through the Longitudinal Study of Urea Cycle Disorders (RDCRN Protocol #5101). This study will collect additional data on adverse events (interim events), adverse reactions, pregnancy, and fetal outcomes. Type: Observational [Patient Registry] Start Date: Apr 2012 |
A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for Primary Central...
Children's Oncology Group
Central Nervous System Carcinoma
This phase III trial compares memantine to usual treatment in treating patients with primary
central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the
brain known to contribute to a decline in cognitive function. Giving memantine may make a... expand
This phase III trial compares memantine to usual treatment in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors. Type: Interventional Start Date: May 2022 |
Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
Children's Oncology Group
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
This trial studies the side effects of enasidenib and to see how well it works in treating
patients with acute myeloid leukemia that has come back after treatment (relapsed) or has
been difficult to treat with chemotherapy (refractory). Patients must also have a specific
genetic... expand
This trial studies the side effects of enasidenib and to see how well it works in treating patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for cell growth. Type: Interventional Start Date: Aug 2023 |
The Myelin Disorders Biorepository Project
Children's Hospital of Philadelphia
Leukodystrophy
White Matter Disease
Leukoencephalopathies
4H Syndrome
Adrenoleukodystrophy
The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data
and biological samples from leukodystrophy patients worldwide to support ongoing and future
research projects. The MDBP is one of the world's largest leukodystrophy biorepositories,... expand
The Myelin Disorders Biorepository Project (MDBP) seeks to collect and analyze clinical data and biological samples from leukodystrophy patients worldwide to support ongoing and future research projects. The MDBP is one of the world's largest leukodystrophy biorepositories, having enrolled nearly 2,000 affected individuals since it was launched over a decade ago. Researchers working in the biorepository hope to use these materials to uncover new genetic etiologies for various leukodystrophies, develop biomarkers for use in future clinical trials, and better understand the natural history of these disorders. The knowledge gained from these efforts may help improve the diagnostic tools and treatment options available to patients in the future. Type: Observational [Patient Registry] Start Date: Dec 2016 |
Childhood Cancer Survivor Study
St. Jude Children's Research Hospital
Cancer
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer
and its associated therapies. A retrospective cohort study will be conducted through a
multi-institutional collaboration, which will involve the identification and active follow-up... expand
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes. Type: Observational Start Date: Jan 1995 |
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
University of Alabama at Birmingham
Respiratory Syncytial Virus Infections
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM)
during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be
beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.
expand
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway. Type: Interventional Start Date: Feb 2022 |
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult...
InSightec
Benign Centrally-Located Intracranial Tumors
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop
data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial
tumors which require clinical intervention in pediatric and young adult subjects.
Indication... expand
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible. Type: Interventional Start Date: Feb 2017 |
The Pediatric Anesthesia Quality Improvement Project
The Society for Pediatric Anesthesia
Surgery
Anesthesia
Children
The Study is designed to collect information about adverse events that occur in children
undergoing anesthesia in participating hospitals. Demographic information will be collected
on all anesthetics. An analysis of each adverse event will be performed and entered into the... expand
The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events. Type: Observational [Patient Registry] Start Date: Feb 2008 |
Evaluation of The Food Allergy Mastery Program
Children's National Research Institute
Food Allergy in Children
The proposed research project will evaluate a novel behavioral intervention that promotes
early adolescent food allergy self-management and adjustment through 1) food allergy
education, 2) problem-solving, communication, assertiveness, and anxiety management skill
building,... expand
The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support. Type: Interventional Start Date: Jun 2023 |
Multi-antigen T Cell Infusion Against Neuro-oncologic Disease
Catherine Bollard
Brain Tumor
This Phase I dose-escalation trial is designed to determine the safety and feasibility of
rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in
patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent,... expand
This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B). Pediatric and adult patients who have high-risk CNS tumors known to typically have positivity for one or more Tumor Antigen Associated (TAA) (WT1, PRAME and/or Survivin) will be eligible. TAA-T will all be generated from patient peripheral blood mononuclear cells (PBMC). Group A patients (DIPG): The first TAA-T dose will be infused any time 14 days or more after completion of radiotherapy. Group B patients (other recurrent/progressive/refractory CNS tumors): The first TAA-T dose will be infused any time 14 days or more after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria. Type: Interventional Start Date: Dec 2018 |
Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
Catherine Bollard
Viral Infection
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV)
injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and
Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with... expand
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al. Type: Interventional Start Date: Jan 2018 |
Study of Kidney Tumors in Younger Patients
Children's Oncology Group
Adult Cystic Nephroma
Anaplastic Kidney Wilms Tumor
Angiolipoma
Cellular Congenital Mesoblastic Nephroma
Classic Congenital Mesoblastic Nephroma
This research trial studies kidney tumors in younger patients. Collecting and storing samples
of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may
help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify... expand
This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. Type: Observational Start Date: Feb 2006 |
A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors
Children's National Research Institute
Solid Tumors
Soft Tissue Sarcoma
Ewing Sarcoma
Malignant Epithelial Neoplasm
Rhabdomyosarcoma
This is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with
refractory/relapsed solid tumors.
expand
This is a pilot study of LTLD with MR-HIFU hyperthermia followed by ablation in subjects with refractory/relapsed solid tumors. Type: Interventional Start Date: Nov 2022 |
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
Children's National Research Institute
End Stage Renal Disease
An observational cohort study will be conducted to non-invasively investigate central blood
pressure and pulse wave velocity in children with kidney disease and controls. Using an
oscillometric monitor, the investigators aim to non-invasively obtain the central blood
pressure... expand
An observational cohort study will be conducted to non-invasively investigate central blood pressure and pulse wave velocity in children with kidney disease and controls. Using an oscillometric monitor, the investigators aim to non-invasively obtain the central blood pressure and pulse wave velocity (PWV), or arterial stiffness, of children with kidney disease. The investigators will also enroll age- and race-matched healthy controls and measure the same parameters for comparison. In addition, the investigators will measure PWV by standard arterial tonometry method in a subset of patients. Type: Observational Start Date: Jul 2021 |
Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Children's National Research Institute
Sickle Cell Disease
Attention Deficit
Cognitive Deficit in Attention
Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning
(often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx
(Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic
attentional-control... expand
Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning (often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx (Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic attentional-control training program designed to treat attention problems in youth. Users access EndeavorRx on a tablet device for 25-30 minutes each day, 5 days per week, for 4 weeks. The program involves training in a game-like environment that repeatedly challenges attentional-control abilities and adapts to user performance, becoming more difficult over time as performance improves. This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy. Type: Interventional Start Date: Dec 2022 |
PedBot Ankle Rehablitation
Children's National Research Institute
Cerebral Palsy
The primary objective of the study is to determine engagement with use and adherence to a
home exercise program with our PedBotHome ankle rehabilitation device. We will place the
device in the home for 90 days and consider the study a success if used for at least 30
minutes... expand
The primary objective of the study is to determine engagement with use and adherence to a home exercise program with our PedBotHome ankle rehabilitation device. We will place the device in the home for 90 days and consider the study a success if used for at least 30 minutes a day for at least 3 days a week during this period. Type: Observational Start Date: Jul 2022 |
Measuring Analgesic Interventions
Julia Finkel
Pain
It is generally recognized that pain assessment and management especially in newborns,
children and other nonverbal populations is an unmet need. According to the American Medical
Association, "the pediatric population is at risk of inadequate pain management, with
age-related... expand
It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population. Type: Observational Start Date: Oct 2018 |
T CELL THERAPY OPPOSING NOVEL COVID-19 INFECTION IN IMMUNOCOMPROMISED PATIENTS
Children's National Research Institute
SARS-CoV-2 Infection
This is an open label, phase I dose-escalation study to evaluate the safety of
coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in
immunocompromised patients following hematopoietic stem cell transplantation (HSCT).
Participants will receive... expand
This is an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and <4 months after HSCT). In this dose escalation trial, three doses (1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and <80 years) HSCT recipients (Arm A) and pediatric (≥12 years of age and <18 years) HSCT recipients (Arm B), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity. Type: Interventional Start Date: Oct 2021 |
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
The Hospital for Sick Children
Heart Block Complete
Heart Block Second Degree
Few studies are specifically designed to address health concerns that are already relevant
during pregnancy. The consequence is a lack of evidence on best clinical practice. This
includes mothers and their babies when pregnancy is complicated by an abnormally slow heart
rate... expand
Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research. Type: Observational [Patient Registry] Start Date: Jan 2020 |
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