Clinical trials: SIDS
MPS II, Hunter Syndrome (MPS II)
RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system.
- Trial name
- NCT07236606
- Testing
- RGX-121-3102
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- REGENXBIO Inc.
Infant Safe Sleep Practices, SIDS
Infant Safe Sleep in Pediatric Emergency Depratment
Safe sleep recommendations from the American Academy of Pediatrics (AAP) are designed to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths.
- Trial name
- NCT07779512
- Testing
- Safe Sleep Education, Behavior habit tracking
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- State University of New York at Buffalo
Sudden Infant Death Syndrome
Parental Knowledge and Beliefs About Infant Sleep Position
In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months.
- Trial name
- NCT00005567
- Testing
- Parental knowledge and beliefs about infant sleep position
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)
Sudden Unexpected Infant Death, Air Pollution, Pesticides
Environmental Exposures and Sudden Unexpected Infant Death
This project is a descriptive study designed to identify the exposure of infants who died of MIN to ambient air pollutants, and to measure pesticide concentrations in biological matrices (hair, serum, LCS) within a sample from…
- Trial name
- ExpoMIN (NCT06708793)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Nantes University Hospital
Intensive Care (ICU), Intensive Care Unit (ICU) Admission
Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
Intensive Care Unit (ICU) represents a high-level healthcare and expensive resource in hospitals. The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been…
- Conditions
- Intensive Care (ICU), Intensive Care Unit (ICU) Admission, Intensive Care Unit Survivors, SID
- Trial name
- NCT07768410
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Saint Camillus International University of Health Sciences
SID, Feeding Disorder
Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the…
- Conditions
- SID, Feeding Disorder, SPD
- Trial name
- NCT02040688
- Where
- Israel
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Mucopolysaccharidosis (MPS), Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter…
- Trial name
- NCT05494593
- Testing
- ELAPRASE, Rituximab, Methotrexate
- Where
- 8 sites in United States
- Sponsor
- Takeda
Sudden Infant Death Syndrome
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants.
- Trial name
- SIDS (NCT01361893)
- Testing
- Lifestyle Counseling
- Where
- United States
- Volunteers
- 616 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Safe Sleep Education, SUID
Social Media and Risk-reduction Training for Preterm Infant Care Practices
SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants.
- Conditions
- Safe Sleep Education, SUID, Sudden Infant Death Syndrome (SIDS)
- Trial name
- SMART Preemie (NCT07420686)
- Testing
- Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign, Safe Sleep TodaysNICUBaby videos and messages
- Where
- United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Sudden Infant Death, Sudden Unexplained Infant Death
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent…
- Trial name
- NCT05503771
- Testing
- ISA-MI, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Mucopolysaccharidoses
Carotid Structure and Function in MPS Syndromes: A Multicenter Study of the Lysosomal Disease Network
Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies, and they have been linked to heart health complications.
- Trial name
- NCT01586871
- Where
- 2 sites in United States
- Volunteers
- 1,147 people
- Sponsor
- University of Minnesota
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC
This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- PRO-RIC (NCT04528355)
- Testing
- data collection
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paul Szabolcs
Stillbirth, Newborn Death
The Paediatric Virtual Autopsy Trial
In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death.
- Conditions
- Stillbirth, Newborn Death, Sudden Infant Death
- Trial name
- NCT01888380
- Testing
- Minimally invasive, virtual autopsy, Conventional autopsy
- Where
- 4 sites in Switzerland
- Volunteers
- 105 people
- Sponsor
- University of Zurich
Sudden Infant Death Syndrome
The Effect of the Use of Mobile App
This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death…
- Trial name
- NCT07032402
- Testing
- Education and Counseling, Standard Care
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Amasya University
Sudden Infant Death
Infant Care Practices Study
This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of…
- Trial name
- ICP (NCT03494621)
- Testing
- Protecting Babies While they Sleep Curriculum
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Avera McKennan Hospital & University Health Center
Mucopolysaccharidosis II
To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients
- Trial name
- NCT01301898
- Testing
- GC1111_0.5mg/kg, GC1111_1.0mg/kg, Elaprase_0.5mg/kg
- Where
- South Korea
- Volunteers
- 31 people
- Sponsor
- Green Cross Corporation
Mucopolysaccharidosis Type I (MPS I), Mucopolysaccharidosis Type II (MPS II)
Lysosomal Storage Disease: Health, Development, and Functional Outcome Surveillance in Preschool Children
Hypothesis: Children diagnosed with a lysosomal disease will exhibit developmental, adaptive, and behavioral strengths and difficulties depending upon 1) biomedical risk factors (i.e.
- Conditions
- Mucopolysaccharidosis Type I (MPS I), Mucopolysaccharidosis Type II (MPS II), Mucopolysaccharidosis Type III (MPS III), Mucopolysaccharidosis Type VI (MPS VI)
- Trial name
- NCT01938014
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- University of Chicago
Hunter Syndrome
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued…
- Trial name
- NCT05795361
- Testing
- Idursulfase-IT
- Where
- 22 sites in United States, Australia and 3 more
- Sponsor
- Takeda
African American Infant Sleep Beliefs and Practices
Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and…
- Trial name
- PrAAIS (NCT01707173)
- Testing
- Tailored education, Standard Education
- Where
- United States
- Volunteers
- 735 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Hunter Syndrome
Long-term Evaluation on Height and Weight in Patients With MPS II Who Started Treatment at < 6 Years of Age
This long-term study will provide Elaprase treatment to children enrolled in this study and will utilize data from both enrolled patients and Hunter Outcome Survey (HOS) patient registry data to conduct the primary growth…
- Trial name
- NCT02455622
- Testing
- Elaprase for intravenous (IV) infusion
- Where
- 8 sites in United States, Dominican Republic and 6 more
- Volunteers
- 21 people
- Sponsor
- Shire