Clinical trials: Sudden Infant Death
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
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 II, Metabolic Diseases
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
This is phase 2/3 study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the investigational product GNR-055 in MPS II (Hunter syndrome) patients of different age groups.
- Trial name
- NCT05208281
- Testing
- GNR-055 1.0-2.0-3.0 mg/kg, GNR-055 2.0 mg/kg, GNR-055 3.0 mg/kg
- Where
- 5 sites in Russia
- Volunteers
- 32 people
- Sponsor
- AO GENERIUM
SIDS
JessieHug Feasibility and Usability Assessment
The goal of this clinical trial is to evaluates the usability, tolerability, and clinical accuracy of the JessieHug device, a wearable medical device for newborns and infants that collects physiological data.
- Trial name
- NCT06466148
- Testing
- JessieHug
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
MLD, Krabbe Disease
Longitudinal Study of Neurodegenerative Disorders
The purpose of this study is to understand the course of rare genetic disorders that affect the brain. This data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the…
- Conditions
- MLD, Krabbe Disease, ALD, MPS I
- Trial name
- NCT03333200
- Testing
- Palliative Care, Hematopoetic Stem Cell Transplantation
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- University of Pittsburgh
Health Behavior
Reduce African-American Infant Mortality
The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment.
- Trial name
- SIDS (NCT01361880)
- Testing
- Reduce Infant Mortality
- Where
- United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Sudden Infant Death
Investigation of the Genetic Diseases in Infants With Unknown Cause of Death
Sudden infant death syndrome (SIDS) is a disease of an infant under one year of age, whose sudden death occurred unexpectedly, which the cause of death cannot be determined despite macro-autopsy, and toxicological, pathological…
- Trial name
- SIDS (NCT06060249)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Ankara University
Sudden Infant Death
Generations in Families Talking Safe Sleep
Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek…
- Trial name
- GIFTSS (NCT03186469)
- Testing
- Safety Baby shower, Standard of Care
- Where
- United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Arkansas Children's Hospital Research Institute
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
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Mucopolysaccharidosis II
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity…
- Trial name
- NCT04007536
- Testing
- No Intervention
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 18 people
- Sponsor
- Denali Therapeutics Inc.
Sudden Infant Death
Influence of Pacifiers on Breastfeeding Duration
The purpose of this study is to determine if the introduction of pacifier use to infants at 2 weeks of age, once breast feedings are well established, will affect the incidence and duration of successful breastfeedings.
- Trial name
- NCT00306956
- Testing
- offer a pacifier
- Where
- 5 sites in Argentina
- Volunteers
- 1,021 people, healthy volunteers welcome
- Sponsor
- Fundacion para la Salud Materno Infantil
Sudden Infant Death Syndrome
Changes in Sleep Patterns and Stress in Infants Entering Child Care
When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS).
- Trial name
- NCT01265277
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Rachel Moon, MD
Apparent Life-Threatening Event in Infants Under One Year of Age
Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors
Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological complications or to sudden death. In such situations, cardio-pediatricians and intensive care physicians have no specific diagnosis or…
- Trial name
- iALTE (NCT03278977)
- Testing
- Blood sample for specific analyzes
- Where
- 4 sites in France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Strasbourg, France
Hunter Syndrome, Mucopolysaccharidosis II
Biomarkers for Hunter Syndrome
International, multicenter, observational, longitudinal study to establish Hunter Syndrom biomarker/s and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
- Conditions
- Hunter Syndrome, Mucopolysaccharidosis II, Hunter's Syndrome, Mild Form, Hunter's Canal Syndrome
- Trial name
- BioHunter (NCT01330277)
- Where
- 4 sites in Mexico
- Volunteers
- 11 people
- Sponsor
- CENTOGENE GmbH Rostock
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
High Risk Pregnancy, Congenital Heart Disease
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome.
- Conditions
- High Risk Pregnancy, Congenital Heart Disease, Fetal Hydrops, Twin Monochorionic Monoamniotic Placenta
- Trial name
- NCT03775954
- Testing
- Fetal Magnetocardiogram and Neonatal Electrocardiogram, Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
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
Sudden Infant Death
The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study
Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk…
- Trial name
- NCT05823051
- Testing
- VASIDS-TP and Counseling Practice
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dilara Aydin Tozlu
Mucopolysaccharidosis II
Long-term Follow-Up for RGX-121
RGX-121-5101 is an observational long-term follow-up study to the RGX-121-101 or RGX-121-1102 studies where participants received RGX-121, a gene therapy intended to deliver a functional copy of the iduronate-2-sulfatase gene…
- Trial name
- NCT04597385
- Testing
- Long-term Follow-Up
- Where
- 4 sites in United States, Brazil
- Volunteers
- 27 people
- Sponsor
- REGENXBIO Inc.