Clinical trials: Sudden Infant Death
Mucopolysaccharidosis Type II (MPS II)
RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is designed to deliver a functional copy of the iduronate-2-sulfatase (IDS) gene to the central nervous system.
- Trial name
- NCT04571970
- Testing
- RGX-121
- Where
- 2 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- REGENXBIO Inc.
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
Mucopolysaccharidosis Type I, Mucopolysaccharidosis Type II
Longitudinal Studies of Brain Structure and Function in MPS Disorders
Neurobehavioral function and quality of life are compromised in many patients with mucopolysaccharidosis (MPS) disorders. The long-term goals of this research are to: 1) more accurately inform patients/parents regarding potential…
- Conditions
- Mucopolysaccharidosis Type I, Mucopolysaccharidosis Type II, Mucopolysaccharidosis Type VI, Mucopolysaccharidosis Type IV
- Trial name
- NCT01870375
- Where
- 4 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- University of Minnesota
Sudden Infant Death
Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program
This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a…
- Trial name
- NCT03392727
- Testing
- Study Box, Community Box, Education Session
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
Stillbirths, Sudden Infant Death
Magnetic Resonance Imaging Autopsy Study
The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and…
- Trial name
- MARIAS (NCT01417962)
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Thayyil, Sudhin
Sudden Unexplained Infant Death, Child Rearing
Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care
The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit.
- Conditions
- Sudden Unexplained Infant Death, Child Rearing, Literacy
- Trial name
- NCT04031235
- Testing
- Sleep Baby, Safe and Snug, Read Baby, Every Day
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- HSCT+RIC (NCT01962415)
- Testing
- Hydroxyurea, Alemtuzumab, Fludarabine
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Paul Szabolcs
Breastfeeding, SUID
Social Media and Risk Reduction Teaching-Enhanced Reach
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers…
- Conditions
- Breastfeeding, SUID, SIDS
- Trial name
- SMARTER (NCT04387552)
- Testing
- Prenatal Safe Sleep Mobile Health (mHealth) Messaging, Prenatal Breastfeeding Mobile Health (mHealth) Messaging, Postnatal Safe Sleep Mobile Health (mHealth) Messaging
- Where
- United States
- Volunteers
- 2,093 people
- Sponsor
- Boston University
MPS II, Mucopolysaccharidosis II
MPS II Immunophenotyping
The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses…
- Conditions
- MPS II, Mucopolysaccharidosis II, Hunter Syndrome
- Trial name
- NCT04976231
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Duke University
SIDS, Infant Development
Improving Infant Sleep Safety With the Electronic Health Record
This research is being done to find out if individualized feedback provided to parents on safe infant sleep can improve safety. This will be accomplished by having parents send photographs of their baby sleeping through the…
- Trial name
- NCT03662048
- Testing
- Safe
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Sudden Death in Children
Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant
It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom.
- Trial name
- NCT03934242
- Testing
- Questionnaire on new born's bedding
- Where
- France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- CHU de Reims
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
OBJECTIVES: I. Describe the psychosocial response of parents and caretakers who learn cardiopulmonary resuscitation (CPR) techniques for infants at high risk for respiratory or cardiac arrest. II.
- Conditions
- Pulmonary Hypertension, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome
- Trial name
- NCT00004805
- Testing
- CPR instruction
- Volunteers
- 500 people
- Sponsor
- National Center for Research Resources (NCRR)
MPS II, Hunter Syndrome (MPS II)
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients…
- Conditions
- MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase
- Trial name
- NCT07344376
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- GC Biopharma Corp
Infant Death, Infant Care
Determining the Effect of Midwife-Led Safe Infant Care Training for Pregnant Women on Awareness of Sudden Infant Death Syndrome and Home Accidents
This project is a pioneering study in determining the impact of midwife-led safe infant care training for pregnant women on awareness of sudden infant death syndrome (SIDS) and home accidents.
- Conditions
- Infant Death, Infant Care, Midwifery, Education
- Trial name
- Infant Care (NCT07346482)
- Testing
- Education
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Cukurova 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
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
Infant Death, Sudden Infant Death
Get Social Media and Risk-Reduction Training
This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration…
- Trial name
- GETSMART (NCT06618586)
- Testing
- TodaysBaby
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- University of Virginia
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.
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