Clinical trials: Sudden Infant Death
Mucopolysaccharidosis II
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous…
- Trial name
- NCT06075537
- Testing
- tividenofusp alfa
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 99 people
- Sponsor
- Denali Therapeutics Inc.
Sudden Infant Death
Do Pacifiers Protect From Sudden Infant Death Syndrome (SIDS) Through an Increase in Upper Airway Patency?
Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age in the developed world. SIDS continues to be a phenomenon of unknown cause.
- Trial name
- NCT01120938
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Ziv Hospital
Mucopolysaccharidosis II
Mucopolysaccharidosis Type II Natural History
Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, is caused by a deficiency of iduronate-2-sulfatase (IDS) leading to an accumulation of glycosaminoglycans (GAGs) in tissues of MPS II patients, resulting in…
- Trial name
- NCT03529786
- Where
- 3 sites in United States, Brazil and 1 more
- Volunteers
- 36 people
- Sponsor
- REGENXBIO Inc.
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.
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
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.
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
Health Education, Sudden Infant Death
Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
The delivery of anticipatory guidance is an essential component of pediatric practice. Given the large amount of information to be shared during each encounter and the limited time available, there is a need for an effective and…
- Trial name
- NCT01014169
- Testing
- Note taking
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
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
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)
Hunter Syndrome
A Study of GC1111 in Hunter Syndrom Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Trial name
- NCT03920540
- Testing
- GC1111, Comparator
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Green Cross Corporation
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
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
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, 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
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
Mucopolysaccharidosis I, Mucopolysaccharidosis II
Clinical Trial of Growth Hormone in MPS I, II, and VI
The purpose of this study is to determine whether growth hormone is a safe and effective treatment for short stature in children with Mucopolysaccharidosis type I, II, and VI.
- Conditions
- Mucopolysaccharidosis I, Mucopolysaccharidosis II, Mucopolysaccharidosis VI
- Trial name
- NCT00748969
- Testing
- Somatropin (DNA origin)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
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