Clinical trials: Death, Infant
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.
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
Mucopolysaccharidosis II
A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)
This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant…
- Trial name
- COMPASS (NCT05371613)
- Testing
- tividenofusp alfa, idursulfase
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 65 people
- Sponsor
- Denali Therapeutics Inc.
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
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
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.
Stillbirths and Infant Mortality
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali
The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in…
- Trial name
- SANTE (NCT03909737)
- Testing
- Azithromycin to pregnant women, Azithromycin to infants, No intervention to pregnant women
- Where
- Mali
- Volunteers
- 99,700 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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
Grief, Post Traumatic Stress Disorder
Walk With Me (WWM) for Perinatal Grief
The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss.
- Conditions
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage
- Trial name
- PeriGrief-II (NCT07011940)
- Testing
- Along With Me, Peer Guide
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Preterm, Infant Death
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks…
- Trial name
- CORDMILK-PT (NCT06240715)
- Testing
- Umbilical cord milking
- Where
- 9 sites in India
- Volunteers
- 800 people
- Sponsor
- Nemours Children's Clinic
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
Stillbirth and Neonatal Mortality, Perinatal Mortality
Perinatal Mortality Outcomes Through Household Infection Pathways
The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh.
- Conditions
- Stillbirth and Neonatal Mortality, Perinatal Mortality, Infant Mortality, Child Mortality
- Trial name
- POTH (NCT07620613)
- Testing
- Concrete household floor
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Stanford University
Sudden Infant Death, Sudden Unexplained Infant Death
Identification of Genetic Variants Associated With Unexpected Infant Death Syndrome
This is a multicenter genetic study aimed at identifying new genes/variants associated with sudden infant death syndrome (SIDS) based on whole-genome sequencing of family trios
- Trial name
- BIOMINRISK (NCT06244433)
- Testing
- whole genome sequencing
- Where
- 18 sites in France
- Volunteers
- 650 people
- Sponsor
- Nantes University Hospital
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 Mortality, BCG
Can Earlier BCG Vaccination Reduce Early Infant Mortality? A Randomised Trial
The purpose of this study is to determine whether BCG vaccination shortly after birth can reduce early infant mortality in a rural and an urban setting.
- Trial name
- BCGR (NCT02504203)
- Testing
- BCG-Denmark 1331 (Statens Serum Institute)
- Where
- Guinea-Bissau
- Volunteers
- 2,332 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
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 Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
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
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Extremely Premature Infant, Anemia Neonatal
Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red…
- Conditions
- Extremely Premature Infant, Anemia Neonatal, Blood Transfusion, Umbilical Cord Blood
- Trial name
- NCT07502781
- Testing
- Cord Blood Red Blood Cells, Standard Adult Donor Red Blood Cells
- Where
- Spain
- Volunteers
- 176 people
- Sponsor
- Hospital Clinic of Barcelona