Clinical trials: Infant Death
Sudden Infant Death
Training About Sudden Infant Death Syndrome
Sudden infant death syndrome, which constitutes a significant proportion of all infant deaths, is associated with various preventable risk factors.
- Trial name
- SIDS (NCT06922682)
- Testing
- Training with Sudden Infant Death Syndrome Training Booklet
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ondokuz Mayıs University
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
Sudden Infant Death
Incorporation of Safe Sleep Education Into m-Health Technology
Sudden Unexplained Infant Death (SUID) is the leading cause of death in infants age 28 days to 1 year. Protective factors, such as supine positioning, firm sleep surface, breastfeeding, pacifier use, elimination of soft objects…
- Trial name
- NCT06074211
- Testing
- Safety in Seconds mobile app: Safe Sleep Education, Safety in Seconds mobile app: Car Seat Safety Education
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Infant Death, Serious Injury
The Happiest Baby, Inc. SNOO Postmarket Surveillance Study
This postmarket surveillance study will evaluate the safety of the SNOO Smart Sleeper Bassinet when used for infants who are at high risk for Sudden Unexpected Infant Death (SUID).
- Trial name
- NCT06361303
- Testing
- SNOO Bassinet
- Where
- United States
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- Happiest Baby, Inc.
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.
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
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
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
- 29 sites in United States, Argentina and 11 more
- Volunteers
- 99 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 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