Clinical trials: Infant Death
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
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.
Malaria
Revaccination of Young Children With Bacille Calmette Guerin (BCG) Vaccine
BCG has marked immune stimulatory effects in both animal and human studies and observational studies suggest that BCG is associated with a non-specific reduction in mortality in areas with high infant and child mortality.
- Trial name
- NCT00126217
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,871 people
- Sponsor
- Bandim Health Project
Neonatal Herpes Simplex Infection, Neonatal HSV Infection
Host RNA Expression Profiles and Protein Biomarkers in Neonatal Herpes Simplex Virus Infection
This study seeks to identify and test host RNA expression profiles in context to protein biomarkers in dried blood spot samples as novel diagnostic markers of neonatal herpes simplex virus infection and to improve the…
- Conditions
- Neonatal Herpes Simplex Infection, Neonatal HSV Infection, Neonatal Infection, Newborn; Infection
- Trial name
- NCT05226949
- Where
- 2 sites in Denmark
- Volunteers
- 159 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Mortality Through Six Months of Age, Vitamin A Deficiency
Community Trial of Newborn Vitamin A Supplementation to Reduce Infant Mortality in Rural Bangladesh
The purpose of this trial is determine whether a 50,000 IU oral dose of vitamin A delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%.
- Trial name
- NCT00128557
- Testing
- vitamin A supplementation (15,000 ug retinol equivalents or 50,000 IU)
- Where
- Bangladesh
- Volunteers
- 15,937 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Stillbirth
Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
The study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies.
- Trial name
- SPiRE (NCT03231007)
- Testing
- Questionnaire
- Where
- 20 sites in United Kingdom
- Volunteers
- 4,952 people
- Sponsor
- University of Manchester
Prenatal Care
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning.
- Trial name
- NCT02330887
- Testing
- Group Antenatal Care, Individual Antenatal Care
- Where
- Nepal
- Volunteers
- 2,184 people, healthy volunteers welcome
- Sponsor
- Possible
Fetal Distress, Stillbirth
Introducing Fetal Scalp Stimulation as an Adjunct to Intermittent Auscultation in Low-Resource Settings.
This study is a pilot study taking place in Moshi, Tanzania at the Kilimanjaro Christian Medical Centre (KCMC). The study aims to introduce fetal scalp stimulation into the intermittent auscultation protocols at KCMC, and to…
- Conditions
- Fetal Distress, Stillbirth, Birth Asphyxia, Acidosis
- Trial name
- NCT02862925
- Testing
- Fetal Scalp Stimulation
- Where
- Tanzania
- Volunteers
- 550 people
- Sponsor
- Duke University
Inherited Metabolic Diseases, Lysosomal Storage Disorders
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases
Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a possible cure for their inherited metabolic disease.
- Conditions
- Inherited Metabolic Diseases, Lysosomal Storage Disorders, Peroxisomal Storage Diseases, Inborn Errors of Metabolism
- Trial name
- UCBT-002 (NCT00654433)
- Testing
- ALD-101
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Aldagen
Tuberculosis
Should Low Birth Weight Infants Be Vaccinated With BCG Vaccine at Birth in Developing Countries?
The World Health Organization (WHO) currently recommends BCG vaccination at birth in developing countries. Pre-term infants should be vaccinated when they reach the chronological age of 40 weeks.
- Trial name
- NCT00146302
- Testing
- Bacille Calmette Guerin (BCG)
- Where
- Guinea-Bissau
- Volunteers
- 2,320 people
- Sponsor
- Bandim Health Project
Extubation Failure, Bronchopulmonary Dysplasia
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted…
- Conditions
- Extubation Failure, Bronchopulmonary Dysplasia, Death
- Trial name
- DIVA (NCT05446272)
- Testing
- NIV-NAVA, NS-NIPPV
- Where
- 20 sites in United States, Canada
- Volunteers
- 478 people
- Sponsor
- University of Pennsylvania
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.
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
Heterologous Immunity, Infant Morbidity
Comparing Morbidity and Mortality Effects of Two Different Strains of BCG
Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (TB) is associated with reduced…
- Conditions
- Heterologous Immunity, Infant Morbidity, Infant Mortality, Trained Immunity
- Trial name
- NCT03400878
- Testing
- BCG-Japan, BCG-Russia
- Where
- 2 sites in Guinea-Bissau
- Volunteers
- 17,505 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Sudden Infant Death Syndrome, Apnea
Incidence and Severity of Cardiorespiratory Events in Infants at Increased Epidemiological Risk for Sudden Infant Death Syndrome (SIDS)
OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events documented by home monitoring in infants at increased epidemiological risk for sudden infant death syndrome (SIDS). II.
- Trial name
- NCT00004392
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes
Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC
This is a data collection study that will examine the general diagnostic and treatment data associated with the reduced-intensity chemotherapy-based regimen paired with simple alemtuzumab dosing strata designed to prevented graft…
- Conditions
- Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias
- Trial name
- PRO-RIC (NCT04528355)
- Testing
- data collection
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paul Szabolcs
Sepsis, Pneumonia
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal…
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia
- Trial name
- EmONC (NCT01751945)
- Testing
- EmONC package
- Where
- Pakistan
- Volunteers
- 12,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
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 (MPS)
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of…
- Trial name
- NCT02095015
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 159 people
- Sponsor
- Shire
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