Clinical trials: Death, Infant
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Infant Morbidity, Infant Mortality
BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa
Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections.
- Conditions
- Infant Morbidity, Infant Mortality, Non-Specific Effects of Vaccines, BCG
- Trial name
- BCG2-DTP3 (NCT07005726)
- Testing
- BCG Vaccine
- Where
- Guinea-Bissau
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Kangaroo Mother Care, Preterm Infant
Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa
We will conduct an individually randomised, controlled, superiority trial with two parallel groups; an intervention arm allocated to receive KMC and a control arm receiving 'standard' care.
- Conditions
- Kangaroo Mother Care, Preterm Infant, Death; Neonatal, Hypothermia, Newborn
- Trial name
- OMWaNA (NCT02811432)
- Testing
- Kangaroo mother care, Standard care
- Where
- 4 sites in Uganda
- Volunteers
- 2,221 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Omphalitis, Infection
Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution
- Trial name
- CHX (NCT00434408)
- Testing
- chx once, CHX x 7 days, dry cord care
- Where
- Bangladesh
- Volunteers
- 28,797 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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 Syndrome
The Effect of the Use of Mobile App
This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death…
- Trial name
- NCT07032402
- Testing
- Education and Counseling, Standard Care
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Amasya University
Bronchopulmonary Dysplasia, Death
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Trial name
- NCT06082414
- Testing
- no interventions
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Peking University
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
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.
Vitamin A Deficiency, Maternal Mortality
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh
The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three…
- Conditions
- Vitamin A Deficiency, Maternal Mortality, Infant Mortality
- Trial name
- NCT00198822
- Testing
- Vitamin A or Beta-Carotene Supplements
- Where
- 3 sites in United States, Bangladesh
- Volunteers
- 59,666 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
Death, Nosocomial Infection
Prophylactic Probiotics in Premature Infants
This study tries to determine whether the oral administration of a specific probiotic (good bacteria) in premature infants hospitalized in a neonatal intensive care unit may prevent infections and the development of a severe…
- Trial name
- C3P (NCT00727363)
- Testing
- Lactobacillus reuteri
- Where
- 8 sites in Colombia
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Colombian Neonatal Research Network
Sudden Infant Death
Infant Care Practices Study
This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of…
- Trial name
- ICP (NCT03494621)
- Testing
- Protecting Babies While they Sleep Curriculum
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Avera McKennan Hospital & University Health Center
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
Premature Birth, Perinatal Mortality
Assessing the Impact of Smoke-free Legislation on Perinatal Health in the Netherlands
The purpose of this study is to investigate whether there has been a change in perinatal outcomes following the phased smoking ban introduction (January 2004 for workplaces; July 2008 for bars and restaurants) workplaces in the…
- Conditions
- Premature Birth, Perinatal Mortality, Infant, Low Birth Weight, Stillbirth
- Trial name
- NCT02189265
- Testing
- Smoke-free legislation
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 2,069,695 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
African American Infant Sleep Beliefs and Practices
Improving the Self-Efficacy of African American Parents in Infant Supine Sleep
This is a research study of African American parents/caregivers of newborns. The purpose of this research study is to learn what type of educational materials about infant safety and safe infant sleep are most effective and…
- Trial name
- PrAAIS (NCT01707173)
- Testing
- Tailored education, Standard Education
- Where
- United States
- Volunteers
- 735 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Pneumonia, Diarrhea
Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease
Title: Impact of daily zinc supplementation to infants born with low birth weight on mortality and severe disease requiring hospitalization Background: Zinc supplementation was shown to prevent diarrhea and pneumonia in 6 month…
- Conditions
- Pneumonia, Diarrhea, Meningitis, Sepsis
- Trial name
- NCT00495690
- Testing
- Oral zinc gluconate (5 mg elemental)
- Where
- India
- Volunteers
- 2,012 people
- Sponsor
- Society for Applied Studies
Pregnancy Complications, Preterm Birth
Group Antenatal/Postnatal Care in Rwanda
The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge, and Rubavu).
- Conditions
- Pregnancy Complications, Preterm Birth, Preterm Labor, Stillbirth
- Trial name
- PTBi Rwanda (NCT03154177)
- Testing
- Group ANC/PNC, Ultrasound+Pregnancy Testing
- Where
- 2 sites in Rwanda
- Volunteers
- 26,381 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Mucopolysaccharidosis II
Mucopolysaccharidosis Type II Observational
This is an observational study planned to document prospectively disease manifestation and neurocognitive course in pediatric patients with a clinical presentation consistent with neuronopathic ("severe") MPS II undergoing…
- Trial name
- NCT04591834
- Testing
- Observational
- Where
- 3 sites in United States, Canada
- Sponsor
- REGENXBIO Inc.
Pregnancy Related, Delivery of Health Care
Evaluating the Saving Babies Lives Care Bundle Version 2
The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality.
- Trial name
- eVOLVE (NCT06453954)
- Where
- United Kingdom
- Volunteers
- 1,773 people
- Sponsor
- University of Manchester