Clinical trials: Neonatal Deaths
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
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Accelerating Maternal and Newborn Survival: The AMANI Study
The goal of this cluster randomized controlled trial is to learn if a practice facilitation package (including both audit and feedback and enhanced mentorship) can increase the use of maternal and perinatal death surveillance and…
- Conditions
- Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality, Neonatal Mortality, Perinatal Mortality
- Trial name
- AMANI (NCT07560839)
- Testing
- Audit and Feedback, Enhanced Mentorship
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- University of Washington
Cause of Mortality, Cause of Neonatal Death
Defining Causes of Deaths in South and Southeast Asia
Brief Summary: Mortality data are important in low and middle-income countries to assess the population health status and trends.
- Conditions
- Cause of Mortality, Cause of Neonatal Death, Cause of Child Death, Cause of Maternal Death
- Trial name
- SEACTN-VA (NCT04595656)
- Testing
- verbal autopsy interview
- Where
- 5 sites in Bangladesh, Burma and 3 more
- Volunteers
- 3,413 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Neonatal Death, Perinatal Death
CHV-NEO: Community-based Digital Communication to Support Neonatal Health
Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate…
- Trial name
- NCT05187897
- Testing
- CHV-NEO
- Where
- Kenya
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
Low Birth Weight Baby, Small for Gestational Age (SGA)
Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)
The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies.
- Conditions
- Low Birth Weight Baby, Small for Gestational Age (SGA), Preterm Birth, Pregnancy Complications
- Trial name
- BIRTH (NCT06957769)
- Testing
- heat stress
- Where
- 3 sites in Pakistan
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Neonatal Death, Stillbirth
Asia Pregnancy Outcomes Study
Preterm birth is a major cause of child mortality and morbidity, most of which occurs in south-east Asia and sub-Saharan Africa.
- Trial name
- NCT03438110
- Where
- 3 sites in India, Pakistan
- Volunteers
- 1,226 people, healthy volunteers welcome
- Sponsor
- RTI International
Preeclampsia, Intrauterine Growth Restriction
sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term.
Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world.
- Conditions
- Preeclampsia, Intrauterine Growth Restriction, Maternal Hypertension, Neonatal Outcome
- Trial name
- PE37 (NCT04766866)
- Testing
- sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation
- Where
- 21 sites in Belgium, Colombia and 7 more
- Volunteers
- 9,132 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Neonatal Death, Birth Asphyxia
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person.
- Trial name
- NCT05854745
- Testing
- HBB Virtual Training, HBB In-person Training
- Where
- Ethiopia
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Stanford University
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Neonatal Death, Perinatal Death
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
To improve neonatal mortality, it is critical to engage families, especially mothers, in essential newborn care (ENC) and appropriate care-seeking for neonatal illness as well as to support maternal mental health and…
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Trial name
- NCT04598165
- Testing
- Interactive two-way SMS dialogue
- Where
- 6 sites in Kenya
- Volunteers
- 5,020 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Maternal Death, Maternal Morbidity
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in…
- Conditions
- Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death
- Trial name
- BetterBirth (NCT02148952)
- Testing
- WHO Safe Childbirth Checklist Program
- Where
- India
- Volunteers
- 157,689 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Death; Neonatal, Death, Infant
Trial to Compare BCG-Bulgaria and BCG-Denmark
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines…
- Conditions
- Death; Neonatal, Death, Infant, Morbidity;Newborn, Morbidity;Infant
- Trial name
- BCGSTRAIN IV (NCT05397678)
- Testing
- BCG-Denmark, BCG-Bulgaria
- Where
- Guinea-Bissau
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Neonatal Death, Perinatal Death
Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya
Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in…
- Conditions
- Neonatal Death, Perinatal Death, Depression
- Trial name
- AI-NEO (NCT05369806)
- Testing
- Interactive two-way SMS dialogue
- Where
- 2 sites in Kenya
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Washington
Neonatal Death, Preterm Birth
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020.
- Conditions
- Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
- Trial name
- NCT02605369
- Testing
- Intervention arm: An integrated package
- Where
- Uganda
- Volunteers
- 1,877 people, healthy volunteers welcome
- Sponsor
- Makerere University
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Preterm Birth, Preterm Labor
Impact of the PREEMI Package on Neonatal Mortality
The purpose of this Quality Improvement initiative is to reduce severe morbidity and mortality among premature infants through proven and cost-effective clinical management during the antenatal, intrapartum, and postpartum…
- Conditions
- Preterm Birth, Preterm Labor, Neonatal Death
- Trial name
- PREEMI (NCT03923023)
- Where
- 2 sites in Zambia
- Volunteers
- 11,195 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Neonatal Death, Prematurity
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
BACKGROUND An essential part of neonatal care is providing nutrition to ensure that babies grow and develop. Providing this can be difficult in premature babies because their intestines are underdeveloped.
- Trial name
- NCT03767634
- Testing
- Parenteral nutrition
- Where
- United Kingdom
- Volunteers
- 97,507 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Perinatal Death, Respiratory Distress Syndrome, Newborn
Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities
Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice.
- Conditions
- Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure
- Trial name
- NCT03996317
- Testing
- Room air
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Loma Linda University
External Causes of Morbidity and Mortality, Stillbirth
Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan
Pakistan is one of the countries in South Asia where neonatal mortality rates remain stagnant. Babies born in Pakistan encounter the highest risk of dying; of every 1,000 babies born, 46 die before the end of their first month…
- Conditions
- External Causes of Morbidity and Mortality, Stillbirth, Neonatal Death
- Trial name
- NCT03904706
- Testing
- Audits only, Audits with community feedback
- Where
- Pakistan
- Volunteers
- 1,871 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Perinatal Death, Neonatal Death
Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
The purpose of this study is to conduct Verbal Autopsies of deaths ( stillbirths and neonatal deaths together) identified in the BetterBirth trial to identify their potential causes, timing, and social determinants.
- Conditions
- Perinatal Death, Neonatal Death, Stillbirth
- Trial name
- NCT03213509
- Testing
- Interview (Social and Verbal Autopsy)
- Where
- India
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)