Clinical trials: Neonatal and Perinatal Conditions
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
covid19 Infection, Pregnancy Complications
Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns
The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context
- Conditions
- covid19 Infection, Pregnancy Complications, Neonatal Complications
- Trial name
- Coropreg (NCT04463758)
- Testing
- An auto-questionnaire comprising three psychometric scales
- Where
- France
- Volunteers
- 6,015 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Encephalopathy, Hypoxic-Ischemic, Infant, Newborn, Diseases
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per…
- Trial name
- ALBINO (NCT03162653)
- Testing
- Allopurinol, Mannitol
- Where
- 12 sites in Austria, Belgium and 10 more
- Volunteers
- 760 people
- Sponsor
- University Hospital Tuebingen
Seizures, Encephalopathy
Novel Epidermal Recording and Detection of Seizures
For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity.
- Conditions
- Seizures, Encephalopathy, Asphyxiated Newborn
- Trial name
- NERDS (NCT02451618)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Sharp HealthCare
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
Neonatal Death, Infectious Disease
Vitality in Infants Via Azithromycin for Neonates Trial
Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal…
- Conditions
- Neonatal Death, Infectious Disease, Nutritional Deficiency
- Trial name
- VIVANT (NCT05763693)
- Testing
- Azithromycin at Baseline, Azithromycin at Day 21
- Where
- Burkina Faso
- Volunteers
- 4,000 people
- Sponsor
- University of California, San Francisco
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
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
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
Hypoxic-Ischemic Encephalopathy
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
- Trial name
- CerebroHIE (NCT01059461)
- Testing
- Cerebrolysin®
- Where
- 2 sites in Egypt
- Volunteers
- 40 people
- Sponsor
- Sahar M.A. Hassanein, MD
Stillbirths, Sudden Infant Death
Magnetic Resonance Imaging Autopsy Study
The aim of this project is to establish whether magnetic resonance (MR) imaging can provide a minimally invasive approach for post-mortem assessment of the fetus, infant and child, with similar detection rates for anomalies and…
- Trial name
- MARIAS (NCT01417962)
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Thayyil, Sudhin
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Stroke With Hemiparesis, Perinatal Stroke
National Egyptian Network Pediatric Stroke and Hemiplegia Registry
Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.
- Conditions
- Stroke With Hemiparesis, Perinatal Stroke, Focal Neurologic Deficits
- Trial name
- NCT02129491
- Where
- Egypt
- Volunteers
- 1,000 people
- Sponsor
- Ain Shams University
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
Pregnancy, Birth Weight
Prenatal Multi-micronutrient Supplementation and Pregnancy Outcome
Prenatal maternal micronutrient supplementation has been suggested as a means to reduce the proportion of low birth weight babies in low-income countries.
- Trial name
- NCT00168688
- Testing
- multi micronutrient supplement, MN1, MN2
- Where
- Guinea-Bissau
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Bandim Health Project
Acute Kidney Injury
Acute Kidney Injury in Newborns With Perinatal Asphyxia
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to…
- Trial name
- NCT03617055
- Testing
- serum cystatin c
- Volunteers
- 50 people
- Sponsor
- Assiut University
Sepsis, Umbilical Cord
Perinatal Handwashing Intervention in Bangladesh
The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.
- Conditions
- Sepsis, Umbilical Cord, Infection
- Trial name
- NCT01309321
- Testing
- Perinatal Handwashing Promotion, Neonatal Health Promotion
- Where
- Bangladesh
- Volunteers
- 400 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Maternal Death, Neonatal Death
Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana
Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5.
- Conditions
- Maternal Death, Neonatal Death, Postpartum Haemorrhage, Pre-eclampsia
- Trial name
- Accelerate (NCT02468310)
- Testing
- Maternal and neonatal emergency protocols
- Where
- Ghana
- Volunteers
- 65,831 people, healthy volunteers welcome
- Sponsor
- Hannah Brown Amoakoh
Safety Issues, Effect of Drugs
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Trial name
- NCT03760900
- Testing
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Volunteers
- 15 people
- Sponsor
- Guangdong Women and Children Hospital