Clinical trials: Neonatal and Perinatal Conditions
Perinatal Mortality, Neonatal Morbidities
Machine Learning From Fetal Flow Waveforms to Predict Adverse Perinatal Outcomes
The aim of this study is to get a proof of concept for using a computational model of fetal haemodynamics, combined with machine learning based on Doppler patterns of the fetal cardiovascular, cerebral and placental flows, to…
- Trial name
- NCT03398551
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Respiratory Distress Syndrome (Neonatal), Intubation Complication
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated…
- Conditions
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- Trial name
- Aero-05 (NCT05960929)
- Testing
- Infasurf Aero™
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- ONY
Perinatal Asphyxia
Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care
The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.
- Trial name
- OptiNeoCare (NCT06322732)
- Where
- France
- Volunteers
- 336 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Perinatal Mortality, Premature Rupture of Fetal Membranes
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation.
- Trial name
- PPROM (NCT03108404)
- Testing
- Validation of a diagnostic test
- Where
- France
- Volunteers
- 34 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Sepsis, Necrotizing Enterocolitis
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset.
- Conditions
- Sepsis, Necrotizing Enterocolitis, Chorioamnionitis, Feeding Intolerance
- Trial name
- NEOINFLAM (NCT03320785)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Per Torp Sangild
Respiratory Distress Syndrome, Neonatal Death
Implementing LISA Surfactant in Nigeria
Implement surfactant (BLES®) replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born…
- Trial name
- NCT05714865
- Testing
- Surfactant
- Where
- 6 sites in Nigeria
- Volunteers
- 349 people
- Sponsor
- Indiana University
Neonate, Asphyxia
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying…
- Conditions
- Neonate, Asphyxia, EEG, Eye Tracking
- Trial name
- Neurobiom (NCT07702500)
- Testing
- EEG
- Where
- France
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to…
- Trial name
- NCT06090968
- Testing
- Umbilical cord milking, Immediate cord clamping
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Lady Hardinge Medical College
Hypoxic-Ischemic Encephalopathy, Cell Damage
Use of Melatonin for Neuroprotection in Asphyxiated Newborns
Protection of brain development is a major aim in the Neonatal Intensive Care Unit. Hypoxic-Ischemic Encephalopathy (HIE) occurs in 3-5 per 1000 births. Only 47% of neonates have normal outcomes.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Cell Damage, Asphyxia Perinatal
- Trial name
- MELPRO (NCT03806816)
- Testing
- Melatonin
- Where
- 6 sites in Holy See, Italy
- Volunteers
- 100 people
- Sponsor
- University Hospital of Ferrara
Obstetric and Perinatal Complications, Postpartum Hemorrhage
A Skills and Drills Intervention for Emergency Obstetrics and Neonatal Care at First Referral Units of North Karnataka
To evaluate the effectiveness of a First Referral Unit (FRU) Emergency Obstetric and Newborn Care (EmONC) skills and drills intervention, to estimate the appropriateness and effectiveness of referrals in intervention arm compared…
- Conditions
- Obstetric and Perinatal Complications, Postpartum Hemorrhage, Preeclampsia/Eclampsia, Obstructed/Prolonged Labor
- Trial name
- NCT01865656
- Testing
- Skills training, Emergency obstetric drills, Revised Case Sheets
- Volunteers
- 15,018 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Perinatal Mortality
Global Network Implementation of Helping Babies Breathe (HBB)
The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth attendants at health facilities in the Helping…
- Trial name
- NCT01681017
- Testing
- HBB/ENC Training and Equipment, HBB/ENC supplies
- Where
- 3 sites in India, Kenya
- Volunteers
- 70,704 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Perinatal Mortality, Cause of Neonatal Death
Verbal Autopsy to Assess Early Neonatal Death and Stillbirth
The NICHD Global Network (GN) for Women's and Children's Health Research, a multi-site, international research network, provides a unique infrastructure to implement an expanded perinatal verbal autopsy study using the FIRST…
- Conditions
- Perinatal Mortality, Cause of Neonatal Death, Cause of Stilbirth
- Trial name
- VA (NCT00640055)
- Testing
- Coordinator, Physician-assigned cause of death
- Where
- 4 sites in Guatemala, Pakistan and 2 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
The purpose of this study is to improve the ability of the investigators to monitor brain health in newborn babies at risk of brain injuries.
- Trial name
- NCT02793999
- Testing
- Near-Infrared Spectroscopy (NIRS)
- Where
- 3 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Children's Hospital
Maternal Death, Newborn Death
Impact of the Safe Childbirth Checklist in Luapula Province of Zambia Province of Zambia
This study would like to determine if the introduction of the Safe Childbirth Checklist and associated mentorship can improve the adherence of skilled birth attendants (SBAs) to the essential practices of childbirth delivery.
- Trial name
- NCT03263182
- Testing
- Introduction of the Safe Childbirth Checklist
- Where
- 4 sites in Zambia
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Clinton Health Access Initiative Inc.
Perinatal Stroke
Baby Brain Recovery Study
This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with…
- Trial name
- NCT05013736
- Testing
- Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Wisconsin, Madison
Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn
Feasibility and Safety of Intranasally Administered Breast Milk in HIE
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy
- Trial name
- F-NEO-BRIGHT (NCT06747260)
- Testing
- Intranasal breast milk
- Where
- Hungary
- Volunteers
- 10 people
- Sponsor
- Semmelweis University
Neonatal Death
NEO-study, Newborn Emergency Outcome
Globally, 2.9 million newborn infants die within the first 28 day of life and 2.6 million babies are born dead, 1.3 million of these being alive at the onset of labor.
- Trial name
- NEO (NCT04093778)
- Testing
- Low dose high frequency training and Safe Delivery Phone Application
- Volunteers
- 3,000 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Stillbirth, Neonatal Death
Accelerating Newborn Survival in Ghana Through a Low-dose, High-frequency Health Worker Training Approach
This study assesses the effect of a low-dose, high-frequency training approach on long-term evidence-based skill retention among skilled birth attendants and impact on adverse birth outcomes at hospitals in Ghana.
- Trial name
- NCT03290924
- Testing
- Low dose high frequency health worker training approach, Active Comparison
- Volunteers
- 40 people
- Sponsor
- Jhpiego