Clinical trials: Pregnancy - Labor Monitoring
Pre-Term
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants.
- Trial name
- COSMIC (NCT06526091)
- Testing
- Cerebral NIRS monitoring at delivery
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Imperial College Healthcare NHS Trust
Hemorrhage, Premature Infants
NIRS Monitoring in Premature Infants
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for…
- Conditions
- Hemorrhage, Premature Infants, Newborn, Hydrocephalus
- Trial name
- NCT02601339
- Testing
- ETV/CPC
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Infant Development, Maternal Stress
Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress…
- Conditions
- Infant Development, Maternal Stress, Growth
- Trial name
- NCT06144450
- Testing
- Web-Based Monitoring Program
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Gazi University
Preterm Infant
Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants
In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2).
- Trial name
- NCT03758313
- Testing
- CO2 measurements
- Where
- Austria
- Volunteers
- 27 people
- Sponsor
- Tobias Werther
Infant Premature, Growth and Development
NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units.
- Conditions
- Infant Premature, Growth and Development, Neurologic Disorder, Sleep Fragmentation
- Trial name
- NCT04624347
- Testing
- Access to video and movement curves
- Where
- 2 sites in France
- Volunteers
- 74 people
- Sponsor
- Rennes University Hospital
Brain Injuries, Infant, Premature
SafeBoosC - a Phase II Trial
Background 25,000 infants are born extremely preterm every year in Europe. This group of infants carries a high risk of death and subsequent cerebral impairment for the infant, especially in the first 72 hours of life.
- Trial name
- SafeBoosC (NCT01590316)
- Testing
- Cerebral NIRS oximetry
- Where
- Denmark
- Volunteers
- 165 people
- Sponsor
- Gorm Greisen
Infant, Premature, Hypoperfusion in Newborn
Monitoring of Systemic or Organ Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants.
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- Trial name
- NCT03136172
- Testing
- NIRS (near Infra-red spectroscopy)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Inha University Hospital
Preterm, Patent Ductus Arteriosus
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia
- Trial name
- CE-NeoDoppler (NCT06646250)
- Testing
- NeoDoppler - CE certified
- Where
- Norway
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- St. Olavs Hospital
Premature Birth
A Smart, "Always -On" Health Monitoring System
This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals
- Trial name
- NCT02865070
- Testing
- Skin Sensor
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Apnea of Prematurity
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.
- Trial name
- DREAM (NCT05196646)
- Testing
- Respiratory Acoustic Sensors, Nasal thermistor, Respiratory Inductive Plethysmography
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Necrotizing Enterocolitis
Monitoring Necrotizing Enterocolitis in Premature Infants
The investigators are studying a disease called "necrotizing enterocolitis" (or "NEC" for short), which affects premature infants.
- Trial name
- NCT01287559
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Spectros Corporation
Intrauterine Growth Retardation (IUGR), Lung Function Tests
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound.
- Conditions
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring
- Trial name
- ELFIGO (NCT06919757)
- Testing
- fetal ultrasound to assess lungs, heart and diaphragm
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is
Use of Decision Support in the Management of Labour
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the…
- Conditions
- Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, Possible
- Trial name
- INFANT (NCT02010710)
- Testing
- INFANT software
- Where
- 21 sites in Ireland, United Kingdom
- Volunteers
- 47,062 people
- Sponsor
- University College, London
Preterm Infant, Infant, Newborn
Neonatal Wireless Monitoring System for Intensive Care
Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors.
- Conditions
- Preterm Infant, Infant, Newborn, Low; Birthweight, Extremely (999 Grams or Less)
- Trial name
- NCT04241263
- Testing
- Wireless vital sign monitoring - comparative, Wireless vital sign monitoring - usability
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Infant, Premature
Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database
Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic.
- Trial name
- Digi-NewB (NCT02863978)
- Testing
- Multimodal signal acquisitions
- Where
- 6 sites in France
- Volunteers
- 746 people
- Sponsor
- Rennes University Hospital
Other Preterm Infants
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and…
- Trial name
- NCT02231801
- Testing
- Mother-Infant Dyad
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Acute Kidney Injury, Premature Infant
NIRS Monitoring to Detect AKI in Preterm Infants
This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely.
- Trial name
- nNIRS-AKI (NCT03384173)
- Testing
- Near Infrared Spectroscopy
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Wisconsin, Madison
Premature Birth, Extremely Low Birth Weight
DCS Study in Extremely Premature Newborns
The researchers are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA) infants, such that in the future, real-time monitoring will be possible, to aid clinicians in management of these infants.
- Conditions
- Premature Birth, Extremely Low Birth Weight, Infant, Small for Gestational Age, Intracerebral Hemorrhage
- Trial name
- NCT04367181
- Testing
- Diffuse Correlation Spectroscopy (DCS), Amplitude Integrated Electroencephalography (aEEG)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Maria Angela Franceschini
Catheters, Indwelling, Preterm Birth
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has…
- Conditions
- Catheters, Indwelling, Preterm Birth, Compromised Health
- Trial name
- IMPROVE (NCT06616012)
- Testing
- Neosense umbilical catheter
- Where
- 6 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Neosense Technologies