Clinical trials: NICU
Neonatal Neuroimaging
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- NCT02785588
- Testing
- 3.0 T Neonatal MRI scanner
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Growth, Neonates
Improving Artificial Intelligence-derived Algorithms for Estimating Length and Weight in NEonateS and infanTs up to 6 Months of Age (NEST)
The NEST study is a prospective, observational research study designed to collect clinical measurements and image data to develop and evaluate artificial intelligence (AI)-derived algorithms for estimating anthropometric…
- Conditions
- Growth, Neonates, AI (Artificial Intelligence)
- Trial name
- NEST (NCT07514182)
- Where
- Singapore
- Volunteers
- 60 people
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Breastfeeding
Pilot Study of the FEEDBACK System for Use With Infants in the Neonatal Intensive Care Unit at University of Virginia
The purpose of this study is to assess the accuracy of FEEDBACK for measuring breastmilk intake of a pre-term baby. Mothers and babies will use the FEEDBACK system during a breastfeeding session in the NICU.
- Trial name
- NCT03702686
- Testing
- FEEDBACK System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Molex Ventures LLC
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
Diaper Dermatitis
BM Collection From NICU Infants for Composition
The primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition.
- Trial name
- NCT02570698
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Kimberly-Clark Corporation
Respiratory Distress Syndrome, Newborn
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
- Trial name
- NCT01102543
- Where
- France
- Volunteers
- 972 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Neonates
NICU-TECH RM9L-RS Probe ME Feasibility Study
Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself.
- Trial name
- NCT01181596
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- GE Healthcare
Respiratory Insufficiency in Children
Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO…
- Trial name
- NCT04957472
- Testing
- fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function, Manual Control
- Where
- 5 sites in Netherlands, Poland
- Volunteers
- 47 people
- Sponsor
- Vyaire Medical
Establish Normative pH Values in Neonates
Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
Objectives: 1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor 2.
- Trial name
- NCT02279264
- Testing
- RightSpot Infant pH Indicator
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- RightBio Metrics
Preterm Infant
The FOUNDATION Study
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint.
- Trial name
- FOUNDATION (NCT03939546)
- Testing
- B. infantis EVC001
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Evolve BioSystems, Inc.
Intestinal Failure
AI-driven Total Parenteral Nutrition Platform
This study tests whether an artificial intelligence (AI) tool can help doctors order total parenteral nutrition (TPN) for babies in the neonatal intensive care unit (NICU).
- Trial name
- NCT07414576
- Testing
- AI-driven total parenteral nutrition (TPN)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Takeoff41, Inc.
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
Neonatal Neurological Observation With Video AI
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside…
- Conditions
- Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
- Trial name
- NeoNOVA (NCT07628829)
- Testing
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Artemis AI Labs
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Image Evaluation
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- Firefly (NCT02232009)
- Testing
- 3.0 T Neonatal MRI Scanner
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- GE Healthcare
Preterm Infant Health, Premature Babies
Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants.
- Trial name
- NEOMOM (NCT07576972)
- Testing
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Mother's Milk is Best
Premature Birth
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.
- Trial name
- NCT06063122
- Testing
- smallTalk NICU Active
- Where
- 2 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Thrive Neuromedical, LLC
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
Neonatal Intensive Care
Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique
Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.
- Trial name
- CH (NCT01610622)
- Testing
- COstatus cardiac output measurement with isotonic saline
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Transonic Systems Inc.
Hypoxemia
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
- Trial name
- NCT01085539
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG