Clinical trials: Neonatal
Epilepsy, Benign Neonatal
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure.
- Trial name
- NCT04320940
- Testing
- Phenobarbital Sodium Injection
- Where
- 8 sites in United States, Jordan
- Volunteers
- 4 people
- Sponsor
- NEMA Research, Inc.
Feeding Patterns, Feeding; Difficult, Newborn
Neoneur Feeding System Functionality in the Clinic
Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial
- Conditions
- Feeding Patterns, Feeding; Difficult, Newborn, Feeding Disorder Neonatal
- Trial name
- NN200 (NCT05525091)
- Testing
- Feeding Evaluation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neoneur LLC
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Neonatal Jaundice
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
- Trial name
- allphones (NCT05955144)
- Testing
- Picterus JP
- Where
- Norway
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia.
- Trial name
- NCT05630495
- Testing
- Picterus Jaundice Pro
- Where
- 2 sites in Indonesia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
- Trial name
- NCT05650463
- Testing
- Picterus Jaundice Pro
- Where
- Sweden
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Hypoxia Neonatal
Owlet Smart Sock 3 Accuracy on Infants
The purpose of this research study is to evaluate the Owlet Smart Sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a…
- Trial name
- NCT05635513
- Testing
- Owlet OSS V3
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Owlet Baby Care, Inc.
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Neonatal Disorder
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper.
- Trial name
- CTOM-FIH (NCT03706976)
- Testing
- Tissue Oxygenation Monitoring
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Carag AG
Jaundice, Neonatal
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to…
- Trial name
- NCT05616845
- Testing
- Picterus Jaundice Pro
- Where
- Philippines
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.
- Trial name
- NCT05625880
- Testing
- Picterus Jaundice Pro
- Where
- Nepal
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Jaundice, Neonatal
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
- Trial name
- NCT05623553
- Testing
- Picterus Jaundice Pro
- Where
- Mexico
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Newborn Jaundice
BiliCam Clinical Validation Study
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in…
- Trial name
- NCT03246503
- Testing
- BiliCam estimated bilirubin (BCB)
- Where
- United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BiliCam, LLC
Neonatal Sepsis
Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis
This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group. The aim of the study was to evaluate the hypothesis that an immunonutritional strategy, based on use of…
- Trial name
- NCT04742582
- Testing
- Preterm Infants - fed fermented formula, Preterm Infants - fed standard formula, Pre-term Infants - breastfed
- Where
- Italy
- Volunteers
- 876 people
- Sponsor
- Heinz Italia SpA
Newborn Jaundice
Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia.
- Trial name
- Bili-PrediX1 (NCT05121311)
- Testing
- NeoprediX B1 algorithm
- Where
- 2 sites in Germany
- Volunteers
- 455 people
- Sponsor
- NeoPredix AG
Neonatal Respiratory Distress Syndrome
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome)…
- Trial name
- NCT03235986
- Testing
- nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I), nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II), nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)
- Where
- Italy
- Volunteers
- 166 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Cerebrotendinous Xanthomatosis
The Prevalence of CTX Disorder in Juvenile Cataract Cases in Turkey
Epidemiologic observational study. Study will include two phases: 1. Retrospective cross-sectional phase: At this stage of the study, retrospective screenings are carried out at study sites and all juvenile cataract cases are…
- Trial name
- GEN-EYE-I (NCT03584893)
- Testing
- Blood sampling for Cholestanol Analysis
- Where
- 36 sites in Turkey (Türkiye)
- Volunteers
- 1,000 people
- Sponsor
- TRPHARM
Hyperbilirubinemia, Neonatal
Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat…
- Trial name
- JASMINE_205 (NCT02000830)
- Testing
- Stannsoporfin
- Volunteers
- 68 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Renal Failure, Cardiovascular Diseases
HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life Assessed by MRI Scanning
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques.
- Conditions
- Renal Failure, Cardiovascular Diseases, Congenital Disorders
- Trial name
- HD-REMODEL (NCT03280901)
- Testing
- HD, Magnetic Resonance Imaging (MRI) scans
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH