Clinical trials: Neonates or Premature Babies
Preterm Infant, Low Birth Weight Infant
m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care…
- Conditions
- Preterm Infant, Low Birth Weight Infant, Kangaroo Mother Care, Hypothermia, Newborn
- Trial name
- NCT04929977
- Testing
- Wearable device with smart mobile phone
- Where
- India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- St. John's Research Institute
Respiratory Distress, Transient Tachypnea of the Newborn
Effect of Supine or Prone Position After Caesarean Birth
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs.
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Trial name
- NCT01310153
- Testing
- prone positioning, Supine
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Neonatal Disease, Intubation; Difficult or Failed
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
- Trial name
- NCT06263790
- Testing
- Intubating laryngeal mask, Direct laryngoscopy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Neuroimaging
Evaluation of the Implementation of the Hemispheric Dominance During Development
Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the…
- Trial name
- HEMISPHERENOR (NCT02826733)
- Testing
- Electroencephalogram (EEG), Near Infra Red Spectroscopy (NIRS), magnetic resonance imaging (MRI)
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Amniotic Fluid & the Preterm Gut
Background: Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations.
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset
- Trial name
- AMFIBIE (NCT07152106)
- Where
- 2 sites in Netherlands
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Hypothermia, Newborn, Preterm Birth Complication
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death.
- Conditions
- Hypothermia, Newborn, Preterm Birth Complication, Neonatal Hypothermia
- Trial name
- UP (NCT04761484)
- Testing
- Vascular access on admission
- Where
- Ireland
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Preg Complications: Hemorrhagic, Infant, Premature, Diseases
Maternal & Infant Morbidity and Mortality
The purpose of this project is to evaluate maternal and infant outcomes based on race at UVA hospital. Health inequities are influenced by a combination of Social, Political, and Clinical determinants of health.
- Conditions
- Preg Complications: Hemorrhagic, Infant, Premature, Diseases, Preg Complications: Hemorrhagic Intervillous of Placenta, Preg Complications: Bleeding From Female Genital Tract
- Trial name
- NCT06145568
- Testing
- Pregnant Women
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Bronchopulmonary Dysplasia, Death
Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial
The investigators aimed to compare the effectiveness of nasal mask and prongs used in CPAP (nasal continuous positive airway pressure)as the initial respiratory support when using minimal ly invasive surfactant therapy (MIST) in…
- Trial name
- MASK (NCT02287116)
- Testing
- Easy Flow system and INCA® nasal cannulae set
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Retinopathy of Prematurity, ROP
Validation of i-ROP DL to Detect More Than Mild ROP
The purpose of the pivotal reader study is to assess the readers' accuracy in diagnosing plus disease versus no plus or pre-plus disease with or without the aid of the i-ROP DL.
- Trial name
- NCT06109285
- Testing
- iROP DL
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Siloam Vision
Transient Tachypnea of the Newborn, TTN
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.
- Conditions
- Transient Tachypnea of the Newborn, TTN, Respiratory Distress Syndrome, RDS
- Trial name
- NCT01517958
- Testing
- Respiratory Distress Group, Control Group
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Sepsis, Neonatal
Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies
The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams) The main questions it aims to answer are: What is…
- Trial name
- NCT06414174
- Testing
- Split septum needleless connector, Mechanical valve needleless connector
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Neonates and Preterm Infants, Neonates or Premature Babies
Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking.
- Trial name
- CONEXUS (NCT06940713)
- Testing
- Imaging Time
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
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
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Suspected Damage to Fetus From Other Disease in the Mother, Affecting Management of Mother, With Delivery, Patient Death or Serious Disability Associated With A Haemolytic Reaction Due to the Administration of ABO-Incompatible Blood or Blood Products
The Use of Lung Ultrasonography in the Delivery Room in Neonates
Lung ultrasonography has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method.
- Trial name
- LUSIN (NCT06314789)
- Testing
- doing lung ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Kırıkkale University
Temperature Regulation; Disorder, Fetus or Newborn
Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth.
- Trial name
- NEODRY (NCT05740072)
- Testing
- Drying before wrapping, No drying before wrapping
- Where
- Italy
- Volunteers
- 346 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Diastolic Dysfunction, Neonatal Encephalopathy
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined…
- Conditions
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn
- Trial name
- DiFuSE (NCT06200519)
- Where
- Ireland
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- University College Cork
Respiratory Distress, Newborn
Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress
Neonatal respiratory distress is a common problem in preterm infants. The application of CPAP is widely used in neonatal units as a primary mode of respiratory support for respiratory distress.
- Trial name
- NCT06436222
- Testing
- HVNI
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia