Clinical trials: Premature Neonates
Preterm Birth, Low Birthweight Neonate
Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial
The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact…
- Conditions
- Preterm Birth, Low Birthweight Neonate, Periodontitis, Gingivitis
- Trial name
- XaPPP (NCT07424846)
- Testing
- Xylitol Chewing gum, Sorbitol chewing gum
- Where
- Malawi
- Volunteers
- 6,000 people
- Sponsor
- University of Washington
White Matter Injury, Brain Injury, Fetus and Neonate
Neonatal White Matter Injury Trial (WRAP)
The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental.
- Conditions
- White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia
- Trial name
- WRAP (NCT07688746)
- Testing
- Clemastine fumarate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Bridget LaMonica Ostrem, M.D., Ph.D.
Respiratory Failure, Premature Neonates
Supraglottic Airway for Resuscitation in Preemies
The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature…
- Conditions
- Respiratory Failure, Premature Neonates, Delivery Room Resuscitation, Positive Pressure Ventilation
- Trial name
- SUPREEMIE (NCT07419438)
- Testing
- Supraglottic Airway
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Pennsylvania
Prematurity, Infections, NIRS
The Peripheral(-Muscle) Oxygenation and Perfusion Score as a New Non-invasive Tool to Predict Elevations in C-reactive Protein Levels in Neonates
This is a prospective, single-center Phase II observational study investigating the predictive value of the "Peripheral(-muscle) Oxygenation and Perfusion Score" (POP-Score), a novel non-invasive composite index, for early…
- Conditions
- Prematurity, Infections, NIRS, Near Infrared Spectroscopy, Preterm Neonates
- Trial name
- POP-Score (NCT07109856)
- Testing
- POP-Score Assessment, Near-Infrared Spectroscopy (NIRS)
- Where
- Austria
- Volunteers
- 93 people
- Sponsor
- Medical University of Graz
PreTerm Neonate, Positive End Expiratory Pressure (PEEP)
PEEP FOR LUNG RECRUITMENT IN PRETERM INFANTS-EIT STUDY
Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed.
- Conditions
- PreTerm Neonate, Positive End Expiratory Pressure (PEEP), Lung Recruitment, Electrical Impedance Tomography (EIT)
- Trial name
- [PEOPLE] (NCT06705257)
- Testing
- Studying the effects of varying levels of PEEP using Electrical impedance tomography
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- South Tees Hospitals NHS Foundation Trust
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
Neonates or Premature Babies, Parent
Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit
This is a pre/post quasi-interventional study with two arms. First, a baseline cohort of parent-infant dyads admitted to the Neonatal Intensive Care Unit (NICU) were enrolled and surveyed at three timepoints (admission…
- Conditions
- Neonates or Premature Babies, Parent, Reading, NICU Infants
- Trial name
- NCT07511075
- Testing
- Shared reading program
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Catherine Caruso
Sodium Supplementation and Growth in Premature Neonates
Sodium Supplementation and Growth in Premature Neonates
Primary aim: to assess the impact of late (≥7 days postnatal) sodium supplementation of premature neonates with birth weight less than 2500 gm on their postnatal short-term catch-up growth.
- Trial name
- NCT07350135
- Testing
- Sodium supplementation guided by serum sodium and fraction sodium in urine
- Where
- Egypt
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
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
Prematurity, Low Birth Weight Neonates
Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants
One million premature babies die due to prematurity complications, contributing the most to the causes of death in children under 5 years old.
- Trial name
- NCT07213414
- Testing
- Probiotics
- Where
- 3 sites in Indonesia
- Volunteers
- 72 people
- Sponsor
- Hasanuddin University
Preterm Birth, Skin Hydration in Preterm Infants
Effect of a Bathing Care Package on Comfort and Skin Moisture in Preterm Infants in a Neonatal Intensive Care Unit
This completed study evaluated the effects of a bathing care package on the comfort level and skin hydration of preterm infants admitted to the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Skin Hydration in Preterm Infants, Comfort in Neonates, Bathing Care Package
- Trial name
- NICU-BATH (NCT07068737)
- Testing
- bathing care package, routine bath
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people
- Sponsor
- Kiymet Aygün
Time Perception, EEG
Neural Signatures of Processing the Temporal Features of Auditory Events: From Preterm Infancy to Adulthood
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones.
- Conditions
- Time Perception, EEG, Premature Neonates, Discrimination
- Trial name
- PremaTempo (NCT04270734)
- Testing
- EEG, NIRS
- Where
- France
- Volunteers
- 240 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Time Perception, Rhythm
Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones.
- Conditions
- Time Perception, Rhythm, EEG, fNIRS
- Trial name
- Exposition (NCT05417542)
- Testing
- EEG, NIRS
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Magnetoencephalography, Optical Pump Magnetometer
Magnetoencephalography by Optical Pumping Magnetometer
MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG).
- Conditions
- Magnetoencephalography, Optical Pump Magnetometer, Neonate, Premature
- Trial name
- MEG OPM (NCT05835817)
- Testing
- Magnetoencephalography
- Where
- France
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Osteopathy, PreTerm Neonate
The Effect of Cranial Osteopathy Intervention in Preterm Babies
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated.
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic
- Trial name
- NCT06967870
- Testing
- Osteopathic intervention, Home based exercise education
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Premature Neonates
Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements…
- Trial name
- SONATA (NCT06650189)
- Testing
- Music intervention
- Where
- 2 sites in Greece
- Volunteers
- 70 people
- Sponsor
- University of West Attica
Respiratory Distress Syndrome, Newborn, Endotracheal Intubation
An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.
This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital.
- Conditions
- Respiratory Distress Syndrome, Newborn, Endotracheal Intubation, Neonatal Intubation Performance, Prematurity
- Trial name
- NINJA (NCT06898801)
- Testing
- Just-in-time video training
- Where
- Ireland
- Volunteers
- 140 people
- Sponsor
- University College Dublin
Feeding Intolerance in Preterm, NEC
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance
- Conditions
- Feeding Intolerance in Preterm, NEC, Electrical Cardiometry, PreTerm Neonate
- Trial name
- NCT06874153
- Where
- Egypt
- Volunteers
- 42 people
- Sponsor
- Ain Shams University
Neonatal Intensive Care Unit, PreTerm Neonate
Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
This study evaluates the effects of a Structured Maternal Voice Program (SMVP). on premature infant responses and maternal-infant attachment in the intensive care unit (NICU) .
- Conditions
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- Trial name
- SMVP-NICU (NCT06839534)
- Testing
- Structured Maternal Voice Program (SMVP)
- Where
- Thailand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Neonatal Hypothermia, Brown Adipose Tissue
Investigation of the Mechanisms of the Tendency to Hypothermia in Newborns and Premature Neonates
Newborns have thermoregulatory mechanisms that differ from those of adults. Instead of producing heat through shivering, newborns primarily rely on non-shivering thermogenesis by the brown adipose tissue.
- Conditions
- Neonatal Hypothermia, Brown Adipose Tissue, Preterm and Term Infants, Neonate
- Trial name
- NCT06803069
- Where
- 2 sites in Hungary
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pecs