Clinical trials: Premature Neonates
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
Intrauterine Growth Retardation, Prematurity
Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care
The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome.
- Trial name
- NCT00914108
- Testing
- Newborn Individualized Developmental Care
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life…
- Trial name
- NCT01383850
- Testing
- NCPAP + standard air, NCPAP + Heliox
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sepsis, Infections
Bacillus Cereus Invasive Infections in Preterm Neonates Hospitalized in French Hospitals
Background. Bacillus cereus group (Bc) comprises twenty-six closely related species of spore-forming environmental bacteria. Recently, increased sepsis and septic shock caused by Bc were reported in preterm neonates (PN), and the…
- Trial name
- NCT06973174
- Testing
- Premature neonates with invasive infection caused by Bacillus cereus
- Where
- 13 sites in France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Infants
The Effects of "Oral Administration of Breast Milk Droplets" and "Palatal Stimulation With a Finger"
The aim of this study was to investigate the effects of "oral administration of breast milk droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with orogastric tube feeding.
- Trial name
- NCT06447558
- Testing
- palatal stimulation with a finger in premature infants
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Istanbul Medipol University Hospital
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Prematurity; Extreme, Inflammation
Anakinra for Preterm Infants Pilot
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
- Trial name
- NCT05280340
- Testing
- Anakinra
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Monash Medical Centre
Retinopathy of Prematurity
Efficacy and Safety of Mydriatic Microdrops Compared With Standard Drops for Retinopathy of Prematurity (ROP) Screening: a Pilot Randomized Clinical Trial
The purpose is to assess whether the use of microdrop instillation of phenylephrine 1.67% and tropicamide 0.33% maintains mydriatic efficacy while presents an improved safety profile compared with standard drops of phenylephrine…
- Trial name
- NCT04623684
- Testing
- Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)], Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]
- Where
- Greece
- Volunteers
- 25 people
- Sponsor
- Aristotle University Of Thessaloniki
Premature Birth of Newborn
Kangaroo Care and Premature Infant Sleep
90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then KC group was placed in KC…
- Trial name
- NCT02473055
- Testing
- Kangaroo Care
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Case Western Reserve University
Patent Ductus Arteriosus
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01536158
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Invasive Ventilation, Infant Pain
Dexmedetomidine for Invasive Ventilation In the NEOnate
Despite the increasing use of non-invasive ventilation, a large majority of premature neonates still receive invasive ventilation during their NICU (neonatal intensive care unit) stay.
- Conditions
- Invasive Ventilation, Infant Pain, Infant Discomfort, Infant Neurodevelopment
- Trial name
- NCT07493785
- Testing
- Dexmedetomidine Injectable Solution, Glucose 5% Injectable Solution
- Where
- 12 sites in France
- Volunteers
- 246 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Drug Safety
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.
- Trial name
- NCT06889376
- Testing
- Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Preterm Birth, Bronchopulmonary Dysplasia
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the urea cycle-nitric oxide pathway…
- Conditions
- Preterm Birth, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
- Trial name
- IMPROV (NCT01460576)
- Where
- 2 sites in United States
- Volunteers
- 253 people
- Sponsor
- Vanderbilt University Medical Center
Preterm, Parent-Child Relations
Sensory Optimization of the Hospital Environment
The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often…
- Conditions
- Preterm, Parent-Child Relations, Parents, Development, Infant
- Trial name
- SOOTHE (NCT05230199)
- Testing
- SENSE multisensory program, Monitored standard of care
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- University of Southern California
Premature Birth, Mothers of Newborn Infants
Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol
Mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; This requires promoting the positive perception of maternal self-efficacy and thus achieving the…
- Trial name
- NCT06420635
- Testing
- Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children, Traditional kangaroo program
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Universidad de la Sabana
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Neolifes Heart - Pulmonary Hypertension in Preterm Children
NeoLifeS is a cohort follow up study that prospectively collects data of regular care of children born preterm in the University Medical Center Groningen (UMCG) and aims to improve the quality of care for these children.
- Trial name
- NCT02729844
- Where
- Netherlands
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Cardiac Disease, Respiratory Disease
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases
- Trial name
- BRIDGE (NCT05319236)
- Testing
- Gabi System
- Where
- 4 sites in United States, Belgium
- Volunteers
- 101 people
- Sponsor
- Gabi SmartCare
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
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