Clinical trials: Premature Neonates
Retinopathy of Prematurity
A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity.
A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong.
- Trial name
- NCT06288321
- Testing
- Microdrop Mydrin-P, Standard Mydrin-P
- Where
- Hong Kong
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
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
The Social Determinants of Health Screening and Referral Project
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH).
- Trial name
- NCT06582147
- Testing
- Implementation of social determinants of health screening and referral
- Where
- 7 sites in United States
- Volunteers
- 882 people
- Sponsor
- University of Massachusetts, Worcester
Neonatal Encephalopathy
Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy
The aim of our study is to evaluate the feasibility of applying transcutaneous CO2 monitoring (tcPCO2) in neonates receiving therapeutic hypothermia and to quantify the agreement between tcPCO2 and PCO2 in this population with or…
- Trial name
- NCT04603547
- Testing
- Transcutaneous Carbon Dioxide Monitoring
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Brigham and Women's Hospital
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
Safety Issues, BPD - Bronchopulmonary Dysplasia
Autologous Cord Blood Cells for Prevention of BPD in Preterm
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
- Conditions
- Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
- Trial name
- NCT04311476
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy, 0.9% Sodiun Chloride
- Where
- China
- Volunteers
- 62 people
- Sponsor
- yangjie
Anemia of Prematurity
Premature Infants in Need of Transfusion (PINT)
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity…
- Trial name
- NCT00182390
- Testing
- Red blood cell transfusion
- Where
- 10 sites in United States, Australia and 1 more
- Volunteers
- 424 people
- Sponsor
- McMaster University
Pre-Term
Optos Versus Indirect Ophthalmoscopy for ROP Screening Examination (Optos vs BIO Study)
ROP is a preventable cause of blindness in premature infants. It is routinely screened for by using an indirect ophthalmoscope, a scleral depressor, and a condensing lens.
- Trial name
- NCT04292015
- Testing
- Optos ultra-widefield retinal imaging (Optos California)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Bronchopulmonary Dysplasia
Fluid Filled Lung Oxygenation Assistance Trial
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).
- Trial name
- FFLOAT (NCT03041740)
- Testing
- Perfluorooctyl Bromide
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospital of Philadelphia
Neonates and Preterm Infants, Cardiopulmonary
Triple EIT (Electrical Impedance Tomography)
This study plans to learn more about ways to look at participant's lungs using new machines called Electrical Impedance Tomography (EIT). The EIT does not use harmful radiation like CT or x-ray.
- Trial name
- NCT07247474
- Testing
- Electrical impedance tomography (EIT)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Cerebral Oxygenation
Neonatal Cerebral Oxygenation and Changes in CPAP Flow Pressure - Evaluation With INVOS Oximeter
Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. We will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
- Trial name
- NCT01684618
- Testing
- Cerebral NIRS Oximetry + CPAP
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Neurologic Manifestations, Premature Birth
The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.
- Conditions
- Neurologic Manifestations, Premature Birth, Hypoxia-Ischemia, Brain
- Trial name
- Neu-Prem (NCT02605733)
- Testing
- EEG, NIRS
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Sharp HealthCare
Premature Infant Disease
Effects of Lactobacillus Reuteri in Premature Infants
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of…
- Trial name
- Reuteri (NCT01181791)
- Testing
- Lactobacillus reuteri
- Where
- 2 sites in Chile
- Volunteers
- 65 people
- Sponsor
- University of Miami
Premature Birth of Newborn
The Developmental Effects of NICU Positioning
The purpose of this study is to investigate the developmental effects of two different types of positioning used with premature infants in the neonatal intensive care unit.
- Trial name
- NCT01628510
- Testing
- Dandle Roo/Dandle Wrap, Traditional NICU Positioning
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
CGM Use in Preterm Infants
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- Trial name
- NCT05436925
- Testing
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Minnesota
Chorioamnionitis, Cerebral Palsy
Early Identification of Brain Insult in Chorioamnionitis
Premature breaking of the amniotic fluids during pregnancy caries high risk for infection of the amniotic fluid. One of the results of chorioamnionitis is brain injury of the fetus.
- Trial name
- NCT01778725
- Where
- Israel
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center
Maternal; Chorioamnionitis, Affecting Fetus, Early-Onset Sepses, Neonatal
A Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator
This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University…
- Trial name
- NCT04513691
- Testing
- EOS Calculator
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Pediatrix
Osteopenia Of Prematurity
A Preliminary Study of Bone Density in Neonates
The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.
- Trial name
- NCT00631397
- Testing
- Ultrasound machine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy
Investigating Cerebral Oxygenation in the Newborn
The goal of this single centre observational study is to use near-infrared spectroscopy (NIRS) monitoring to investigate cerebral oxygenation in two groups of newborn infants who are at high risk of brain injury.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Premature Infant Disease
- Trial name
- ICON (NCT05588960)
- Testing
- Near-infrared spectroscopy monitoring (Masimo O3 Regional Oximeter with Neonatal Sensor)
- Where
- United Kingdom
- Volunteers
- 99 people
- Sponsor
- University of Edinburgh
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