Clinical trials: Preterm Neonate
Respiratory Distress Syndrome, Newborn
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo…
- Trial name
- NCT00139256
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Emory University
Premature, Premature Birth
Parental Participation on the Neonatal Ward - the neoPARTNER Study
Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to…
- Conditions
- Premature, Premature Birth, Prematurity, Perinatal Problems
- Trial name
- neoPARTNER (NCT05343403)
- Testing
- Family Integrated Care
- Where
- 10 sites in Netherlands
- Volunteers
- 613 people
- Sponsor
- Onze Lieve Vrouwe Gasthuis
Very Preterm Infants
Plasma Protein Levels and Very Preterm Birth
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition.
- Trial name
- ProHémie (NCT02007902)
- Testing
- Evaluation of the relationship plasma protein levels - neonatal hemodynamics
- Where
- 2 sites in France
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Apnea of Prematurity, Retinopathy of Prematurity
Use of Sucrose to Relieve Pain During Eye Exams in Infants
The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a…
- Conditions
- Apnea of Prematurity, Retinopathy of Prematurity, Pain
- Trial name
- NCT00161694
- Testing
- sucrose solution
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Weill Medical College of Cornell University
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
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Neonatal Hypoglycemia, Neonatal Hyperglycaemia
Glucose Disturbances in Premature Infants and Quality of Life
The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years
- Trial name
- NCT04770636
- Where
- Croatia
- Volunteers
- 150 people
- Sponsor
- Clinical Hospital Center Rijeka
Infant, Newborn
Investigating Changes in Vital Signs in Neonates
1 in 7 babies require neonatal care. During their time in hospital their vital signs (such as heart rate, breathing rate and oxygen saturation) are continuously monitored as part of standard care.
- Trial name
- Neo-vital (NCT06032494)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- University of Oxford
Preterm Infant, Exposure to Radiofrequency
Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate
The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically.
- Trial name
- NeuroPrem-RF (NCT03928457)
- Testing
- Parental questionnaire, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants environmental and clinical parameters
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Respiratory Failure
A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns
There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or…
- Trial name
- NeuroPAP (NCT02480205)
- Testing
- NeuroBox to deliver the NeuroPAP
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- St. Justine's Hospital
Respiration; Insufficient or Poor, Newborn, Infant,Premature
Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment
The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age.
- Trial name
- ToNIL (NCT03586856)
- Testing
- Nasal mask interface, Nasal prongs interface
- Where
- 2 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Baldvin Jonsson
Echocardiography
Normal Reference Range for Neonatal Echocardiography
Echocardiography is the main method of bedside examination of neonatal cardiac morphology, which can timely diagnose congenital heart disease and quantitatively assess its severity, but the diagnosis and evaluation process…
- Trial name
- NORRNE (NCT05462301)
- Where
- China
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Chongqing Medical University
Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants
- Conditions
- Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal
- Trial name
- RAMCAN (NCT03081611)
- Testing
- Ram cannula, Short nasal prongs
- Where
- Israel
- Volunteers
- 166 people
- Sponsor
- Rambam Health Care Campus
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
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.
Pulmonary Hypertension of Newborn
Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension
Pulmonary hypertension is high blood pressure in the arteries to the lungs. It is a serious condition. It causes the blood vessels that carry blood from the heart to the lungs to become hard and narrow.
- Trial name
- PaTTerN (NCT03132428)
- Testing
- INOmax
- Where
- 30 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mallinckrodt
Sleep Disordered Breathing, Apnea of Prematurity
The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment".
- Conditions
- Sleep Disordered Breathing, Apnea of Prematurity, Respiratory Rate, Sudden Unexpected Death in Epilepsy
- Trial name
- PARS (NCT06292299)
- Testing
- Pneumowave
- Where
- 2 sites in United Kingdom
- Volunteers
- 225 people
- Sponsor
- NHS Greater Clyde and Glasgow
Preterm Newborn
Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System
Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs.
- Trial name
- CHARLINE (NCT06281093)
- Testing
- questionary, Daily continuous recording of radiofrequency exposure levels, Follow-up of daily infants clinical parameters
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Microbiome, Neurodevelopment Outcome
The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury
Recent advances in neonatal intensive care have dramatically increased the survival rate of extremely premature infants but the number of survivors with severe morbidity and lifelong neurodevelopmental impairment remains high.
- Conditions
- Microbiome, Neurodevelopment Outcome, Immunology
- Trial name
- PreMiBraIn (NCT03213275)
- Testing
- Microbiome Sequencing, Neurophysiologic Assessment, Immunological test
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Medical University of Vienna
Congenital Heart Defect, Respiratory Distress Syndrome in Premature Infant
Neonatal Cardio-Pulmonary Outcome Measure
Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU).
- Trial name
- N-COM (NCT04324957)
- Testing
- Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Asir John Samuel
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