Clinical trials: Premature Infant
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Respiratory Distress Syndrome in Premature Infant, Surfactant Deficiency Syndrome Neonatal
Feasibility Study - Neofact
For therapy of respiratory distress syndrome (RDS) in premature babies, there are several established options. An important therapeutic aspect is the tracheal administration of exogenous surfactant into the child's lung.
- Trial name
- NCT04086095
- Testing
- Neofact application aid
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital Tuebingen
Ventilator Lung; Newborn, Hemodynamic Instability
Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates
The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm…
- Conditions
- Ventilator Lung; Newborn, Hemodynamic Instability, Echocardiography
- Trial name
- NCT05706428
- Testing
- NHFOV, NCPAP
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Alexandria University
Premature Birth of Newborn
The Effect of Perinatal Stress on the Development of Preterm Infants
In this project, the investigators will study a cohort of preterm infants, together with their parents, during NICU hospitalization and follow their developmental trajectory until the age of two.
- Trial name
- RESILIENCE (NCT02623400)
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Apnoea, Prematurity
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
The aim of this study is to monitor the frequency of apnoeas (pauses in breathing) on various methods of non-invasive respiratory support that are detected by an automated machine-learning (ML) model based on diaphragmatic…
- Trial name
- NCT07794007
- Testing
- Diaphragmatic electromyography
- Volunteers
- 30 people
- Sponsor
- King's College Hospital NHS Trust
Lung Diseases
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.
- Trial name
- NCT00431418
- Testing
- Sildenafil
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Mercy Hospital for Women, Australia
Premature Infants, Stool Bacterial Composition
Effects of Probiotic and Prebiotic Combinations on Premature Infants
The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants.
- Conditions
- Premature Infants, Stool Bacterial Composition, Growth
- Trial name
- NCT00282113
- Testing
- ProBioPlus, Culturelle
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Prematurity, Anemia
Transfusions and Nitric Oxide Level in Preterm Infants
The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants.
- Conditions
- Prematurity, Anemia, Necrotizing Enterocolitis
- Trial name
- NCT00787124
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Preterm Birth Complication
SOon HOme Study About Preterm Infants
The goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams…
- Trial name
- SOHO (NCT06593808)
- Testing
- Weaning from the incubator to open coat at a weight greater than or equal to 1400 grams
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Preterm Infant Development, COVID - 19
Development of Preterm Infants Born During the COVID-19 Pandemic
This study aims to evaluate differences in cognitive and psychomotor development among preterm infants (born before 34 weeks of gestation) delivered during the COVID-19 pandemic at Hospital de la Santa Creu i Sant Pau, compared…
- Trial name
- NCT07569523
- Testing
- Evaluation of cognitive and psychomotor development through the Bayley Scales Of Infant and Toddler Development and Wechsler Preschool and Primary Scale of Intelligence
- Volunteers
- 120 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Premature Birth of Newborn, Enterocolitis, Necrotizing
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
The purpose of this study is to determine whether antibiotics given immediately after birth alter the development of the developing preterm infant's microbiome, which may further alter overall clinical outcomes.
- Trial name
- NCT02477423
- Testing
- Ampicillin, Gentamicins
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Music Therapy
Premature Family Music Therapy Intervention (PFMI)
The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte".
- Trial name
- PFMI (NCT04335240)
- Testing
- Premature family music therapy intervention to support parenting, attachment bond and preterm development
- Where
- Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Melatonin Production
Melatonin Production Delay in Preterm Infants
Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months of age. This might be related to exposure of preterm infants to continuous lighting in the NICU during a critical period of pineal…
- Trial name
- NCT00775723
- Where
- Israel
- Volunteers
- 46 people
- Sponsor
- Tel Aviv University
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Infant, Newborn, Diseases, Infant Development
Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g
Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32…
- Trial name
- NCT05945017
- Testing
- Infloran® -Berne, Switzerland- (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748
- Where
- Spain
- Volunteers
- 233 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Enteral Nutrition
Early Exclusive Enteral Nutrition in Early Preterm Infants
Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and…
- Trial name
- NCT03708068
- Testing
- Early exclusive enteral nutrition
- Where
- 3 sites in Canada
- Volunteers
- 69 people
- Sponsor
- Belal Alshaikh
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
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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