Clinical trials: Premature Neonates
Premature Birth
Neonatal Precursors of Neurodevelopment
The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity…
- Trial name
- NEOPRENE (NCT04703010)
- Testing
- Electroencephalography-Near infrared spectroscopy, Magnetic resonance imaging, Psychometric testing
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Caen
Bronchopulmonary Dysplasia
Biomarkers and Volumetric Capnography in BPD
The purpose of this study is to assess the association of biomarkers on day 7 of life with the development of bronchopulmonary dysplasia in very preterm infants.
- Trial name
- BPD-2014 (NCT02083562)
- Where
- 2 sites in Switzerland
- Volunteers
- 210 people
- Sponsor
- University Hospital, Basel, Switzerland
Infant, Premature, Diseases, Respiratory Distress Syndrome
Pain Assessment During Less-Invasive-Surfactant-Administration
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration…
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Pain
- Trial name
- PALISA (NCT06150586)
- Testing
- Skin Conductance (SC) Measurement, Video Recording
- Where
- Switzerland
- Volunteers
- 21 people
- Sponsor
- University of Zurich
Infant, Premature
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an…
- Trial name
- NCT03344991
- Testing
- Cardboard Cot Care, Open Crib
- Sponsor
- University of Alabama at Birmingham
Neonatal Disease
Intestinal Genes Expression Associated With Necrotizing Enterocolitis
In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade.
- Trial name
- NCT04073342
- Testing
- Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
- Volunteers
- 1 people
- Sponsor
- Assiut University
Pulmonary Hypertension, Preterm Infant
Registry of Preterm Newborns With Severe Pulmonary Hypertension
The purpose of this prospective research registry is to collect data on treatment strategies and outcomes for premature newborns with severe pulmonary hypertension (PH).
- Trial name
- NCT03310346
- Where
- United States
- Volunteers
- 232 people
- Sponsor
- University of Colorado, Denver
Necrotising Enterocolitis, Late-Onset Neonatal Sepsis
Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS).
- Trial name
- NEC (NCT04792918)
- Where
- 2 sites in Switzerland
- Volunteers
- 81 people
- Sponsor
- Emma Marie Caroline Slack
Positive Pressure Ventilation, Preterm Infants
Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes
Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while…
- Conditions
- Positive Pressure Ventilation, Preterm Infants, Apnea
- Trial name
- ForVol (NCT06161389)
- Testing
- Partially inflated mask, Fully inflated mask
- Where
- Italy
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Neonatal Respiratory Distress
Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery…
- Trial name
- VOLT (NCT05144724)
- Testing
- Volume targeted ventilation, Pressure targeted ventilation
- Where
- Canada
- Volunteers
- 52 people
- Sponsor
- University of Alberta
Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during…
- Trial name
- NeoCirc-002 (NCT06878742)
- Testing
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
Preterm Delivery
Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP)
Birth exposes the newborn to oxidative stress, as due to the switch from a protected, relatively hypoxic intrauterine milieu into an environment with a high oxygen pressure.
- Trial name
- NCT03596125
- Testing
- N-acetylcysteine
- Where
- France
- Volunteers
- 39 people
- Sponsor
- Nantes University Hospital
Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome
Multimodal Monitoring of Fetal Risk of Inflammation in Preterm Premature Rupture of Membranes
The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high…
- Conditions
- Preterm Premature Rupture of Membranes, Fetal Inflammatory Response Syndrome, Early Onset Neonatal Sepsis, Infection of Amniotic Cavity
- Trial name
- MuMFI-PPROM (NCT02702297)
- Testing
- single arm
- Where
- 4 sites in Germany
- Volunteers
- 57 people
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
Premature Birth of Newborn
Improving Preterm Infant Outcomes With Family Integrated Care and Mobile Technology
The purpose of this study is to compare the standard of care in the neonatal intensive care unit (NICU), known as Family Centered Care, to a new model of care, called mobile enhanced Family Integrated Care.
- Trial name
- mFI-Care (NCT03418870)
- Testing
- Family Integrated Care
- Where
- 6 sites in United States
- Volunteers
- 347 people
- Sponsor
- University of California, San Francisco
Premature Birth, Neurodevelopmental Disorders
Probiotics Supplementation for Neurodevelopment in Preterm Infants
The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure.
- Conditions
- Premature Birth, Neurodevelopmental Disorders, Dysbiosis
- Trial name
- NCT07617181
- Testing
- Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Fudan University
Prematurity, Respiratory Distress Neonatal
Effect of Automated Oxygen Control on Early-childhood Lung Mechanics
Preterm infants are at higher risk of long-term respiratory problems and abnormal lung function in childhood. Respiratory support including mechanical ventilation, that is the use of a machine to move air into and out of the…
- Conditions
- Prematurity, Respiratory Distress Neonatal, Oxygen Delivery
- Trial name
- NCT07866820
- Testing
- Forced oscillometry technique
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- King's College Hospital NHS Trust
Perinatal Mortality, Stillbirth
Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality
The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through…
- Conditions
- Perinatal Mortality, Stillbirth, Neonatal Mortality
- Trial name
- NCT00133744
- Testing
- folic acid, folic acid plus iron, supplements with multiple vitamins and minerals
- Where
- 5 sites in China
- Volunteers
- 18,962 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Retinopathy of Prematurity
Safety and Efficacy of Propranolol 0.2% Eye Drops in Treating Retinopathy of Premature: A Pilot Study (DROP-ROP-0.2%)
The aim of the present study is to evaluate the safety and efficacy of propranolol 0.2% eye drops in treating preterm newborns with a precocious stage of retinopathy of prematurity (ROP).
- Trial name
- NCT02504944
- Testing
- Propranolol 0.2% eye drops
- Where
- 7 sites in Italy
- Volunteers
- 98 people
- Sponsor
- Meyer Children's Hospital IRCCS
Persistent Ductus Arteriosus, Complication of Prematurity
The Preterm Infants' Paracetamol Study
Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (<24 h) intravenous paracetamol therapy for pain medication in very small premature infants.
- Conditions
- Persistent Ductus Arteriosus, Complication of Prematurity, Pain or Discomfort in Intensive Care of Preterm Infants
- Trial name
- PreParaS (NCT01938261)
- Testing
- paracetamol, 0.45 % saline solution
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- University of Oulu
Infant, Very Low Birth Weight
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Trial name
- NCT00760942
- Testing
- Similac special care 30, Similac human milk fortifier
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Oklahoma
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