Clinical trials: Premature Birth of Newborn
Infant, Premature, Diseases, Respiratory Tract Diseases
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support
- Conditions
- Infant, Premature, Diseases, Respiratory Tract Diseases, Cerebral Blood Flow
- Trial name
- NCT05592431
- Testing
- High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE), High Frequency Oscillatory Ventilation (SLE6000;SLE)
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Apnea of Prematurity, Desaturation of Blood
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%.
- Conditions
- Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing
- Trial name
- NCT03695900
- Testing
- Targeting SpO2 at 93-95%, Targeting SpO2 at 90-92%
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- University of Miami
Infant, Premature, Diseases, Airway Morbidity
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum.
- Conditions
- Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication
- Trial name
- NCT05030337
- Testing
- Closed-loop automated oxygen control (Oxygenie, SLE 6000)
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- King's College Hospital NHS Trust
Respiratory Distress Syndrome, Newborn
Delivery Room Management Trial of Premature Infants at High Risk of Respiratory Distress Syndrome
The best mode of delivery room stabilization for premature infants at high risk for respiratory distress syndrome is unknown. The protocol evaluates the impact of three distinct methods of post-delivery stabilization and…
- Trial name
- NCT00244101
- Testing
- PS Group, NCPAP Group, ISX Group
- Where
- United States
- Volunteers
- 648 people
- Sponsor
- Vermont Oxford Network
Transient Tachypnea of the Newborn, Fluid Therapy
Restricted Fluid Therapy for Newborn Breathing Problems
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF).
- Trial name
- NCT07549945
- Testing
- restricted fluid regimen, Standart fluid
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Hitit University
Hypothyroxinemia
L-Thyroxine Supplementation for Preterm Newborns Less Than 32 Weeks of Gestation With Hypothyroxinemia
Transient hypothyroxinemia of prematurity (THOP) is associated with neurodevelopmental impairment in preterm newborns < 32 weeks of gestation (WG).
- Trial name
- NCT01306227
- Testing
- L-Thyroxine, water
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Retinopathy of Prematurity
Pharmacokinetics and Safety of Dexamethasone Eye Drops in Preterm Infants
Background and study aims When an infant is born premature, the blood vessels in the eyes have not developed fully on the retina, and can start to grow incorrectly and result in blindness.
- Trial name
- NCT05387941
- Testing
- Dexamethasone Ophthalmic
- Where
- 2 sites in Sweden
- Volunteers
- 11 people
- Sponsor
- Region Skane
Retinopathy of Prematurity
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP).
- Trial name
- RoProp (NCT03083431)
- Testing
- Propranolol
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 276 people
- Sponsor
- University of Zurich
Preterm Infant, Low Birth Weight Infant
m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India
The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care…
- Conditions
- Preterm Infant, Low Birth Weight Infant, Kangaroo Mother Care, Hypothermia, Newborn
- Trial name
- NCT04929977
- Testing
- Wearable device with smart mobile phone
- Where
- India
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- St. John's Research Institute
Infant, Premature, Diseases
Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates
An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.
- Trial name
- NCT04807088
- Testing
- Tactile-kinesthetic Stimulation
- Where
- Indonesia
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
PreTerm Birth, PreTerm Neonate
Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate
To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.
- Trial name
- NCT00579839
- Testing
- Delayed Cord Clamping, Immediate Cord Clamping
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Pulmonary Hypertension, Bronchopulmonary Dysplasia
The Role of Transthoracic Echocardiography in Diagnosis of Pulmonary Hypertension of Infants With Bronchopulmonary Dysplasia
Pulmonary hypertension may develop in premature newborn infants due to impaired lung development. The diagnosis of this disease can actually be made with interventional methods.
- Trial name
- NCT05082272
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Kayseri City Hospital
Hypoxia Neonatal, Premature
Pulse Oximetry Measurement and Transfusions
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Trial name
- POMAT (NCT04249193)
- Testing
- Transfusion
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Christiana Care Health Services
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on controlled remote monitoring and optimization of oxygen therapy for premature infants in the Czech Republic.
- Trial name
- NCT07161908
- Testing
- Pulse oximeter
- Where
- 4 sites in Czechia
- Volunteers
- 70 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Neonates and Preterm Infants, Neonates or Premature Babies
Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking.
- Trial name
- CONEXUS (NCT06940713)
- Testing
- Imaging Time
- Where
- France
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Cerebral Palsy, Infant, Newborn, Disease
Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant, Newborn, Disease, Infant, Small for Gestational Age, Infant Asphyxia
- Trial name
- NCT04035291
- Testing
- exercise
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Sanko University
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
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