Clinical trials: Premature Birth of Newborn, open to volunteers
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
Infant, Premature, Diseases, Premature Birth of Newborn
Elevated Midline Positioning During Diaper Change in Preterm Infants
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants.
- Conditions
- Infant, Premature, Diseases, Premature Birth of Newborn, Pain
- Trial name
- NCT07865897
- Testing
- 30-Degree Elevated Midline Positioning, Standard Lateral Position Diaper Change
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
Bronchopulmonary Dysplasia (BPD)
Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants
The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).
- Trial name
- PRELUDE (NCT07652684)
- Testing
- Enteral supplementation with ARA and DHA (in a 2:1 ratio) in addition to standard care and feeding, Standard care and feeding
- Where
- Greece
- Volunteers
- 74 people
- Sponsor
- Aristotle University Of Thessaloniki
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Bronchopulmonary Dysplasia (BPD)
Metformin for Premature Infants With Bronchopulmonary Dysplasia
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study.
- Trial name
- NCT07120971
- Testing
- Metformin (open-label)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Neonatal Pain, Retinopathy of Prematurity (ROP)
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm…
- Conditions
- Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature
- Trial name
- FIREFLY (NCT07112430)
- Testing
- Fentanyl Citrate (Intranasal)
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- Marsha Campbell-Yeo
Preterm
The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation
It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to…
- Trial name
- NCT06832553
- Testing
- surgical incision drep
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Hasan Kalyoncu University
Respiratory Distress Syndrome in Premature Infant
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will…
- Trial name
- REMEDIES (NCT05791331)
- Testing
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Ventilator Pressure and Optimization of Compliance and Hemodynamics
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and…
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn
- Trial name
- VPOCH (NCT06512935)
- Testing
- Increase in the PEEP followed by decrease in the PEEP, Decrease in the PEEP followed by increase in the PEEP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Alabama at Birmingham
Bronchopulmonary Dysplasia
Early Predictors of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care.
- Trial name
- EPIRESP (NCT07771387)
- Where
- Austria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Retinopathy of Prematurity (ROP), Premature Birth
Long-term Ophthalmic Outcomes in Ex-premature Infants
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.
- Trial name
- LTOO-XP (NCT06649513)
- Testing
- eye drops (Tropicamid)
- Where
- Netherlands
- Volunteers
- 210 people
- Sponsor
- Erasmus Medical Center
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Respiratory Distress Syndrome of Newborn
- Trial name
- NCT07550218
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Preterm Birth, Feeding Methods
How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant
Very low-birth-weight premature infants (VLBWs) are fed via nasal or oro-gastric tube for a long time because of the physiological inability to coordinate swallowing, sucking, and breathing until at least 34 weeks of gestational…
- Trial name
- NCT06760832
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Fetal Growth Restriction (FGR), Preterm Birth
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Pregnancy complications such as pre-eclampsia (high blood pressure during pregnancy), poor fetal growth, unexplained stillbirth, and spontaneous preterm birth are major causes of illness and death for mothers and babies in…
- Conditions
- Fetal Growth Restriction (FGR), Preterm Birth, Still Births, Abruptio Placentae
- Trial name
- EPAPOA (NCT07844876)
- Where
- 2 sites in Uganda
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Makerere University
Bronchopulmonary Dysplasia (BPD)
Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity.
- Trial name
- ELVIRE (NCT07487259)
- Testing
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Infant, Premature
Automated Oxygen Control in Preterms on Non-invasive Ventilation
This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of…
- Conditions
- Infant, Premature, Airway Morbidity
- Trial name
- NCT07622563
- Testing
- Closed loop automated oxygen control
- Where
- United Kingdom
- Volunteers
- 76 people
- Sponsor
- King's College Hospital NHS Trust
Lymphedema, Premature Birth
Infant Massage for Lymphedema and Comfort in Preterm Newborns
This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care…
- Conditions
- Lymphedema, Premature Birth, Edema, Immobilization
- Trial name
- NCT07418814
- Testing
- Infant Massage Group
- Volunteers
- 40 people
- Sponsor
- Erzurum Technical University
Skin Injury, Premature Birth
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Pulse oximeter probes are used to continuously monitor oxygen levels in newborn babies in intensive care. These probes are usually attached to the baby's hand or foot with adhesive tape and must be moved to a new site every few…
- Conditions
- Skin Injury, Premature Birth, Medical Adhesive Related Skin Injury
- Trial name
- NCT07864298
- Testing
- Cohesive bandage fixation of pulse oximeter probe, Standard adhesive fixation of pulse oximeter probe
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people
- Sponsor
- Uskudar University