Clinical trials: Preterm Infants, active
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
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
Premature Birth, Premature Infant
Growing Little PEAPODS Study
The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth…
- Conditions
- Premature Birth, Premature Infant, Premature, Intrauterine Growth Restriction
- Trial name
- NCT06226051
- Testing
- PEAPOD Infant Body Composition measuring device
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Wisconsin, Madison
Spastic Diplegia, Periventricular Leukomalacia
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia
This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.
- Trial name
- NCT03672877
- Testing
- Intensive exercise
- Where
- 2 sites in Canada
- Volunteers
- 60 people
- Sponsor
- University of Alberta
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
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
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
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
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
Prematurity, Low Birth Weight
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia
- Trial name
- NCT07834008
- Testing
- step-by-step parent education, active father participation in breastfeeding support
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University Shuang Ho Hospital
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
Preterm
Co-regulation and Interaction in the NICU
Preterm infants are exposed to multiple stressors each day, posing a risk of toxic stress that can impact their developing brains during a critical period of sensitivity.
- Trial name
- CORI (NCT06753435)
- Where
- Sweden
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Linkoeping University
Malaria, Sexually Transmitted Diseases
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health…
- Conditions
- Malaria, Sexually Transmitted Diseases, Preterm Birth, Pregnancy
- Trial name
- NCT00131235
- Testing
- Sulfadoxine-pyrimethamine treatment twice during pregnancy, Sulfadoxine-pyrimethamine at 4-week intervals, Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice
- Where
- Malawi
- Volunteers
- 1,320 people, healthy volunteers welcome
- Sponsor
- Tampere University
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
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses.
- Conditions
- Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection
- Trial name
- Volem (NCT06334523)
- Testing
- Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
- Where
- 4 sites in France
- Volunteers
- 144 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
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
Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy
Significance of Ultrasound Combined with Near-Infrared Spectroscopy in Monitoring Transfusion-Associated Intestinal Injury in Extremely Preterm Infants: a Study Protocol for a Prospective, Observational Study
Background: Most preterm infants with a gestational age <32 weeks in the neonatal intensive care unit (NICU) undergo blood transfusion therapy during their hospital stay to enhance their oxygen-carrying capacity and improve the…
- Trial name
- NCT06857812
- Testing
- there is no intervention
- Volunteers
- 100 people
- Sponsor
- Peking University Third Hospital