Clinical trials: Complication of Delivery
Prematurity
Effect of Osteopathic Manipulative Treatment on Pain in Preterms
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of…
- Trial name
- NCT02146677
- Testing
- Osteopathic manipulative treatment, Usual care
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- European Institute for Evidence Based Osteopathic Medicine
Preterm Infant, Umbilical Cord Milking
Effect of Intact Umbilical Cord Milking on Neonatal and First Year Neurodevelopmental Outcomes in Very Preterm Infants.
The investigators hypothesise that intact umbilical cord milking (I-UCM) will reduce neonatal morbidity and improve long term neurodevelopmental outcome in very preterm infants.
- Trial name
- Cord-milking (NCT03200301)
- Testing
- Intact Umbilical Cord Milking
- Where
- India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Jubilee Mission Medical College and Research Institute
Respiratory Distress Syndrome in Premature Infants, Very Low Birth Weight Baby
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame.
- Trial name
- iNO (NCT01220687)
- Testing
- iNO, Nitrogen
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- University of Oklahoma
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
Sepsis, Pre-Term
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)
The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset…
- Conditions
- Sepsis, Pre-Term, Late-Onset Neonatal Sepsis
- Trial name
- OMEPS (NCT04717037)
- Testing
- Olive Oil Massage
- Where
- 2 sites in Saudi Arabia
- Volunteers
- 300 people
- Sponsor
- King Abdullah International Medical Research Center
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
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
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
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
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
Pre-Term, Breast Milk Expression
Preemie Milk Analyser Validation Study
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies.
- Conditions
- Pre-Term, Breast Milk Expression, Nutrition Disorder, Infant
- Trial name
- NCT06486194
- Testing
- Targeted breast milk fortification using preemie device, Standard Breast milk fortification
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Premature; Infant, Light-for-dates, Breastfeeding
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly…
- Trial name
- ProPre (NCT01454661)
- Testing
- LGG, LGG+Bb-12
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Persistent Ductus Arteriosus
Betamethasone and Closure of Ductus Arteriosus
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality…
- Trial name
- CELESTE (NCT05987202)
- Testing
- DA closure in a population of premature infants
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Prematurity, Oxidative Injury
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen.
- Conditions
- Prematurity, Oxidative Injury, Respiratory Distress
- Trial name
- NCT00356902
- Testing
- titration of oxygen during resuscitation
- Where
- Canada
- Volunteers
- 215 people
- Sponsor
- University of Calgary
Post Partum Hemorrhage
Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery
Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after…
- Trial name
- NCT04353544
- Testing
- delayed cord clamping
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- Federico II University
Postpartum Hemorrhage
Investigating the Association of Shock Index and Hemoglobin Variation With Postpartum Hemorrhage After Vaginal Deliveries
Postpartum hemorrhage (PPH) is a leading cause of maternal mortality and morbidity, and is most commonly caused by poor uterine tone after delivery of the baby and placenta.
- Trial name
- NCT03432767
- Testing
- Non-invasive hemoglobin monitor
- Where
- Canada
- Volunteers
- 67 people
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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