Clinical trials: Delivery, Obstetric, open to volunteers
Anxiety
An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial
This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is…
- Trial name
- VITAL (NCT07064213)
- Testing
- Behavioral: Educational Video
- Where
- Israel
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Wolfson Medical Center
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
Maternal Health, Pregnancy
Understanding the Role of Doulas in Supporting People With PMADs
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility.
- Conditions
- Maternal Health, Pregnancy, Delivery, Obstetric, Self Efficacy
- Trial name
- NCT05763537
- Testing
- Standard Doula Care Plus PMAD Intervention, Standard Doula Care
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Montana
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
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
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
Macrosomia, Fetal, Large for Gestational Age
Fetal Clavicular Measurement to Predict Fetal Macrosomia
Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth.
- Conditions
- Macrosomia, Fetal, Large for Gestational Age, Shoulder Dystocia
- Trial name
- NCT06283277
- Testing
- Obstetric Ultrasound
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Assiut University
Cardiovascular Diseases
Continuation of the nuMoM2b Heart Health Study
Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in U.S. women at all ages, and large knowledge gaps exist in CVD predictive and preventative strategies for women.
- Trial name
- nuMoM2b-HHS2 (NCT05472597)
- Where
- 14 sites in United States
- Volunteers
- 4,048 people, healthy volunteers welcome
- Sponsor
- RTI International
Moral Distress
The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Due to highly specialized medical care neonatal care providers are faced with numerous responsibilities which makes neonatal care a particularly challenging and stressful work environment.
- Trial name
- MoD (NCT06836323)
- Where
- Switzerland
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
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
Stress Disorders, Post-Traumatic, Psychological Trauma
Postnatal Debriefing After Adverse Obstetric Events
Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress.
- Conditions
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period
- Trial name
- DBIRTH (NCT07579273)
- Testing
- Structured Postnatal Debriefing, Usual Care
- Volunteers
- 142 people
- Sponsor
- Parc de Salut Mar
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
Cerebral Palsy Infantile, Pre-Term
Motor-voice Assessment in Infants (MAMI)
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants..
- Conditions
- Cerebral Palsy Infantile, Pre-Term, Motor Delay, Neurodevelopmental Disorders
- Trial name
- MAMI (NCT06807203)
- Testing
- Behavioral observation
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Ohio State University
COVID-19 Pneumonia, COVID-19 Pandemic
Corona Virus Disease 2019 Cohort Study
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
- Conditions
- COVID-19 Pneumonia, COVID-19 Pandemic, COVID-19
- Trial name
- NCT06927622
- Where
- 5 sites in China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Shandong University