Clinical trials: Premature
Preterm Labor, Preterm Birth
Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.
- Trial name
- PRIME (NCT04301518)
- Testing
- Multimodal intervention strategy
- Where
- 18 sites in United States
- Volunteers
- 6,500 people, healthy volunteers welcome
- Sponsor
- Sera Prognostics, Inc.
Preterm Birth
Predictive Value of Maternal Blood Protein Signatures in Preterm Birth
Accurate prediction of preterm birth is critical for clinical management to improve the neonatal and maternal outcomes. A clinical challenge remains for current predicting biomarkers due to the complexity and multifactorial…
- Trial name
- NCT06664554
- Where
- 5 sites in China
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Preterm Labor, PreTerm Birth
Electrical Inhibition of Human Preterm Contractions
The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration…
- Conditions
- Preterm Labor, PreTerm Birth, Preterm Labor With Delivery Nos
- Trial name
- NCT02983240
- Testing
- Electrical Uterine Pacemaker
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- e-Bio Corp
Preterm Labor, Preterm Birth
MIRACLE of LIFE Study
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1.
- Conditions
- Preterm Labor, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane
- Trial name
- MoL (NCT06074601)
- Testing
- Mirvie Predictive Test for Adverse Pregnancy Outcomes
- Where
- 10 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Mirvie
Pre-eclampsia, Preterm Birth
Maternal Serum Markers Predicting Preeclampsia At Early Gestations
This observational study aims to assess the effectiveness of a maternal blood test as a prognostic tool for predicting early pregnancy risk of preeclampsia (PE).
- Trial name
- NCT05131282
- Testing
- Blood test of PE risk, Blood test of Preterm PE risk
- Where
- 6 sites in China
- Volunteers
- 18,000 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Sexual Dysfunction, Physiological
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.
- Trial name
- NCT01063881
- Testing
- Dapoxetine
- Where
- 13 sites in Australia, South Korea and 1 more
- Volunteers
- 285 people
- Sponsor
- Janssen Research & Development, LLC
Cardiac Arrhythmia
EnSite Precision Observational Study
This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software…
- Trial name
- NCT03260244
- Testing
- cardiac mapping and radiofrequency ablation procedure
- Where
- 7 sites in United States
- Volunteers
- 1,065 people
- Sponsor
- Abbott Medical Devices
Premature Birth
Neonatal Pulse Oximetry Sensor Study
To validate the SpO2 accuracy, bias, and precision of Medline's reprocessed pulse oximetry sensors as compared to SaO2 in arterial blood samples as assessed by CO-oximetry in neonates.
- Trial name
- NCT05250102
- Testing
- Pulse oximeter sensors
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Medline Industries
Catheters, Indwelling, Preterm Birth
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has…
- Conditions
- Catheters, Indwelling, Preterm Birth, Compromised Health
- Trial name
- IMPROVE (NCT06616012)
- Testing
- Neosense umbilical catheter
- Where
- 6 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Neosense Technologies
Premature Ovarian Insufficiency, Diminished Ovarian Reserve
A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)
The VL-POI-01 study is designed to evaluate the safety and efficacy of human placental mesenchymal stem cell derived exosome treatment in patients with premature ovarian insufficiency (POI) and diminished ovarian reserve.
- Trial name
- VL-POI-01 (NCT06072794)
- Testing
- VL-PX10
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Vitti Labs, LLC
Premature Ejaculation, Stress
Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been…
- Trial name
- NCT06571318
- Testing
- Destress and Perform Capsule-U001, Destress and Perform Capsule-I001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Herbolab India Pvt. Ltd.
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
Premature Ejaculation, Sex Disorder
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation.
- Conditions
- Premature Ejaculation, Sex Disorder, TEN
- Trial name
- TENSPE2 (NCT06425224)
- Testing
- Tens therapy, Standard treatment (dapoxetine 30 mg as needed)
- Where
- Mexico
- Volunteers
- 129 people
- Sponsor
- Boston Medical Group
Premature Ejaculation
TPTNS for Treating Patients With Premature Ejaculation
Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are anatomically and physio-pathologically similar.
- Trial name
- NCT03204890
- Testing
- Transcutaneous Posterior Tibial Nerve Stimulation
- Where
- Colombia
- Volunteers
- 26 people
- Sponsor
- Boston Medical Group
Pregnancy Complications, Pregnancy Outcome
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
- Conditions
- Pregnancy Complications, Pregnancy Outcome, Congenital Abnormalities
- Trial name
- NCT01653392
- Testing
- Observational Intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
PreTerm Labor, Threatened Preterm Labor
Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients
This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor.
- Conditions
- PreTerm Labor, Threatened Preterm Labor, Preterm Birth
- Trial name
- NCT06157203
- Testing
- Uterine electromyography
- Where
- 2 sites in United States
- Volunteers
- 181 people, healthy volunteers welcome
- Sponsor
- PreTeL, Inc
Neonatal Respiratory Distress
Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS).
- Trial name
- NCT03582930
- Testing
- Infasurf Aero
- Where
- 5 sites in United States
- Sponsor
- ONY