Clinical trials: Pre-Term
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
SARS-CoV-2
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
- Trial name
- NCT06333704
- Testing
- SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5
- Where
- 26 sites in South Korea
- Volunteers
- 4,207 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Premature Ejaculation
A Safety and Tolerability Study of Administration of PSD502
A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6…
- Trial name
- NCT01183208
- Testing
- Intervention A, Intervention B, Intervention C
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Plethora Solutions Ltd
Obstetric Labour, Premature, Premature Labor
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.
- Trial name
- NCT00457925
- Testing
- GSK221149A
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infant Development
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
- Trial name
- NCT03991949
- Testing
- Experimental Infant Formula
- Where
- 7 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering…
- Trial name
- MEDI8897 Ph2b (NCT02878330)
- Testing
- MEDI8897
- Where
- 161 sites in United States, Argentina and 21 more
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Premature Ejaculation
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device.
- Trial name
- NCT03174470
- Testing
- TENS Stimulator
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Virility Medical Ltd.
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Preeclampsia (PE)
Non-Invasive Preeclampsia Screening and Biobank
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
- Trial name
- NCT06643741
- Where
- 21 sites in United States
- Volunteers
- 6,550 people, healthy volunteers welcome
- Sponsor
- Sequenom, Inc.
Threatened Preterm Labor
FB-CT2 Includes Two Prospective, Multi-centre Studies With a Medical Device in Hospital Settings: a Randomized, Dual-arm, Open-label Pilot Study in Spain, Followed by a Single-arm, Non-randomized, Open-label International Pivotal Study
The goal of this clinical trial is to evaluate the safety and the ability of a clinical investigation device (Cervisense TPTL) to predict the risk of spontaneous preterm birth in pregnant women with symptoms of threatened preterm…
- Trial name
- FB-CT2 (NCT06968364)
- Testing
- Cervisense Intravaginal Probe V0.1 cervical stiffness evaluation., Transvaginal ultrasound
- Where
- 14 sites in Spain
- Volunteers
- 457 people, healthy volunteers welcome
- Sponsor
- Ultrasound-Innovation Medtech, S.L.
Pregnancy
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication).
- Trial name
- NCT00086177
- Testing
- 8% progesterone vaginal gel
- Where
- 45 sites in United States
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.
Obstetric Labour, Premature
This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.
This will be a randomized, placebo-controlled, single, oral dose, four-way Williams crossover study design in healthy male and female subjects.
- Trial name
- NCT01702376
- Testing
- Retosiban 100 mg, Retosiban 800 mg, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Erectile Dysfunction
A Study to Evaluate Intravaginal Ejaculation Time in Men With and Without Premature Ejaculation
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to…
- Trial name
- NCT00210678
- Testing
- No intervention
- Volunteers
- 1,115 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Preterm Birth, Cervical Incompetence
Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study
The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating…
- Conditions
- Preterm Birth, Cervical Incompetence, Cervical Insufficiency, Short Cervix
- Trial name
- NCT05512052
- Testing
- Hannah Cervical Cup (2 mm Delta), Hannah Cervical Cup (4 mm Delta), Hannah Cervical Cup (6 mm Delta)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Galena Innovations, LLC
Premature Ejaculation
Evaluation of the Safety and Effectiveness of the vPatch Device
Multi-center, international, prospective, randomized, double-blind, two-arms, sham-controlled, first-in-human clinical investigation.
- Trial name
- NCT03942367
- Testing
- Active Device (vPatch)
- Where
- 3 sites in Israel, Italy
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Virility Medical Ltd.
Pre Term Labor, Multiple Pregnancy
Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.
- Trial name
- NCT01360905
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Preterm Delivery, Short Cervix
PREGNANT Short Cervix Trial
The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.
- Conditions
- Preterm Delivery, Short Cervix, Short Uterine Cervical Length
- Trial name
- NCT00615550
- Testing
- progesterone
- Where
- 49 sites in United States, Belarus and 8 more
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.