Clinical trials: Premature Birth
Preterm Delivery
Neonatal Outcome by Reason for Delivery
To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM).
- Trial name
- NCT01818518
- Where
- 10 sites in United States
- Volunteers
- 995 people, healthy volunteers welcome
- Sponsor
- Obstetrix 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
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
- Conditions
- Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ventricular Tachycardia
- Trial name
- COSMOS (NCT05373862)
- Testing
- Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
- Where
- 4 sites in Belgium, Croatia and 1 more
- Volunteers
- 40 people
- Sponsor
- Biosense Webster, Inc.
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
Retinopathy of Prematurity
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP).
- Trial name
- BUTTERFLEYE (NCT04101721)
- Testing
- aflibercept, laser photocoagulation
- Where
- 52 sites in United States, Bulgaria and 11 more
- Volunteers
- 127 people
- Sponsor
- Regeneron Pharmaceuticals
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks…
- Trial name
- NCT02074059
- Testing
- Lucinactant for Inhalation, nCPAP alone
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Windtree Therapeutics
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Respiratory Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Respiratory Distress Syndrome, Newborn
Comparison of CPAP Machines With Reusable vs Disposable Circuits
The study aims to assess the basic functionality of a newly designed CPAP machine with reusable circuits to existing machines with disposable circuits, for treatment of newborn infants diagnosed with respiratory distress…
- Trial name
- NCT03121612
- Testing
- CPAP
- Where
- India
- Volunteers
- 51 people
- Sponsor
- Medical Technology Transfer and Services Hong Kong Ltd
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Premature Ejaculation
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
- Trial name
- NCT02232425
- Testing
- IX-01
- Where
- 10 sites in United States, Australia
- Volunteers
- 88 people
- Sponsor
- Ixchelsis Limited
Muscular Dystrophy, Duchenne, Muscular Dystrophies
An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren…
- Conditions
- Muscular Dystrophy, Duchenne, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases
- Trial name
- NCT02090959
- Testing
- Ataluren
- Where
- 58 sites in United States, Australia and 17 more
- Volunteers
- 219 people
- Sponsor
- PTC Therapeutics
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Retinopathy of Prematurity
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
- Trial name
- RAINBOW (NCT02375971)
- Testing
- Ranibizumab, Laser therapy
- Where
- 86 sites in United States, Austria and 24 more
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Premature Birth of Newborn, Intestinal Malabsorption
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
- Trial name
- NCT02510560
- Testing
- NTRA-2112
- Where
- 50 sites in United States, Belgium and 8 more
- Volunteers
- 300 people
- Sponsor
- Elgan Pharma Ltd.
Necrotizing Enterocolitis
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.
- Trial name
- NCT01954017
- Testing
- STP206, Control
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Leadiant Biosciences, Inc.