Clinical trials: Preterm Birth Complication
Preterm Birth
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm…
- Trial name
- 170HP (NCT00163020)
- Testing
- 17-alpha-hydroxyprogesterone caproate injectable
- Where
- 18 sites in United States
- Volunteers
- 321 people
- Sponsor
- Obstetrix Medical Group
Premature Infants
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.
- Trial name
- NCT01140243
- Testing
- LCPUFA
- Where
- 2 sites in Israel
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Materna Laboratories
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
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
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
Obstetric Labour, Premature
A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour
The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban.
- Trial name
- NCT02292771
- Testing
- Retosiban, Atosiban
- Where
- 21 sites in Belgium, Germany and 7 more
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
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
Erectile Dysfunction, Premature (Early) Ejaculation
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
- Conditions
- Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation, Pelvic Floor; Weak
- Trial name
- NCT06425211
- Testing
- Therapeutic exercises, Perineal electromyographic biofeedback, Electrical stimulation
- Where
- Colombia
- Volunteers
- 66 people
- Sponsor
- Boston Medical Group
Premature Birth
Vaginal Progesterone in Twins With Short Cervix
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
- Trial name
- NCT01812239
- Testing
- Vaginal Progesterone gel., fetal fibronectin swab.
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Preterm Birth
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34…
- Trial name
- PCP002 (NCT02225353)
- Testing
- Progesterone Cervical Pessary 6.3 g, Progesterone 200 mg vaginal capsules, Progesterone Cervical Pessary 7.7 g
- Where
- 4 sites in Chile
- Volunteers
- 271 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO
This study evaluates the use of a NICU clinical integration system (Dashboard and accessories) in improving the quality of care delivered, patient health outcomes, and parent and clinician satisfaction.
- Conditions
- Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less), Neonatal Infection, Satisfaction
- Trial name
- NCT03673566
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Preterm Delivery
Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients
The goal of the study is to determine the clinical performance of the PremaSure kit, more precisely to assess whether the PremaSure kit can be used as a self-test to assess the risk of premature delivery in patients showing…
- Trial name
- NCT07307365
- Where
- Switzerland
- Volunteers
- 800 people
- Sponsor
- Rea Diagnostics SA
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.
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
Preterm Birth
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of…
- Trial name
- PROLONG (NCT01004029)
- Testing
- Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
- Where
- 104 sites in United States, Bulgaria and 7 more
- Volunteers
- 1,740 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Birth Defects, Type 2 Diabetes
Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
This is an observational, prospective cohort study describing pregnancy outcomes in women with pre-existing (prior to pregnancy) type 2 diabetes who have been exposed to any formulation of exenatide during pregnancy.
- Conditions
- Birth Defects, Type 2 Diabetes, Preterm Birth
- Trial name
- Exenatide (NCT00579150)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- AstraZeneca
Necrotizing Enterocolitis
Monitoring Necrotizing Enterocolitis in Premature Infants
The investigators are studying a disease called "necrotizing enterocolitis" (or "NEC" for short), which affects premature infants.
- Trial name
- NCT01287559
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Spectros Corporation
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
Fetal Membranes, Premature Rupture
Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
The purpose of this study is to determine whether retention of cervical cerclage after PPROM improves latency (without a significant increase in chorioamnionitis) and lessens neonatal morbidity.
- Trial name
- PROMCerclage (NCT00201656)
- Testing
- Retention of Cerclage, Removal of Cerclage, Removal vs. Retention of Cervical Cerclage
- Where
- 23 sites in United States
- Volunteers
- 58 people
- Sponsor
- Obstetrix Medical Group
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.