Clinical trials: Birth, Preterm
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Preterm Labor
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.
- Trial name
- TERM (NCT02326142)
- Testing
- OBE001
- Where
- 23 sites in Belgium, Germany and 4 more
- Volunteers
- 10 people
- Sponsor
- ObsEva SA
Preterm Infants
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium…
- Trial name
- NCT02066610
- Testing
- selenium and sodium selenate supplementation, selenium and sodium selenite supplementation, Without selenium and sodium selenate supplementation
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Abbott Nutrition
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
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
Respiratory Morbidities of Prematurity (RMP)
Open-label Study of Inhaled RVT-1601 in Preterm Infants
Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term.
- Trial name
- NCT04007120
- Testing
- RVT-1601
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Respivant Sciences GmbH
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB
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
- NCT03673579
- Testing
- NICU Dashboard
- Where
- United States
- Sponsor
- Philips Healthcare
Pregnancy
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.
- Trial name
- NCT01399229
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reproductive Research Technologies, LP
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
Premature Birth
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.
- Trial name
- NCT06063122
- Testing
- smallTalk NICU Active
- Where
- 2 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Thrive Neuromedical, LLC
Pre Term Birth
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of…
- Trial name
- NCT06668896
- Testing
- Progesterone
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, 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
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
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
Anesthesia
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks…
- Trial name
- NCT01508455
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer