Clinical trials: Labor, Obstetric
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, Inc.
Growth, Development
Preterm Infant Growth
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
- Conditions
- Growth, Development, Infant
- Trial name
- NCT01162798
- Testing
- infant formula, control infant formula
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Société des Produits Nestlé (SPN)
Vasa Previa
Optimal Management of Vasa Previa Study - A Retrospective Study
This is a multicenter retrospective observational study of women diagnosed with a vasa previa during pregnancy or at delivery who delivered between 2000 and 2012.
- Trial name
- VasaPrevia (NCT01977040)
- Where
- 9 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Obstetric Labour, Premature
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4…
- Trial name
- NCT01627587
- Testing
- GSK221149 750 mg, Ketoconazole, GSK221149 100 mg
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome (Neonatal), Intubation Complication
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated…
- Conditions
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- Trial name
- Aero-05 (NCT05960929)
- Testing
- Infasurf Aero™
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- ONY
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
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 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.
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants
The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory…
- Trial name
- NCT00497289
- Testing
- Lipofundin MCT/LCT 20 %, Lipidem 20%
- Where
- 2 sites in Germany
- Volunteers
- 48 people
- Sponsor
- B. Braun Melsungen AG
Preterm Birth
Evaluating Patterned Oral Somatosensory Entrainment Stimulation Using the NTrainer on Oral Feeding Performance
This is a research study to determine if an experimental device called the NTrainer can improve oral feeding skills more quickly and more effectively than traditional methods in infants who are at high risk of feeding dysfunction…
- Trial name
- NCT01069718
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- KC BioMediX, Inc
Premature Infant
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups.
- Trial name
- NCT03607942
- Testing
- HMO supplement
- Where
- 7 sites in France
- Volunteers
- 86 people
- Sponsor
- Société des Produits Nestlé (SPN)
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co 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 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
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
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.
Postpartum Haemorrhage
Treatment of Women After Postpartum Haemorrhage
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
- Trial name
- PP-01 (NCT01895218)
- Testing
- Iron isomaltoside 1000, Standard medical Care
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Pharmacosmos A/S
Respiratory Distress Syndrome
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
- Trial name
- NCT00807235
- Testing
- Aerosolized lucinactant
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Windtree Therapeutics
Blood Loss Massive, Trauma
QStat in Trauma and Obstetric Hemorrhage
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum hemorrhage.
- Conditions
- Blood Loss Massive, Trauma, Post Partum Hemorrhage
- Trial name
- NCT04385953
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- HemoSonics LLC