Clinical trials: Preterm
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
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.
Preterm Birth
Impact of Pessary Treatment on Cervical Stiffness Measurement and Birth Outcomes in Patients at Risk for Preterm Birth
Background: A preterm birth remain a worldwide important socioeconomic burden since prematurity has been consistently implicated in a wide range of health medical problems affecting newborn child and contributed in up to more…
- Trial name
- NCT05267717
- Testing
- Non-interventional study, all patients being tested with AG Pregnolia System to assess the values of the Cervical Stiffness
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Asklepios proresearch
Preterm Infants
HMF Preterm Case Studies
Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a…
- Trial name
- NCT05057390
- Testing
- New Human Milk Fortifier (NHMF)
- Where
- 4 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Nutricia UK Ltd
Preterm Birth
Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery
Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine.
- Trial name
- CM (NCT04247555)
- Where
- 2 sites in United States
- Volunteers
- 270 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Preterm Infant
The FOUNDATION Study
The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint.
- Trial name
- FOUNDATION (NCT03939546)
- Testing
- B. infantis EVC001
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Evolve BioSystems, Inc.
Preterm Labor
PoC Study of OBE022 in Threatened Preterm Labour
This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between…
- Trial name
- PROLONG (NCT03369262)
- Testing
- OBE022, Atosiban
- Where
- 18 sites in Czechia, Finland and 4 more
- Volunteers
- 115 people
- Sponsor
- ObsEva SA
Preterm Birth
A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation.
- Trial name
- TREETOP (NCT02787213)
- Where
- 18 sites in United States
- Volunteers
- 5,011 people
- Sponsor
- Sera Prognostics, Inc.
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
Antioxidant Role of the Lutein in Preterm Newborn
Early Administration of the Lutein/Zeaxanthin in Premature Newborns
Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system…
- Trial name
- NCT03340103
- Testing
- LUTEIN ofta 0,5 gocce
- Where
- 4 sites in Italy
- Sponsor
- Sooft Italia
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 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
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 Infant
Growth and Safety of a Two-stage Feeding System in Preterm Infants
This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.
- Trial name
- NCT03728764
- Testing
- Preterm infant formula
- Where
- 4 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Pregnancy Preterm, Labor; Irregular
Multichannel EMG Diagnosing True Preterm Labor
We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions.
- Conditions
- Pregnancy Preterm, Labor; Irregular, Preterm Labor
- Trial name
- PTL (NCT03785795)
- Testing
- Uncertain diagnosis of true labor
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- PreTeL, Inc
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
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 Delivery
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1.
- Trial name
- 17PinPROM (NCT01119963)
- Testing
- 17-alpha-hydroxy-progesterone caproate, Makena®
- Where
- 15 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Oxygen Titration in Preterm Infants to Manage Lung Disease
IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood…
- Trial name
- NCT02074774
- Testing
- IntellO2, Manual control
- Where
- 2 sites in United Kingdom
- Volunteers
- 36 people
- Sponsor
- Vapotherm, Inc.
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