Clinical trials: Pregnancy Preterm
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Obstetric Labour, Premature
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor.
- Trial name
- NCT00404768
- Testing
- GSK221149A
- Where
- 57 sites in United States, Argentina and 9 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
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.
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.
Intraventricular Brain Hemorrhage
Detection and Quantification of Neonatal Intraventricular Hemorrhage
Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants - both preterm and term.
- Trial name
- DQNIH (NCT01899651)
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Electrical Geodesics, Inc.
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
Fetal Membranes, Premature Rupture
PROMComplete for Determination of Rupture of Fetal Membranes
Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased…
- Trial name
- (PROMComplete (NCT02369601)
- Testing
- non- intervention study
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Pro-Lab Diagnostics
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
Respiratory Syncytial Virus Infections
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections…
- Trial name
- NCT00384462
- Where
- 59 sites in United States
- Volunteers
- 346 people
- Sponsor
- MedImmune LLC
Prematurity, Vascular Aging
Exclusive Human-milk in Preterm NEOnates and Early VASCular Aging Risk Factors (NEOVASC)
Early vascular aging has its origins in fetal and neonatal life. The NEOVASC clinical trial aims to determine the effects of an exclusive human milk diet in extremely preterm infants on long-term cardiovascular health.
- Trial name
- NEOVASC (NCT04413994)
- Testing
- Humavant
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Prolacta Bioscience
Pre Term Labor, Multiple Pregnancy
Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.
- Trial name
- NCT01360905
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Monica Healthcare Ltd
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, Preterm Birth
fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Among women with a twin pregnancy, currently enrolled in a study in which they are receiving weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal fibronectin (fFN) and salivary estriol (E3 )…
- Trial name
- NCT00156000
- Testing
- Fetal Fibronectin, Salivary Estriol
- Where
- 2 sites in United States
- Sponsor
- Obstetrix Medical Group
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
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus Hospitalizations
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.
- Trial name
- SENTINEL1 (NCT02273882)
- Where
- 44 sites in United States
- Volunteers
- 497 people
- Sponsor
- AstraZeneca
Preterm Delivery
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening…
- Trial name
- NCT01009723
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Esoterix Genetic Laboratories, LLC
Necrotizing Enterocolitis
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Trial name
- NCT00977912
- Testing
- Probiotic supplementation
- Where
- 3 sites in South Africa
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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