Clinical trials: Preterm Labor
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Premature Infants
Feeding Study in Premature Infants
To evaluate weight gain of preterm infants fed fortified human milk.
- Trial name
- NCT00681018
- Testing
- Liquid human milk fortifier, Powder human milk fortifier
- Where
- 14 sites in United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience
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
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.
Apnea of Prematurity
Clinical Study of Caffeine for Apnea of Prematurity
The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
- Trial name
- NCT01408173
- Testing
- NPC-11 for intravenous or oral administration.
- Where
- 3 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Nobelpharma
Infant, Extremely Premature, Length of Stay
Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e.
- Conditions
- Infant, Extremely Premature, Length of Stay, Feeding
- Trial name
- NCT01158391
- Testing
- NTrainer® Intervention, Control Intervention
- Where
- 5 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- KC BioMediX, Inc
Respiratory Syncytial Virus (RSV)
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16…
- Trial name
- NCT07363837
- Testing
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
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
Intra-amniotic Infection
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic Membranes
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic…
- Trial name
- IAI (NCT00700219)
- Where
- 21 sites in United States
- Volunteers
- 900 people
- Sponsor
- ProteoGenix, Inc.
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
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
Obstetric Labour, Premature
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in…
- Trial name
- NCT01867996
- Testing
- Retosiban, EFZ 600 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bronchopulmonary Dysplasia
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing…
- Trial name
- NCT01828957
- Testing
- Pneumostem®, Normal Saline
- Where
- 2 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Medipost Co Ltd.
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
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
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
Prematurity
Early DHA Supplementation in Very Low Birth Weight Infants
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
- Trial name
- NCT03192839
- Testing
- Low dose PUFA, High dose PUFA
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mead Johnson Nutrition
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 Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season.
- Conditions
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- Trial name
- NCT00316264
- Testing
- Motavizumab, palivizumab, Palivizumab, motavizumab, Motavizumab
- Where
- 19 sites in Australia, Chile and 1 more
- Volunteers
- 260 people
- Sponsor
- MedImmune LLC