Clinical trials: Preterm Delivery
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
Respiratory Distress Syndrome In Premature Infants
Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates
The purpose of this study is to determine the safety and effectiveness of the Babylog VN500 in high frequency oscillatory ventilation (HFOV) mode as a method for treating very low birth weight (VLBW) neonates requiring invasive…
- Trial name
- NCT02445040
- Testing
- Babylog VN500 in HFOV Mode
- Where
- 14 sites in United States
- Volunteers
- 225 people
- Sponsor
- Draeger Medical Systems, Inc.
Preterm Infants
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
- Trial name
- NCT01373073
- Testing
- Experimental human milk fortifier, Control human milk fortifier
- Where
- 15 sites in United States
- Volunteers
- 147 people
- Sponsor
- Abbott Nutrition
Bronchopulmonary Dysplasia
Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.
- Trial name
- NCT01297205
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Medipost Co Ltd.
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.
Respiratory Distress Syndrome
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks…
- Trial name
- NCT02074059
- Testing
- Lucinactant for Inhalation, nCPAP alone
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Windtree Therapeutics
Bacterial Infections
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
- Trial name
- NCT02688790
- Testing
- Dalbavancin
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- AbbVie
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
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)
Preeclampsia (PE)
Non-Invasive Preeclampsia Screening and Biobank
Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
- Trial name
- NCT06643741
- Where
- 21 sites in United States
- Volunteers
- 6,550 people, healthy volunteers welcome
- Sponsor
- Sequenom, Inc.
Ductus Arteriosus, Patent
Paracetamol in Patent Ductus Arteriosus
The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT02422966
- Testing
- Paracetamol, Ibuprofen
- Where
- 5 sites in Italy
- Volunteers
- 110 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Intestinal Malabsorption
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.
- Trial name
- NCT05670951
- Testing
- ELGN-2112
- Where
- Israel
- Volunteers
- 360 people
- Sponsor
- Elgan Pharma Ltd.
Preterm Milk, Term Milk
Pre/Term Milk Profiling
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
- Trial name
- NCT02052245
- Where
- Switzerland
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Respiratory Distress Syndrome, Newborn
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies…
- Trial name
- Curpap (NCT00501982)
- Testing
- Poractant alfa (Curosurf®)
- Where
- 5 sites in Czechia, France and 3 more
- Volunteers
- 208 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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
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.
RDS of Prematurity, Preterm Birth
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT06917326
- Testing
- Monitoring
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Neola Medical AB
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
- Trial name
- NCT00659243
- Testing
- rhBSSL
- Where
- 8 sites in France, Italy
- Volunteers
- 32 people
- Sponsor
- Swedish Orphan Biovitrum
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
Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who…
- Trial name
- NCT01146990
- Testing
- ASQ-3, Bayley III, Neurologic exam
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 245 people
- Sponsor
- AMAG Pharmaceuticals, Inc.