Clinical trials: Preterm Infant, open to volunteers
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
Retinopathy of Prematurity (ROP)
Safety, PK and PD of FLQ-101 in Premature Neonates
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
- Trial name
- tROPhy-1 (NCT07093255)
- Testing
- FLQ-101
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- FELIQS INC.
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal 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
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Bronchopulmonary Dysplasia
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
- Trial name
- NCT03631420
- Testing
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Where
- Taiwan
- Volunteers
- 9 people
- Sponsor
- Meridigen Biotech Co., Ltd.
Intestinal Malabsorption
Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA
To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
- Trial name
- NCT05904626
- Testing
- ELGN-2112
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Elgan Pharma Ltd.
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Premature Infant, Low Birthweight Infant
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth…
- Trial name
- NCT06212427
- Testing
- HMO supplement
- Where
- 6 sites in Austria, Germany
- Volunteers
- 188 people
- Sponsor
- Société des Produits Nestlé (SPN)
Growth
Preterm Infants Fed a Human Milk Fortifier
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
- Trial name
- NCT05551975
- Testing
- Control Product, Experimental Product 1, Experimental Product 2
- Where
- 14 sites in United States
- Volunteers
- 321 people
- Sponsor
- Abbott Nutrition
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
Preterm Infant Health, Premature Babies
Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants.
- Trial name
- NEOMOM (NCT07576972)
- Testing
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Mother's Milk is Best
Lung Ultrasound, Respiratory Distress Syndrome, Newborn
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
The ULISSES study looks at how doctors use bedside ultrasound to help treat premature babies with breathing problems caused by Respiratory Distress Syndrome (RDS).
- Trial name
- ULISSES (NCT07070167)
- Testing
- Intratracheal administration of surfactant
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Chiesi Poland Sp. z o.o.
Premature Birth
Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants.
- Trial name
- NCT06063122
- Testing
- smallTalk NICU Active
- Where
- 2 sites in United States
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- Thrive Neuromedical, LLC
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.
Mental Health Wellness 1, Preterm Birth
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth.
- Trial name
- MLI (NCT05012072)
- Testing
- The Mastery Lifestyle Intervention
- Where
- United States
- Volunteers
- 238 people
- Sponsor
- Microgen LLC
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.