Clinical trials: Preterm Babies
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
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 Infants
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium…
- Trial name
- NCT02066610
- Testing
- selenium and sodium selenate supplementation, selenium and sodium selenite supplementation, Without selenium and sodium selenate supplementation
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Abbott Nutrition
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 Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Other Preterm Infants
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.
- Trial name
- INV-CS-001 (NCT02224859)
- Testing
- HCP will place the Invictus Cranial Support Device (CSD) on the patient, human intervention
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Invictus Medical, Inc.
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
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.
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Preterm Birth
Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)
The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and…
- Trial name
- NCT01069744
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- KC BioMediX, Inc
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
Malnutrition, Infant, Enteral Feeding Intolerance
Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates
Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013.
- Trial name
- NCT06894446
- Testing
- Numeta G13%E, Compounded Parenteral Nutrition (cPN) solution
- Volunteers
- healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS
A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess…
- Trial name
- OPTI-SURF (NCT03808402)
- Where
- 29 sites in United Kingdom
- Volunteers
- 2,973 people
- Sponsor
- Chiesi UK
Infant, Premature, Neonatal Respiratory Distress
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Trial name
- MODERATION Neo (NCT05030012)
- Testing
- Automated Control, Manual Control
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vapotherm, Inc.
Retinopathy of Prematurity, Newborns
A Study to Collect Data on the Use of Eylea in Babies Born Too Early Who Have a Condition of the Eye Where Blood Vessels Grow Abnormally in the Retina (Retinopathy of Prematurity)
This is an observational study to collect data from Japanese babies with retinopathy of prematurity (ROP) who will be treated with Eylea.
- Conditions
- Retinopathy of Prematurity, Newborns, Infants
- Trial name
- NCT05705258
- Testing
- Aflibercept (Eylea, BAY86-5321)
- Where
- Japan
- Volunteers
- 75 people
- Sponsor
- Bayer
Neonatal Disorder
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper.
- Trial name
- CTOM-FIH (NCT03706976)
- Testing
- Tissue Oxygenation Monitoring
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Carag AG
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Trial name
- NCT00362609
- Testing
- pantoprazole
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Cystic Fibrosis
Safety and Efficacy of Ataluren (PTC124) for Cystic Fibrosis
In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00237380
- Testing
- Ataluren
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
Respiratory Distress Syndrome, Newborn
Infant Respiratory Interface and Accessories Evaluation Study
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
- Trial name
- NCT05719298
- Testing
- Respiratory interface
- Where
- Australia
- Volunteers
- 150 people
- Sponsor
- Fisher and Paykel Healthcare
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)