Clinical trials: Preterm Infant
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
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 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
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Non-invasive Ventilatory Support, Infant Respiratory Distress Syndrome
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
- Trial name
- NCT01861795
- Testing
- Preterm Neonates
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Takeda
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)
Infant Growth
Evaluation of Human Milk Fortifiers in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Trial name
- NCT02307760
- Testing
- Human Milk Fortifier A, Human Milk Fortifier B
- Where
- 18 sites in United States
- Volunteers
- 164 people
- Sponsor
- Abbott Nutrition
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
Infant Nutrition Disorders, Infant, Premature, Diseases
Safety During Use of Paediatric Triple Chamber Bag Formulas
The primary objective of this study was to provide daily information on the performance safety of the Ped3CB in practical therapeutic use in pediatric patients.
- Conditions
- Infant Nutrition Disorders, Infant, Premature, Diseases, Digestive System Disorders
- Trial name
- NCT01304394
- Testing
- Ped3CB
- Where
- 13 sites in Belgium, France
- Volunteers
- 161 people
- Sponsor
- Baxter Healthcare Corporation
Respiratory Tract Infection, Respiratory Syncytial Virus
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational…
- Trial name
- NCT03524118
- Testing
- Clesrovimab
- Where
- 34 sites in United States, Chile and 4 more
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Growth, Development
Preterm Infant Growth
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
- Conditions
- Growth, Development, Infant
- Trial name
- NCT01162798
- Testing
- infant formula, control infant formula
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Infant
Effect of a Mixture of New Probiotic Strains in Preterm Infants
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 \& Bifidobacterium PS10402 in premature infants from 28 weeks + 0…
- Trial name
- PREBIOMA (NCT03701906)
- Testing
- Lactobacillus PS11603 & Bifidobacterium PS10402
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
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.
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.
Other Preterm Infants
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
This is a two stage open-label, single-arm, multicenter and observational study.
- Trial name
- NCT02073071
- Testing
- Preterm infant formula per standard of care
- Where
- 10 sites in China
- Volunteers
- 139 people
- Sponsor
- Abbott Nutrition
Respiratory Distress Syndrome in Premature Infants
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions…
- Trial name
- NCT01651637
- Testing
- synthetic surfactant (CHF5633)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
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
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait