Clinical trials: Premature
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Syncytial Virus
Respiratory Events Among Premature Infants
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.
- Trial name
- NCT00889070
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- MedImmune LLC
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
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
129Xe MRI in Pediatric Population With BPD
Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder.
- Trial name
- NCT04035629
- Testing
- MagniXene, hyperpolarized 129Xe MRI
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Xemed LLC
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.
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
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
Nosocomial Infections
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
- Trial name
- NCT00854633
- Testing
- Talactoferrin
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Agennix
Preterm Birth, Low Birth Weight <2500 Grams
Reducing Preterm Births in Underserved Pregnant Women
Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex.
- Conditions
- Preterm Birth, Low Birth Weight <2500 Grams, Verylow Birthweight <1500 Grams
- Trial name
- NCT01344616
- Testing
- lifestyle support
- Where
- United States
- Volunteers
- 482 people, healthy volunteers welcome
- Sponsor
- PHCC LP
Retinopathy of Prematurity
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP).
- Trial name
- BUTTERFLEYE (NCT04101721)
- Testing
- aflibercept, laser photocoagulation
- Where
- 52 sites in United States, Bulgaria and 11 more
- Volunteers
- 127 people
- Sponsor
- Regeneron Pharmaceuticals
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
Retinopathy of Prematurity
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease…
- Trial name
- NCT04985448
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Chengdu Kanghong 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.
RSV Immunization, Healthy Volunteer
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection…
- Trial name
- NCT05437510
- Testing
- Nirsevimab
- Where
- 240 sites in France, Germany and 1 more
- Volunteers
- 8,057 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Retinopathy of Prematurity (ROP)
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe…
- Trial name
- FIREFLEYE (NCT04004208)
- Testing
- Eylea (Aflibercept, BAY86-5321), Laser photocoagulation
- Where
- 90 sites in Argentina, Austria and 25 more
- Volunteers
- 113 people
- Sponsor
- Bayer
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Respiratory Syncytial Virus Infection
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants.
- Trial name
- CLEVER (NCT04767373)
- Testing
- Clesrovimab
- Where
- 217 sites in United States, Argentina and 22 more
- Volunteers
- 3,632 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC