Clinical trials: Preterm and Term Infants
- Condition Preterm and Term Infants
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Pre-term Infant
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without…
- Trial name
- NCT04639518
- Testing
- Preterm formulas with HMO, Preterm formulas without HMO
- Where
- 4 sites in Germany, Poland and 1 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
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
Lower Respiratory Tract Infection
Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China
- Trial name
- CHIMES (NCT05110261)
- Testing
- Nirsevimab
- Where
- 30 sites in China
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Preterm Birth, Healthy
A Study Evaluating Sleep, Stress and Infant Nutrition Using a Chatbot
20 parents with healthy preterm infants (born at <37 weeks of gestation), age 0-6 months and discharged from the hospital at time of enrollment and 20 parents with healthy full-term infants (born at ≥37 weeks of gestation), age…
- Trial name
- NCT03630679
- Where
- Singapore
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
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
Gut Microbiota Modulation
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM…
- Trial name
- NCT07882537
- Testing
- Enterolactis Baby® drops
- Where
- Italy
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Personal Satisfaction
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
- Trial name
- InFat_002 (NCT00874068)
- Testing
- InFat™ based infant formula, Standard vegetable oil based infant formula
- Where
- Israel
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Respiratory Syncytial Virus Infections
A Study of TNM001 in Chinese Healthy Preterm and Term Infants
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants.
- Trial name
- NCT05630573
- Testing
- TNM001
- Where
- 6 sites in China
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
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 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)
Haemophilus Influenzae Type b, Neisseria Meningitidis
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta)…
- Trial name
- NCT00586612
- Testing
- Menitorix™, Infanrix™ penta, Prevenar™
- Where
- 8 sites in Spain
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline