Clinical trials: Preterm and Term Infants
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
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
Parent-Child Relations, Parents
Therapist Education and Massage for Parent Infant-Outcomes
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant…
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Trial name
- TEMPO (NCT04121897)
- Testing
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
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
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.
Infant, Premature, Premature Birth
Comparing IM vs. Vaginal Progesterone for Pre-term Birth
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm…
- Trial name
- NCT00579553
- Testing
- Intramuscular Progesterone, Vaginal Progesterone
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Low Birthweight, Pre-Term
Low-birthweight Infant Feeding Exploration
Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs).
- Trial name
- LIFE (NCT04002908)
- Where
- 3 sites in India, Malawi and 1 more
- Volunteers
- 3,188 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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