Clinical trials: High Risk Infant
- Condition High Risk Infant
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
Infant Term Birth
Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.
- Trial name
- NCT02598817
- Testing
- Standard Infant Formula
- Where
- 5 sites in Saudi Arabia, United Arab Emirates
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Development, Glucose, High Blood
Effect of Nutritional Intervention on Metabolic Response in Infants
The purpose of this study is to determine the glucose response of complementary feeding regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
- Trial name
- NCT04483453
- Testing
- EXPL feeding regimen, CTRL feeding regimen
- Where
- Philippines
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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.
Atopic Dermatitis, Infant, Newborn
Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.
- Trial name
- MOPAD (NCT04398758)
- Testing
- SanaCutan Basiscreme
- Where
- 10 sites in Germany
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Infectopharm Arzneimittel GmbH
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- TEMPO (NCT03067714)
- Testing
- Infant formula with added synbiotics, Standard infant formula
- Where
- 59 sites in Belgium, Czechia and 11 more
- Volunteers
- 855 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Respiratory Syncytial Virus Infection
Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000).
- Trial name
- INSPIRA (NCT01107535)
- Testing
- Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.
- Where
- 4 sites in Peru
- Volunteers
- 82 people
- Sponsor
- Abbott
Bronchopulmonary Dysplasia
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
- Trial name
- NCT03631420
- Testing
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Where
- Taiwan
- Volunteers
- 9 people
- Sponsor
- Meridigen Biotech Co., Ltd.
Respiratory Syncytial Virus Infections
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the…
- Trial name
- NCT04980391
- Testing
- RSV MAT
- Where
- 35 sites in United States, Brazil and 7 more
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lysosomal Acid Lipase Deficiency
A Study to Identify and Characterize LAL-D Patients in High-risk Populations
The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.
- Trial name
- NCT02345421
- Where
- 15 sites in United States
- Volunteers
- 640 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Respiratory Morbidities of Prematurity (RMP)
Open-label Study of Inhaled RVT-1601 in Preterm Infants
Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term.
- Trial name
- NCT04007120
- Testing
- RVT-1601
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Respivant Sciences GmbH
Healthy
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
- Trial name
- NCT00480948
- Testing
- Infant formula feeding (InFat™), Control
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Neonatal Jaundice
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color…
- Trial name
- NCT05521607
- Testing
- Picterus Jaundice Pro (JP)
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- MAESTRO (NCT03062995)
- Testing
- Infant Formula with added synbiotics, Standard Infant formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nutricia Research
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and…
- Trial name
- NCT03959488
- Testing
- MEDI8897, Palivizumab
- Where
- 128 sites in United States, Austria and 24 more
- Volunteers
- 925 people
- Sponsor
- AstraZeneca
Bottle Feeding
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1…
- Trial name
- 9055A1-2000 (NCT02031003)
- Testing
- Infant formula
- Where
- 4 sites in Taiwan
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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.
Respiratory Syncytial Virus Infections
A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants
This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season.
- Trial name
- NCT06710925
- Testing
- TNM001
- Where
- 2 sites in China
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
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
Cystic Fibrosis
Cystic Fibrosis (CF) Flow Rates Study
We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.
- Trial name
- NCT00779077
- Volunteers
- 25 people
- Sponsor
- Syntara