Clinical trials: High-risk Infants
Malaria
Kilimanjaro IPTi Drug Options Trial
Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they…
- Trial name
- NCT00158574
- Testing
- sulphadoxine-pyrimethamine, mefloquine, Chlorproguanil-dapsone
- Where
- Tanzania
- Volunteers
- 2,419 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Hypertension
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
- Trial name
- NCT01078376
- Testing
- Azilsartan medoxomil (TAK-491)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Takeda
Atopic Dermatitis (AD), Autoantibody
Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis
Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as "self-reactive antibodies" or…
- Conditions
- Atopic Dermatitis (AD), Autoantibody, Auto-Immunity, Microbiome, Human
- Trial name
- DIANA (NCT07316465)
- Testing
- Development of atopic dermatitis with/without IgE autoantibodies
- Where
- Belgium
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
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
Rotavirus Infections
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
- Trial name
- NCT03483116
- Testing
- RV3-BB
- Where
- Malawi
- Volunteers
- 711 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
Postnatal Growth Restriction
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks'…
- Trial name
- NCT05403684
- Testing
- High-volume breastmilk
- Where
- Zambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Infant Malnutrition, Malnutrition in Pregnancy
Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi.
- Trial name
- iLiNS-DYAD-M (NCT01239693)
- Testing
- IFA, MMN, LNS
- Where
- Malawi
- Volunteers
- 1,391 people, healthy volunteers welcome
- Sponsor
- Tampere University
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Spinal Muscular Atrophy, Neonatal Hyperbilirubinemia
Establishing Novel Detection Techniques for Various Genetic-Related Diseases by Applying DHPLC Platform.
In this, here we want to present a new method for analysis variation in gene copy number for patients and carriers of SMA. This is a relative quantitation method and, therefore, relies on the inclusion of one or more internal…
- Conditions
- Spinal Muscular Atrophy, Neonatal Hyperbilirubinemia, Colon Cancer
- Trial name
- NCT00154960
- Where
- Taiwan
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Pregnancy, Postpartum
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior.
- Conditions
- Pregnancy, Postpartum, Childbirth, Health Status
- Trial name
- HIIT MAMA (NCT05009433)
- Testing
- High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women, Standard obstetric care with extended education on healthy lifestyle
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Gdansk University of Physical Education and Sport
Polio
Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life
Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single…
- Trial name
- IPV005 (NCT02111135)
- Testing
- b-OPV, m-OPV2, m-IPV HD
- Where
- Panama
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Vaxtrials S.A.
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
Development Delay, Motor Skills Disorders
Effect of a Telerehabilitation-Supported, Family-Centered Early Intervention Program on Neurodevelopmental and Parental Outcomes in Infants at Mild-to-Moderate Risk
The goal of this pilot randomized controlled trial is to learn whether a family-centered early intervention program, delivered remotely to parents and carried out at home, can support the development of infants who were treated…
- Conditions
- Development Delay, Motor Skills Disorders, Neurodevelomental Disorders, High Risk Infant
- Trial name
- NCT07878819
- Testing
- Remote Family-Centered Early Intervention Program, Standard Information and Routine Follow-up
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bengisu Boz Gürboğa
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
Atopic Dermatitis, Eczema
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
There is a lack of prospective scientific data on the regular use of moisturizers in patients at risk of developing atopic dermatitis.
- Conditions
- Atopic Dermatitis, Eczema, Asthma, Food Allergies
- Trial name
- NCT01577628
- Testing
- Lipikar Balm AP
- Where
- 4 sites in United States, Canada
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma
- Trial name
- NCT06333899
- Testing
- Lorlatinib, Lorlatinib with chemotherapy1, Lorlatinib with chemotherapy 2
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Cystic Fibrosis
Bone Microarchitecture in Young Cystic Fibrosis Patients
Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age.
- Trial name
- NCT01788267
- Testing
- scan examination HR-pQCT
- Where
- France
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Cystic Fibrosis, Sensorineural Hearing Loss
Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis
The purpose of this study is to find out whether the High Frequency Digit Triplet test can be used to screen patients with cystic fibrosis for hearing loss in conditions of health and pulmonary exacerbation.
- Trial name
- 3D-CF (NCT02252601)
- Testing
- HFDT test, Pure tone Audiogram
- Where
- 3 sites in United Kingdom
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- University of Nottingham
Respiratory Insufficiency
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing.
- Trial name
- NCT01531465
- Testing
- Pulmonary Function Testing & esophageal pressure monitoring, Pulmonary function testing and esophageal pressure
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
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)