Clinical trials: Neonatal Infections
CMV, Congenital Cmv
Cytomegalovirus Shedding Characteristics in Pregnant Women
The cCHIPS study is a feasibility study for larger scale multi-centre studies and is designed as a single-centre observational cohort, longitudinal, natural history study.
- Conditions
- CMV, Congenital Cmv, Maternal Infections Affecting Fetus or Newborn, Shedding Virus
- Trial name
- cCHIPS (NCT04021628)
- Testing
- No intervention- not applicable
- Where
- United Kingdom
- Volunteers
- 160 people
- Sponsor
- St George's, University of London
Sickle Cell Disease (SCD)
Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
The purpose of this study was to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 2 to <18 years with a history of Vaso-Occlusive Crisis (VOC) with or without…
- Trial name
- NCT03474965
- Testing
- Crizanlizumab
- Where
- 35 sites in United States, Belgium and 12 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
Heart Defects, Congenital, Hyperglycemia
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk…
- Trial name
- SPECS (NCT00443599)
- Testing
- Insulin, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 989 people
- Sponsor
- Boston Children's Hospital
Pseudomonas Aeruginosa Infection
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections.
- Trial name
- NCT01315678
- Testing
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Where
- 62 sites in Austria, Belgium and 16 more
- Volunteers
- 302 people
- Sponsor
- Insmed Incorporated
Chronic Granulomatous Disease, Crohn'S-like IBD
Infliximab to Treat Crohn'S-like Inflammatory Bowel Disease in Chronic Granulomatous Disease
This study will determine if the drug infliximab is safe for treating inflammatory bowel disease (IBD) in patients with chronic granulomatous disease (CGD).
- Conditions
- Chronic Granulomatous Disease, Crohn'S-like IBD, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT00325078
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis, Burkholderia Cepacia Infection
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of cystic fibrosis patient.
- Trial name
- NCT02212587
- Testing
- TOBI
- Where
- 2 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Unity Health Toronto
Chronic Myeloproliferative Disorders, Leukemia
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00134004
- Testing
- cyclophosphamide, fludarabine phosphate, mycophenolate mofetil
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Cystic Fibrosis
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
This is a Phase 2 study with primary objective of looking whether YPT-01 phage therapy reduces sputum bacterial load in cystic fibrosis subjects with Pseudomonas aeruginosa.
- Trial name
- NCT04684641
- Testing
- Standard Dose YPT-01
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Yale University
Cancer
Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant
RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood.
- Trial name
- NCT00617929
- Testing
- anti-thymocyte globulin, rituximab, clofarabine
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Bacterial Infections
Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.
- Trial name
- NCT02527681
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 15 people
- Sponsor
- Basilea Pharmaceutica
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa Infection
- Trial name
- NCT02421120
- Testing
- Ceftolozane/Tazobactam
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Joseph L. Kuti, PharmD
Herpes Simplex Virus, Neonatal Sepsis
A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Acyclovir is a drug used to treat herpes simplex virus (HSV) infections in babies. Appropriate dosing of acyclovir is known for adults and children but acyclovir has not been adequately studied in full-term or premature neonates.
- Trial name
- NCT00942084
- Testing
- Acyclovir
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Phillip Brian Smith
Maternal Sepsis, Neonatal Sepsis
Smart Discharges for Mom & Baby
This study aims to build a predictive algorithm that identifies mother-newborn dyads most at risk of death or complications in the 6 weeks after birth.
- Trial name
- NCT05730387
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 7,182 people
- Sponsor
- University of British Columbia
Sepsis
Impact of Heart Rate Characteristics Monitoring in Neonates
Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.
- Trial name
- HeRO (NCT00307333)
- Testing
- HeRO heart rate characteristics monitor
- Where
- 8 sites in United States
- Volunteers
- 3,003 people
- Sponsor
- University of Virginia
Chronic Myeloproliferative Disorders, Leukemia
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic Cancer
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor stem cell helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Myelodysplastic Syndromes
- Trial name
- NCT00003816
- Testing
- anti-thymocyte globulin, busulfan, carboplatin
- Where
- United States
- Volunteers
- 361 people
- Sponsor
- Roswell Park Cancer Institute
Hepatitis B
Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs…
- Trial name
- NCT00456625
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Diphtheria
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
- Trial name
- NCT02757950
- Testing
- Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
- Where
- Brazil
- Volunteers
- 2,462 people
- Sponsor
- GlaxoSmithKline
Leukemia, Lymphoma
AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Trial name
- NCT00547196
- Testing
- filgrastim, Busulfan, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- City of Hope Medical Center
Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission
Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion
Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality.
- Conditions
- Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes, Chronic Myeloid Leukemia
- Trial name
- HAPLOTAB (NCT05236764)
- Testing
- CliniMACS
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine