Clinical trials: Infant
Cystic Fibrosis (CF)
: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva.
- Trial name
- NCT03445793
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.
- Trial name
- NCT02694393
- Testing
- sodium nitrite
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Schmidhofer, Mark, MD
Haemophilus Influenzae Type b, Neisseria Meningitidis
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to…
- Trial name
- NCT00129129
- Testing
- GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine, ActHIB, Pediarix
- Where
- 27 sites in United States
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.
- Trial name
- NCT00569192
- Testing
- 0.135mg MAP0010, 0.25mg MAP0010
- Volunteers
- 360 people
- Sponsor
- Allergan
Enterocolitis, Necrotizing, Premature Infant
NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful…
- Trial name
- NCT03963011
- Testing
- Bowel Ultrasound
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Children's Mercy Hospital Kansas City
Diarrhea, Diarrhea Rotavirus
Phase III Study of Liquid Formulation of ROTAVIN
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second…
- Trial name
- NCT03703336
- Testing
- ROTAVIN (liquid formulation), ROTAVIN-M1 (frozen formulation)
- Where
- 2 sites in Vietnam
- Volunteers
- 825 people, healthy volunteers welcome
- Sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam
Respiratory Distress Syndrome in Premature Infant
Physiological Changes With High-Flow Nasal Cannula
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
- Trial name
- NCT03700606
- Testing
- High flow nasal cannula, Nasal CPAP
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Sharp HealthCare
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the…
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- Trial name
- NCT01427712
- Testing
- Pancrelipase
- Where
- 21 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Mylan Inc.
Meningococcal Infections
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared…
- Trial name
- NCT03547271
- Testing
- MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine
- Where
- 33 sites in Czechia, Finland and 5 more
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Spinal Muscular Atrophy
Pre-Symptomatic Study of Intravenous Onasemnogene Abeparvovec-xioi in Spinal Muscular Atrophy (SMA) for Patients With Multiple Copies of SMN2
To evaluate the safety and efficacy of intravenous onasemnogene abeparvovec-xioi in pre-symptomatic patients with SMA and 2 or 3 copies SMN2
- Trial name
- SPR1NT (NCT03505099)
- Testing
- onasemnogene abeparvovec-xioi
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Gene Therapies
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Schistosomiasis
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni.
- Trial name
- NCT02806232
- Testing
- Biltricide (racemate praziquantel) oral tablets, Racemate Praziquantel ODT, Levo Praziquantel ODT
- Where
- Germany
- Volunteers
- 444 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Cystic Fibrosis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
- Trial name
- NCT02347657
- Testing
- VX-661 Plus Ivacaftor Combination, Ivacaftor
- Where
- 74 sites in United States, Canada and 10 more
- Volunteers
- 510 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Fever
Acetaminophen Before Vaccines for Infants Study (AVIS)
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.
- Trial name
- NCT00325819
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 374 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
Semaglutide in CFRD
This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).
- Trial name
- NCT05788965
- Testing
- Semaglutide
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Minnesota
Pneumococcal Infections
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization
This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.
- Trial name
- NCT00508742
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 5 sites in Israel
- Volunteers
- 1,866 people, healthy volunteers welcome
- Sponsor
- Pfizer
Food Protein-Induced Enterocolitis Syndrome, Allergies
Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
The aim of this study is to validate a blood test that can identify safe foods for food protein-induced enterocolitis syndrome (FPIES).
- Conditions
- Food Protein-Induced Enterocolitis Syndrome, Allergies, Pediatric Disorder
- Trial name
- NCT04644783
- Testing
- Blood test assay
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Michigan
Infant of Diabetic Mother, Oxidative Stress
NAC +taVNS in IDM Who Are Poor Oral Feeders
Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired…
- Conditions
- Infant of Diabetic Mother, Oxidative Stress, Vagus Nerve Stimulation, Feeding Disorders
- Trial name
- NCT04632069
- Testing
- N acetyl cysteine + vagus nerve stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina