Clinical trials: Infant ALL
Infantile Spasms
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record.
- Trial name
- NCT02954887
- Testing
- GWP42003-P
- Where
- 7 sites in United States, Poland
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
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
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase.
- Trial name
- NCT02279498
- Testing
- Liprotamase, porcine (pig) PERT
- Where
- 54 sites in United States, Canada and 5 more
- Volunteers
- 128 people
- Sponsor
- Anthera Pharmaceuticals
Japanese Encephalitis
Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and…
- Trial name
- JEV03 (NCT00463684)
- Testing
- Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine, Live, attenuated measles vaccine
- Where
- 3 sites in Sri Lanka
- Volunteers
- 278 people, healthy volunteers welcome
- Sponsor
- PATH
Poliomyelitis
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
- Trial name
- NCT00937404
- Testing
- Poliorix
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Congenital Diaphragmatic Hernia
Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality and need for life-saving interventions such as extracorporeal membrane oxygenation (ECMO), nitric oxide, and vasopressor…
- Trial name
- DING (NCT03314233)
- Testing
- DING
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Children's Hospital of Philadelphia
Eczema, Egg Allergy
Promoting Tolerance to Peanut in High-Risk Children
This study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema.
- Conditions
- Eczema, Egg Allergy, Food Allergy
- Trial name
- LEAP (NCT00329784)
- Testing
- Peanut Consumption Group
- Where
- United Kingdom
- Volunteers
- 640 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following…
- Trial name
- NCT02207816
- Testing
- Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
- Where
- 3 sites in Burkina Faso, Kenya and 1 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- TIS (NCT01270347)
- Testing
- MP-376 (Levofloxacin Solution for Inhalation), TIS (Tobramycin Inhalation Solution)
- Where
- 130 sites in United States, France and 4 more
- Volunteers
- 282 people
- Sponsor
- Amgen
Muscular Atrophy, Spinal
A Study of Risdiplam in Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy
A global study of oral risdiplam in pre-symptomatic participants with spinal muscular atrophy (SMA).
- Trial name
- Rainbowfish (NCT03779334)
- Testing
- Risdiplam
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Meningococcal Infection
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
- Trial name
- NCT01340898
- Testing
- Meningococcal vaccine GSK 134612, SynflorixTM, Infanrix-IPV/HiberixTM
- Where
- 2 sites in Lebanon, Mexico
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic…
- Trial name
- SNO-1 (NCT01746784)
- Testing
- N6022, Normal saline
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- Nivalis Therapeutics, Inc.
Cystic Fibrosis
Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and the G5 Flimm-Fighter in Patients With CF
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and the G5 Flimm-Fighter) for airway clearance (AC) in CF patients with mild…
- Trial name
- NCT02423447
- Testing
- Electro-Flo Intervention, G5 Intervention
- Volunteers
- 25 people
- Sponsor
- Stanford University
Hypophosphatasia
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).
- Trial name
- NCT01205152
- Testing
- asfotase alfa
- Where
- 8 sites in United States, United Arab Emirates and 1 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Infant, Newborn, Infant, Moderate Preterm
Incubator Weaning of Moderately Preterm Infants
The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.
- Trial name
- NCT02160002
- Testing
- Weaning from an incubator at a lower weight (1600 grams), Weaning from an incubator at a higher weight (1800 grams)
- Where
- 18 sites in United States
- Volunteers
- 366 people
- Sponsor
- NICHD Neonatal Research Network
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
Infant, Premature, Diseases, Infant, Small for Gestational Age
Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants
In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3)…
- Trial name
- NCT02372136
- Testing
- Individualized Nutrition, Optimized nutrition
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Pediatric Glaucoma, Elevated IOP in Pediatric Patients
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma…
- Conditions
- Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients
- Trial name
- NCT01652664
- Testing
- Travoprost 0.004% PQ ophthalmic solution, Timolol, 0.5% or 0.25% ophthalmic solution, Travoprost Vehicle
- Volunteers
- 184 people
- Sponsor
- Alcon Research
Vaccines, Combined, Hexavalent Vaccine
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at ~11 to 13 months of age in healthy participants who were previously vaccinated with a…
- Trial name
- NCT05289271
- Testing
- Vaxelis™
- Where
- 13 sites in Germany, Italy and 1 more
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Family Relationship, Stress
Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Family Relationship, Stress, Breastfeeding, Bottle Feeding
- Trial name
- NCT02901665
- Testing
- FCC intervention
- Where
- 2 sites in United States
- Volunteers
- 191 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago