Clinical trials: Newborn Infant
Cystic Fibrosis
Tiotropium Bromide in Cystic Fibrosis
To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive…
- Trial name
- NCT01179347
- Testing
- tiotropium Respimat® inhaler
- Where
- 99 sites in United States, Australia and 18 more
- Volunteers
- 464 people
- Sponsor
- Boehringer Ingelheim
Retinopathy of Prematurity, Neonatal Cholestasis
The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency.
- Trial name
- NCT01875510
- Testing
- Fish-oil emulsions, soybean-oil emulsion
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Dr. Sami Ulus Children's Hospital
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Cystic Fibrosis
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
- Trial name
- KONTINUE (NCT01707290)
- Testing
- Ivacaftor
- Where
- 38 sites in United States, Belgium and 2 more
- Volunteers
- 125 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Family Planning, Contraception
Linking Inter-professional Newborn and Contraception Care
Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes and affect nearly one third of women in the U.S.
- Conditions
- Family Planning, Contraception, PostPartum
- Trial name
- LINCC (NCT04092530)
- Testing
- LINCC intervention - enable co-schedule feature
- Where
- 5 sites in United States
- Volunteers
- 2,518 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Respiratory Insufficiency, Infant, Newborn, Disease
Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants
This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with…
- Trial name
- NCT02518230
- Testing
- Neurally Adjusted Ventilatory Assist, Synchronized Interm. Mandatory Assist
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Mercy Hospital Kansas City
Cystic Fibrosis
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR…
- Trial name
- NCT01946412
- Testing
- Ivacaftor
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 33 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Neonatal Abstinence Syndrome
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero.
- Trial name
- NCT02851303
- Testing
- Morphine, Methadone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of New Mexico
Cystic Fibrosis
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.
- Trial name
- NCT02129803
- Testing
- High-Flow, 20 LPM (via Optiflow cannula), Low FLow, 5 LPM (via Optiflow cannula)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Virginia Commonwealth University
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Mucociliary Clearance Defect
Researching the Effects of Airway Clearance Therapies in Cystic Fibrosis
This is a pilot study investigating the effectiveness and clinical efficacy of airway clearance therapy (ACT) in cystic fibrosis (CF).
- Trial name
- REACT-CF (NCT03078127)
- Testing
- Baseline (Huff-Cough alone), Oscillatory Positive Expiatory Pressure Device, Whole-Body Vibration Platform
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of North Carolina, Chapel Hill
Bone Marrow Failure Syndrome, Thalassemia
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum…
- Conditions
- Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia
- Trial name
- NCT03513328
- Testing
- Thiotepa--single daily dose, Thiotepa--escalated dose
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
Biliary Atresia
Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to determine the feasibility, acceptability, tolerability and safety profile of IVIG treatment administered to infants after…
- Trial name
- PRIME (NCT01854827)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Congenital Heart Disease
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD.
- Trial name
- HEARTPrep (NCT05129631)
- Testing
- HEARTPrep
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nemours Children's Clinic
Cystic Fibrosis
Self-dispersing Liquids as Aerosol Drug Carriers
Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly…
- Trial name
- NCT00628134
- Testing
- calfactant, isotonic saline
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Pittsburgh
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Genetic Diseases, Genetic Syndrome
Perinatal Precision Medicine
This study will seek to determine if rapid genomic sequencing improves outcomes for acutely ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective, randomized, blinded study to either rapid…
- Conditions
- Genetic Diseases, Genetic Syndrome, Mendelian Disorders
- Trial name
- NSIGHT2 (NCT03211039)
- Testing
- Genomic sequencing and molecular diagnostic results, if any.
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
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
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
- Trial name
- TOLSURFPilot (NCT00569530)
- Testing
- Infasurf (ONY Inc.)
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Roberta Ballard
Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis
Safety Study of Gene Modified Donor T Cell Infusion After Stem Cell Transplant for Non-Malignant Diseases
The purpose of this study is to determine a safe dose of BPX-501 gene modified T cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of Rimiducid (AP1903) on day 7 to prevent GVHD.
- Conditions
- Primary Immune Deficiency Disorders, Hemophagocytic Lymphohistiocytosis, Inherited Bone Marrow Failure Syndrome, Hemoglobinopathies
- Trial name
- NCT02231710
- Testing
- BPX-501 and Rimiducid
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Bellicum Pharmaceuticals