Clinical trials: Newborn Infant
Cystic Fibrosis
Electro Flo 5000 and Vest Therapy
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 VEST therapy) for airway clearance (AC) in CF patients with mild to…
- Trial name
- EF/Vest (NCT02277626)
- Testing
- Electro Flo 5000, Incourage Vest System
- Volunteers
- 15 people
- Sponsor
- Stanford University
Cystic Fibrosis
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
- Trial name
- (HOPE-1) (NCT03229252)
- Testing
- SPX-101
- Where
- 25 sites in Canada, France and 3 more
- Volunteers
- 91 people
- Sponsor
- Spyryx Biosciences, Inc.
Cystic Fibrosis
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of…
- Trial name
- NCT02730208
- Testing
- Tezacaftor/Ivacaftor, Ivacaftor
- Where
- 9 sites in Australia
- Volunteers
- 41 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Poor Feeding, Infant Development
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke.
- Conditions
- Poor Feeding, Infant Development, Vagus Nerve Stimulation
- Trial name
- NCT04643808
- Testing
- transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Medical University of South Carolina
Patent Ductus Arteriosus
Timing of PDA Closure and Respiratory Outcome in Premature Infants
The investigators propose the present study with the following aims: to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen…
- Trial name
- NCT00802685
- Testing
- Early ibuprofen
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of Miami
Opioid-Related Disorders, NAS
MOms in REcovery (MORE) Study: Defining Optimal Care
Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with…
- Conditions
- Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
- Trial name
- MORE (NCT04251208)
- Testing
- Observational Study
- Where
- 10 sites in United States
- Volunteers
- 2,510 people
- Sponsor
- Trustees of Dartmouth College
Atopic Dermatitis
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based…
- Trial name
- NCT00124709
- Testing
- Pimecrolimus, Corticosteroid
- Where
- 36 sites in United States
- Volunteers
- 1,091 people
- Sponsor
- Novartis Pharmaceuticals
Premature Birth, Neonatal Hypoxic Conditions
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
- Trial name
- Vanilla (NCT02630147)
- Testing
- Vanilla scent
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Université de Sherbrooke
Depression, Cystic Fibrosis
Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
The purpose of this study is to determine whether bright light phototherapy can improve depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent effects on quality of life and illness recovery.
- Trial name
- PHOTO (NCT01822197)
- Testing
- Phototherapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nationwide Children's Hospital
Cystic Fibrosis
Study of Ataluren (PTC124) in Cystic Fibrosis
The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study…
- Trial name
- NCT02107859
- Testing
- Ataluren
- Where
- 17 sites in United States, Belgium and 5 more
- Volunteers
- 61 people
- Sponsor
- PTC Therapeutics
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
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke University
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one…
- Trial name
- Fenaki (NCT02620761)
- Testing
- Fenoldopam, 0.9%NS
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Trial name
- NCT00362609
- Testing
- pantoprazole
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
Mucopolysaccharidosis VI, Maroteaux-Lamy Syndrome
A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI
The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.
- Trial name
- NCT00299000
- Testing
- Naglazyme
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 4 people
- Sponsor
- BioMarin Pharmaceutical
Cystic Fibrosis
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the…
- Trial name
- NCT02508207
- Testing
- Tezacaftor/Ivacaftor, Ivacaftor
- Where
- 7 sites in United States
- Volunteers
- 34 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy, Cystic Fibrosis (CF)
MRI for Non-Invasive Imaging in Neonates and Children
The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent.
- Conditions
- Healthy, Cystic Fibrosis (CF), Asthma, Bronchopulmonary Dysplasia (BPD)
- Trial name
- NCT02163681
- Testing
- Hyperpolarized Helium-3 MRI of the chest
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Virginia