Clinical trials: Newborn Infant
Persistent Pulmonary Hypertension of the Newborn
Persistent Pulmonary Hypertension of the Newborn
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the…
- Trial name
- FUTURE 4 (NCT01389856)
- Testing
- Bosentan
- Volunteers
- 23 people
- Sponsor
- Actelion
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Pain
Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.
Study Population: Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery with CPB. The use of methadone to provide analgesia may be increasing due to advantages compared to other commonly used…
- Trial name
- NCT01094522
- Testing
- Methadone, Morphine
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Stanford University
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
Cystic Fibrosis
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF)…
- Trial name
- NCT03633526
- Testing
- VX-659/TEZ/IVA, IVA
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Breast Feeding
Newborn Feeding and Infant Phenotype
Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.
- Trial name
- NCT02033005
- Where
- United Kingdom
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
- Trial name
- NCT03625466
- Testing
- LUM/IVA
- Where
- 5 sites in Germany
- Volunteers
- 51 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hypoxic-Ischemic Encephalopathy, Brain Ischemia Hypoxia
CEUS Evaluation of Hypoxic Ischemic Injury
Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast.
- Trial name
- NCT03549520
- Testing
- Sulfur hexafluoride lipid-type A microspheres
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Ichthyosis
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
Efficacy and Safety of imsidolimab in Participants with Ichthyosis
- Trial name
- NCT04697056
- Testing
- Imsidolimab
- Where
- 7 sites in United States
- Volunteers
- 5 people
- Sponsor
- Vanda Pharmaceuticals
Cystic Fibrosis
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of…
- Trial name
- OPTIMIZE (NCT02054156)
- Testing
- azithromycin, Tobramycin solution for inhalation
- Where
- 45 sites in United States
- Volunteers
- 221 people
- Sponsor
- Bonnie Ramsey
Prematurity, Necrotizing Enterocolitis
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants.
- Trial name
- NCT01106209
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of Utah
Cystic Fibrosis
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine…
- Trial name
- NCT03924947
- Testing
- Pancrelipase
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- AbbVie
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00408317
- Testing
- Ultrase® MT20
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
- Trial name
- NCT02465450
- Testing
- JBT-101 (lenabasum)
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 85 people
- Sponsor
- Corbus Pharmaceuticals Inc.
Atopic Dermatitis (AD)
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.
- Trial name
- NCT02357940
- Testing
- Experimental Product
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
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, Motor Neuron Disease
MN4000 for Treatment of CF and MND Patients in the Home Setting
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
- Conditions
- Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment
- Trial name
- NCT03797677
- Testing
- MN 4000
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Cystic Fibrosis, Lung Infection
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second…
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- AIR-CF4 (NCT00712166)
- Testing
- AZLI 75 mg three times daily (TID)
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.
- Trial name
- TEACH (NCT02677701)
- Testing
- azithromycin, inhaled tobramycin
- Where
- 39 sites in United States
- Volunteers
- 119 people
- Sponsor
- Seattle Children's Hospital