Clinical trials: Newborn Infant
Pancreatic Insufficiency, Cystic Fibrosis
Proton Pump Inhibitors (PPI) and Fat Absorption in Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
This is a clinical trial with a cross over design investigating the effect of the proton pump inhibitor omeprazole on fat malabsorption in subjects with cystic fibrosis and pancreatic insufficiency.
- Trial name
- NCT03551691
- Testing
- Omeprazole 20mg Capsule
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospital of Philadelphia
Cystic Fibrosis
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
The investigators know that adherence to medications in children with cystic fibrosis (CF) is poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and their parents.
- Trial name
- NCT02301377
- Testing
- Spiro PD personal spirometer
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Michigan
Necrotizing Enterocolitis of Newborn, Bowel Ischemic
CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis
There is no bedside imaging technique that can quantify dynamic bowel perfusion with high soft tissue contrast and sensitivity in necrotizing enterocolitis (NEC).
- Trial name
- NCT03549507
- Testing
- Sulfur hexafluoride lipid-type A microspheres
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Improving Outcomes in Neonatal Abstinence Syndrome
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied.
- Trial name
- NCT01958476
- Testing
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Where
- 8 sites in United States
- Volunteers
- 117 people
- Sponsor
- Tufts Medical Center
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
Cystic Fibrosis
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
- Trial name
- NCT02976519
- Testing
- BI 443651
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Hypovolemia, Craniosynostoses
Bedside Resources to Gauge Intravascular Volume Status
The goal if this study is to employ the CardioQ-Esophageal Aortic Doppler probe to define fluid responders from non-responders among infants undergoing cranial vault reconstruction for craniosynostosis.
- Trial name
- NCT03915587
- Testing
- CardioQ-EDM and CipherOx-CRI
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Colorado, Denver
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
BPD Saturation TARgeting
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD.
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
- Trial name
- BPD STAR (NCT03385330)
- Testing
- LOWER oxygen saturation target group, HIGHER oxygen saturation target group
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Philadelphia
Neonatal Jaundice, Hyperbilirubinemia
Implementation of a Transcutaneous Bilirubinometer
Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample.
- Trial name
- NCT01622699
- Testing
- Transcutaneous Bilirubinometer, visual assessment of neonatal jaundice
- Where
- Netherlands
- Volunteers
- 430 people
- Sponsor
- Princess Amalia Children's Clinic
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Cystic Fibrosis
STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using Integration Of Fitness Technology and Port CF.
- Trial name
- NCT04018495
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medical College of Wisconsin
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1…
- Trial name
- ELIXIR (NCT02248922)
- Testing
- TIS or TIP
- Where
- 6 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
Cystic Fibrosis
Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis
This is a prospective, multicenter, observational study designed to collect gastrointestinal related data in patients with Cystic Fibrosis (CF).
- Trial name
- GALAXY (NCT03801993)
- Where
- 26 sites in United States
- Volunteers
- 402 people
- Sponsor
- Chris Goss
Congenital Hyperinsulinism
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy.
- Trial name
- NCT00835328
- Testing
- Exendin (9-39), Vehicle
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Diva De Leon
Dermatitis, Atopic
Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
- Trial name
- NCT00152464
- Testing
- Levocetirizine
- Volunteers
- 514 people
- Sponsor
- UCB Pharma SA
Transient Tachypnea of the Newborn
Fluid Management in Transient Tachypnea of the Newborn
Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and 42 weeks gestation who develop difficulty breathing during the first days of life when no specific cause of the breathing difficulty can…
- Trial name
- NCT01225029
- Testing
- Amount of total fluids
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main…
- Trial name
- EPIC (NCT00097773)
- Testing
- Tobramycin solution for inhalation (TOBI), Oral ciprofloxacin
- Where
- 54 sites in United States
- Volunteers
- 304 people
- Sponsor
- Seattle Children's Hospital
Congenital Hypothyroidism
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs.
- Trial name
- NCT02374593
- Testing
- Levothyroxine, Ultrasound
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Erica Eugster