Clinical trials: Infant, Newborn
Cystic Fibrosis
Absorptive Clearance in the Cystic Fibrosis Airway
The objective of this overall project is to develop a new aerosol-based technique for quantifying liquid absorption in the airways of subjects with cystic fibrosis(CF) that can be used to help develop new therapies.
- Trial name
- NCT00541190
- Testing
- Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Maternal Death, Maternal Infections Affecting Fetus or Newborn
Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths.
- Conditions
- Maternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During Labor
- Trial name
- NCT03871491
- Testing
- Azithromycin
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 58,747 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
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
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Benign Breast Disease, Fibrocystic Disease of Breast
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor…
- Conditions
- Benign Breast Disease, Fibrocystic Disease of Breast, Fibroadenoma, Mastalgia
- Trial name
- NCT00999921
- Testing
- Tamoxifen, Evening Primrose Oil
- Where
- India
- Volunteers
- 256 people
- Sponsor
- Medical College and Hospital Kolkata
Cystic Fibrosis-related Diabetes, Cystic Fibrosis
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients…
- Trial name
- NCT06149793
- Testing
- Empagliflozin
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Minnesota
Liver Disease
Magnetic Resonance Elastography in Infants
MRI \& MRE in infants
- Trial name
- MREI (NCT02201472)
- Testing
- MRI with MRE
- Volunteers
- 2 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Gram-negative Bacterial Infection
Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.
This study will assess the pharmacokinetics, safety, and tolerability of single and multiple doses of intravenous ceftazidime-avibactam in hospitalized infants and neonates from 26 weeks gestation to 3 months of age.
- Trial name
- NOOR (NCT04126031)
- Testing
- Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3, Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3
- Where
- 18 sites in United States, Estonia and 6 more
- Volunteers
- 48 people
- Sponsor
- Pfizer
Cystic Fibrosis
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs.
- Trial name
- PIPE-CF (NCT01694069)
- Testing
- Piperacillin-tazobactam combination product
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- West Virginia University
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00477594
- Testing
- mipomersen sodium
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Kastle Therapeutics, LLC
Persistent Pulmonary Hypertension of the Newborn
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
This study assessed the safety and treatment effect of intravenous (IV) Remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (PPHN).
- Trial name
- NCT02261883
- Testing
- IV Remodulin
- Where
- 14 sites in United States
- Volunteers
- 42 people
- Sponsor
- United Therapeutics
Preterm Infants
NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a…
- Trial name
- NCT03099694
- Testing
- noninvasive high-frequency ventilation (nHFOV), nasal continuous positive airway pressure (nCPAP)
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Xingwang Zhu
Bacteria Infection, Respiratory Tract Infections
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection…
- Trial name
- NCT00599053
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis
28 Day Repeat Dose in Cystic Fibrosis Patients
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis
- Trial name
- NCT00903201
- Testing
- SB656933
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 146 people
- Sponsor
- GlaxoSmithKline
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
Intubation
Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
- Trial name
- NCT01163656
- Testing
- Miller Laryngoscope, Glidescope Cobalt Video Laryngoscopes
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Children's Hospital of Philadelphia
Cystic Fibrosis
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and…
- Trial name
- NCT02951195
- Testing
- VX-152, TEZ/IVA, IVA
- Where
- 16 sites in United States
- Volunteers
- 80 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency
Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency
This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL…
- Conditions
- Cholesterol Ester Storage Disease(CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
- Trial name
- NCT01307098
- Testing
- Sebelipase alfa 0.35 mg/kg, Sebelipase alfa 1 mg/kg, Sebelipase alfa 3 mg/kg
- Where
- 7 sites in United States, Czechia and 2 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals