Clinical trials: Newborn Infant
Cystic Fibrosis, Anemia, Iron-Deficiency
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.
- Trial name
- NCT01755455
- Testing
- Ferrous sulfate 325mg
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Cystic Fibrosis (CF)
: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva.
- Trial name
- NCT03445793
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Jewish Health
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration…
- Trial name
- SIMPLICITY (NCT02734810)
- Testing
- Liprotamase Powder for Oral Solution
- Where
- 21 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anthera Pharmaceuticals
Cystic Fibrosis, Healthy
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis
Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations.
- Trial name
- NCT01880723
- Testing
- Albuterol
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Arizona
Duchenne Muscular Dystrophy
Historically Controlled Trial of Corticosteroids in Young Boys With Duchenne Muscular Dystrophy
While it has been known for many years that corticosteroid use benefits boys with Duchenne Muscular dystrophy (DMD), most clinicians do not consider treating until after age 3 or 4 years of age.
- Trial name
- NCT02167217
- Testing
- Prednisolone
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Washington University School of Medicine
Sickle Cell Anemia
Hydroxyurea Management in Kids: Intensive Versus Stable Dosage Strategies
This is a pilot study, single-blind, randomized, multicenter, therapeutic clinical trial designed to evaluate the feasibility of enrolling infants and toddlers (9 months to 36 months) with sickle cell anemia (SCA; HbSS or…
- Trial name
- NCT03020615
- Testing
- Hydroxyurea
- Where
- 4 sites in United States
- Volunteers
- 58 people
- Sponsor
- St. Jude Children's Research Hospital
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation
Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study
Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2).
- Conditions
- High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation, Newborn Morbidity, Noninvasive Ventilation
- Trial name
- nHFOnSIPPV (NCT04323397)
- Testing
- Non-invasive ventilation
- Where
- Thailand
- Volunteers
- 133 people
- Sponsor
- Prince of Songkla University
Cystic Fibrosis
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis.
- Trial name
- NCT00737100
- Testing
- Tiotropium bromide 5 mcg, tiotropium bromide-low dose-2.5mcg
- Where
- 107 sites in United States, Australia and 9 more
- Volunteers
- 510 people
- Sponsor
- Boehringer Ingelheim
Narcotic Addiction, Neonatal Abstinence Syndrome
Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women
The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and…
- Trial name
- AIM2NAS (NCT01965704)
- Testing
- Ondansetron
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Stanford University
Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia
Glycerin Suppositories to Reduce Jaundice in Premature Infants
The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy.
- Conditions
- Idiopathic Hyperbilirubinemia, Neonatal Hyperbilirubinemia, Prematurity
- Trial name
- NCT01746511
- Testing
- Phototherapy, glycerin suppository
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Cystic Fibrosis
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).
- Trial name
- NCT03601637
- Testing
- LUM, IVA
- Where
- 27 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.
- Trial name
- NCT03061331
- Testing
- LUM/IVA
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
This trial aims to provide prospective evidence of the safety and efficacy of mannitol 400 mg b.i.d. in subjects aged 18 years and above. We hypothesize that inhaled mannitol 400 mg b.i.d.
- Trial name
- NCT02134353
- Testing
- Inhaled mannitol
- Where
- 100 sites in United States, Argentina and 16 more
- Volunteers
- 423 people
- Sponsor
- Syntara
Induction of Labor Affected Fetus / Newborn
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score <6) increases the risk of cesarean section.
- Trial name
- NCT03806231
- Testing
- Outpatient Dinoprostone 10mg, Inpatient Dinoprostone 10 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Intermountain Health Care, Inc.
Cystic Fibrosis
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).
- Trial name
- NCT03768089
- Testing
- VX-121 (Suspension), TEZ/IVA, IVA
- Where
- 7 sites in Netherlands, United Kingdom
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
PPROM, Respiratory Distress Syndrome in Premature Infants
Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care…
- Trial name
- NCT02939742
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Premature Infant Disease, Family Research
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy
- Trial name
- NCT04638127
- Testing
- PREEMIE PROGRESS, Attention Control
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati