Clinical trials: Newborn Infant
Cystic Fibrosis
Comparison of Airway Clearance Therapy in Cystic Fibrosis Using the Same VEST Therapy Device But With Different Settings
Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine…
- Trial name
- NCT00685035
- Testing
- HFCWC with higher pressure/variable-frequency settings, HFCWC with lower pressure/mid-frequency settings
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Minnesota
Cystic Fibrosis
Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
This study is designed as a masked, two center, randomized, placebo-controlled pilot study to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects with CF and lung infection due to PA.
- Trial name
- NCT02730793
- Testing
- Oral Aztreonam, Nasal Aztreonam
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Virginia Commonwealth University
Cystic Fibrosis
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF).
- Trial name
- NCT01031706
- Testing
- Hypertonic Saline
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of North Carolina, Chapel Hill
Lamellar Ichthyosis
A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis
This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with…
- Trial name
- NCT03738800
- Testing
- CD5789 Cream 200 µg/g, CD5789 Cream 100 µg/g, CD5789 Cream Vehicle
- Where
- 36 sites in United States, Australia and 7 more
- Volunteers
- 65 people
- Sponsor
- Mayne Pharma International Pty Ltd
Cystic Fibrosis
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.
- Trial name
- NCT01262352
- Testing
- Ivacaftor
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 21 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for…
- Trial name
- NCT04105972
- Testing
- ELX/TEZ/IVA, TEZ/IVA, IVA
- Where
- 35 sites in Australia, Belgium and 2 more
- Volunteers
- 176 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Infant, Premature, Patent Ductus Arteriosus
Management of the PDA Trial
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
- Conditions
- Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
- Trial name
- PDA (NCT03456336)
- Testing
- Active Treatment, Expectant Management
- Where
- 19 sites in United States
- Volunteers
- 482 people
- Sponsor
- NICHD Neonatal Research Network
Skin Infections, Bacterial
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Trial name
- NCT00555061
- Testing
- Retapamulin Ointment, 1%
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Colic
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
- Trial name
- NCT01532518
- Testing
- Nepadutant
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Menarini Group
Patent Ductus Arteriosus
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA).
- Trial name
- PIVOTAL (NCT03982342)
- Testing
- Cather closure of patent ductus arteriosus (PDA), Conservative management of patent ductus arteriosus (PDA)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Nationwide Children's Hospital
Neonatal Abstinence Syndrome
Fetal and Infant Effects of Maternal Buprenorphine Treatment
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation…
- Trial name
- NCT01561079
- Testing
- Buprenorphine
- Where
- 2 sites in United States
- Volunteers
- 127 people
- Sponsor
- Johns Hopkins University
Cystic Fibrosis
Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in Cystic Fibrosis (CF) has increased dramatically over the last decade.
- Trial name
- PMEP (NCT01594827)
- Testing
- Inhaled Vancomycin, Rifampin, Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Johns Hopkins University
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
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and…
- Trial name
- NCT02392234
- Testing
- VX-661/Ivacaftor, Ivacaftor
- Where
- 93 sites in United States, Australia and 9 more
- Volunteers
- 248 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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.
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Cystic Fibrosis
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older.
- Trial name
- NCT03451045
- Testing
- Lenabasum 20 mg, Lenabasum 5 mg
- Where
- 105 sites in United States, Austria and 19 more
- Volunteers
- 447 people
- Sponsor
- Corbus Pharmaceuticals Inc.
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
Cystic Fibrosis
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (<) 24 months of age.
- Trial name
- NCT05882357
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 19 sites in Australia, Canada and 5 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development
Maternal Adversity, Vulnerability and Neurodevelopment
Maternal Adversity Vulnerability and Neurodevelopment (MAVAN) project is a prospective community-based, pregnancy and birth cohort of Canadian mother-child dyads.
- Conditions
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Infant Development, Infant Behavior
- Trial name
- MAVAN (NCT03434457)
- Where
- Canada
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute