Clinical trials: Infant
Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist
NAVA vs. CMV Crossover in Severe BPD
This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered…
- Conditions
- Bronchopulmonary Dysplasia, Neurally Adjusted Ventilatory Assist, Mechanical Ventilation
- Trial name
- NCT04821453
- Testing
- NAVA, CMV
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Children's Hospital of Philadelphia
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Neonatal Abstinence Syndrome
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.
- Trial name
- NCT04419857
- Testing
- High-calorie formula
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Yale University
Family Relationship, Stress
Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Family Relationship, Stress, Breastfeeding, Bottle Feeding
- Trial name
- NCT02901665
- Testing
- FCC intervention
- Where
- 2 sites in United States
- Volunteers
- 191 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Cystic Fibrosis
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.
- Trial name
- NCT01315665
- Testing
- Broccoli sprouts
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Gestational Weight Gain
My Baby My Move A Community Wellness Intervention
My Baby, My Move+ (2019-2021) is a peer-led wellness intervention which aims to reduce excessive gestational weight gain (EGWG) by targeting prenatal physical activity, mood, and sleep quality.
- Trial name
- MBMM+ (NCT04294095)
- Testing
- My Baby My Move +, Control
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Colorado, Denver
Cystic Fibrosis
Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents
The purpose of this study is to characterize the rheological properties of cystic fibrosis (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF and healthy sputum.
- Trial name
- GIST (NCT00758771)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Focus: Nutritional Requirements for Infants
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses.
- Trial name
- NCT02092857
- Testing
- Arachidonic acid (25 mg/100 kcal ), Arachidonic acid (34 mg/100 kcal)
- Where
- Canada
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Cystic Fibrosis
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have an…
- Trial name
- NCT02725567
- Testing
- IVA
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 57 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Adolescent Mothers, Infant Obesity
Tools For Teen Moms: Reducing Infant Obesity Risk
The purpose of this social media group randomized trial (GRT) is to test the feasibility of our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues and implement healthy feeding practices…
- Trial name
- TFTM (NCT02244424)
- Testing
- Tools for Teen Moms
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Michigan State University
Respiratory Syncytial Virus (RSV), Lower Resp Tract Infection
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections.
- Trial name
- REVIRAL 1 (NCT04225897)
- Testing
- RV521
- Where
- 60 sites in Argentina, Canada and 13 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Achondroplasia
A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia
Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.
- Trial name
- NCT03583697
- Testing
- BMN 111
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 75 people
- Sponsor
- BioMarin Pharmaceutical
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Cystic Fibrosis
Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and…
- Trial name
- NCT02178540
- Testing
- Tobi Podhaler
- Where
- 13 sites in United States
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Early Intervention
Effectiveness of Telerehabilitation in High Risk of Infants
While the mortality rate in preterm births has decreased thanks to recent developments in the field of medicine, disability risk factors increase for premature babies.
- Trial name
- NCT05333224
- Testing
- Telerehabilitation, Home-based
- Where
- Turkey (Türkiye)
- Volunteers
- 26 people
- Sponsor
- Saglik Bilimleri Universitesi
Cystic Fibrosis
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized.
- Trial name
- DOXY (NCT01112059)
- Testing
- Doxycycline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Rotavirus Disease
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants.
- Trial name
- NCT01926015
- Testing
- RotaTeq™ (V260), DTP-IPV
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Blood Flow and Vascular Function in Cystic Fibrosis
Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections.
- Trial name
- CF-FLOW (NCT02057458)
- Testing
- Sildenafil (Acute-1 hour), Sildenafil (Subchronic-4 weeks)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Augusta University