Clinical trials: Newborn Infant
A. Longitudinal Cohort n=400, B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention
Study to Understand Risk and Resilience Opportunity for Newborns After Delivery
Childhood Maltreatment (CM) has highly deleterious effects on human development and is a preventable known cause of enduring psychopathology in the United States.
- Trial name
- SURROuND (NCT04438161)
- Testing
- PERCCS: Personalized Education Regarding Clinical and Community Supports
- Where
- United States
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Insurance Status/Stability
IMPACCT for Kids' Care
Health insurance is important for children. Public insurance programs are available to many children, but some families report being confused about how to get and keep this insurance.
- Trial name
- IMPACCT (NCT02298361)
- Testing
- Health insurance outreach IT tools
- Volunteers
- 27,251 people, healthy volunteers welcome
- Sponsor
- OCHIN, Inc.
Respiratory Tract Diseases, Abnormal Mucus Secretions
A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial.
- Trial name
- NCT03843541
- Testing
- N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg
- Where
- 32 sites in China
- Volunteers
- 333 people
- Sponsor
- Zambon SpA
Cystic Fibrosis
Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped.
- Trial name
- SIMPLIFY (NCT04378153)
- Where
- 80 sites in United States
- Volunteers
- 987 people
- Sponsor
- Nicole Hamblett
Cystic Fibrosis
Comparative Analysis of CO2 Monitoring Methods in Patients With CF Undergoing General Anesthesia
Four methods are routinely used to monitor CO2 in patients. End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
- Trial name
- NCT03734822
- Testing
- End tidal CO2 (EtCO2), Transcutaneous CO2 (TCO2), Capillary CO2 (CapCO2)
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Nationwide Children's Hospital
Exocrine Pancreatic Insufficiency, Steatorrhea
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic…
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Trial name
- NCT00662675
- Testing
- Pancrease MT 10.5, or MT 21
- Where
- 11 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Netherton Syndrome
Natural History of Netherton Syndrome
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).
- Trial name
- NCT05902663
- Where
- 4 sites in United States, Italy
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Nursing Caries, Newborn
The Effect of the Mobile Application Developed for the Care of Sick Newborns
The goal of this randomize controlled trial determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that…
- Trial name
- NCT05776615
- Testing
- mobile application
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Kutahya Health Sciences University
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two…
- Trial name
- NCT02249143
- Testing
- CPAP and room air
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Oregon Health and Science University
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing…
- Trial name
- ENCORE (NCT03597347)
- Testing
- Molgramostim nebulizer solution, PARI eFlow nebulizer system
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Savara Inc.
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Cystic Fibrosis
Extension Study of Ataluren (PTC124) in Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein.
- Trial name
- NCT01140451
- Testing
- Ataluren
- Where
- 31 sites in United States, Belgium and 9 more
- Volunteers
- 191 people
- Sponsor
- PTC Therapeutics
Candidiasis, Invasive
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants.
- Trial name
- NCT01945281
- Testing
- Caspofungin, Amphotericin B Deoxycholate
- Volunteers
- 51 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
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 heterozygous for…
- Trial name
- NCT04058353
- Testing
- ELX/TEZ/IVA, IVA, TEZ/IVA
- Where
- 93 sites in United States, Australia and 11 more
- Volunteers
- 271 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
High-Frequency Ventilation
HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level
The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation.
- Trial name
- SighCO2 (NCT05682937)
- Testing
- HFOV-sigh
- Where
- Thailand
- Volunteers
- 30 people
- Sponsor
- Prince of Songkla University
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
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Newborn Infants Having Asystole or Bradycardia at Birth
Chest Compression and Sustained Inflation
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns.
- Trial name
- NCT02083705
- Testing
- CC+SI, 3:1 CPR
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- University of Alberta
Cystic Fibrosis
Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.
- Trial name
- NCT00659529
- Testing
- sildenafil
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- National Jewish Health