Clinical trials: Dysphagia of Newborn
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Infantile Colic, Constipation
Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food…
- Conditions
- Infantile Colic, Constipation, Infantile Diarrhea, Gastro Esophageal Reflux
- Trial name
- NCT04262648
- Testing
- Lactobacillus Reuteri
- Where
- 2 sites in Russia
- Volunteers
- 90 people
- Sponsor
- NovoNatum Ltd
Dysphagia, Esophageal Stricture
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
This is a prospective, single-center, crossover study comparing EndoFLIP measurements obtained in two patient positions, supine and left lateral decubitus, in pediatric and young adult patients.
- Conditions
- Dysphagia, Esophageal Stricture, Epidermolysis Bullosa (EB), Achalasia
- Trial name
- NCT07780981
- Testing
- EndoFlip
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Johns Hopkins University
Oculopharyngeal Muscular Dystrophy
Treatment of Oculopharyngeal Muscular Dystrophy With Trehalose
BB-OPMD-202 is a randomized, double-blind, placebo-controlled study of IV trehalose for treatment of OPMD. The study includes a 4-week screening period, a 24-week blinded treatment period during which patients will receive weekly…
- Trial name
- NCT04226924
- Testing
- Trehalose
- Where
- 3 sites in Canada
- Sponsor
- Bioblast Pharma Ltd.
Muscular Dystrophy, Oculopharyngeal
Treatment of Dysphagia in Oculopharyngeal Muscular Dystrophy by Autologous Transplantation of Myoblasts
The OCULO-Pharyngeal Muscular Dystrophy (OPMD) is a late onset hereditary muscle disease which is characterised by the selective affection of the pharyngeal muscles resulting in swallowing disorders, and by a ptosis from the…
- Trial name
- OPMD (NCT00773227)
- Testing
- Autologous myoblasts transplantation and myotomy
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Friedreich Ataxia
Efficacy of Omaveloxolone Treatment for Dysphagia in French Patients With Friedreich's Ataxia
Friedreich's ataxia (FA) is a rare, inherited neurodegenerative disease that typically begins in children and young people. It primarily affects the spinal cord, peripheral nerves and cerebellum of the brain.
- Trial name
- NCT07013292
- Testing
- SKYCLARYS (omaveloxolone)
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Trial name
- NCT00362609
- Testing
- pantoprazole
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Functional Gastrointestinal Disorders, Infant Conditions
Prevalence of FGIDs and Probiotics Study
This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus…
- Trial name
- PROOF (NCT06309199)
- Testing
- Biogaia
- Where
- Thailand
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
GERD
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
- Trial name
- NCT00427635
- Testing
- Esomeprazole
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Oculopharyngeal Muscular Dystrophy
A Study to Evaluate the Safety and Clinical Activity of Intramuscular Doses of BB-301 Administered to Subjects With Oculopharyngeal Muscular Dystrophy With Dysphagia
Subjects who have enrolled in the oculopharyngeal muscular dystrophy (OPMD) natural history study (Study BNTC-OPMD-NH-001) and have completed at least 6 months of follow up in Study BNTC-OPMD-NH-001 may be eligible to participate…
- Trial name
- NCT06185673
- Testing
- BB-301: Dose escalation phase 1b cohort 1, BB-301: Dose escalation phase 1b cohort 2, BB-301: Dose escalation phase 1b cohort 3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Benitec Biopharma, Inc.
Cervical Spine Fusion
Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor
The purpose of this study is to assess the function and reliability of a noninvasive, skin-like electronic sensor. The investigators hypothesize that this skin sensor will address an unmet need to wirelessly and noninvasively…
- Trial name
- NCT04921800
- Testing
- Anterior Cervical Discectomy & Fusion, Application of ADAM mechanoacoustic skin sensor
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Northwestern University
Dysphagia of Newborn
Development of Dysphagia Evaluation Via Video Analysis Based on Deep Learning Method in Neonates and Infants and Correlation Between the Evaluation and the Development
The purpose of this study is to develop an evaluation of dysphagia through deep learning-based video analysis in newborns and infants, and to report the correlation with future development.
- Trial name
- NCT05204966
- Testing
- AI analysis
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Asan Medical Center
Infantile Colic, Gastroesophageal Reflux (GER)
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome.
- Conditions
- Infantile Colic, Gastroesophageal Reflux (GER), Functional Constipation, Functional Diarrhea
- Trial name
- CTBE2503 (NCT07148583)
- Testing
- BioAmicus Complete, Usual Care (No Probiotic)
- Where
- Vietnam
- Volunteers
- 110 people
- Sponsor
- Haiphong University of Medicine and Pharmacy
Colic, Infantile, Milk Allergy, Cow's
Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)
It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families.
- Conditions
- Colic, Infantile, Milk Allergy, Cow's, Gastro Oesophageal Reflux Disease, Atopic Dermatitis (Eczema)
- Trial name
- NCT07121062
- Testing
- Online parent administered questionnaire
- Where
- United Kingdom
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Gastroesophageal Reflux Disease (GERD)
Phase 3/Safety & Efficacy of Esomeprazole in Infants
The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
- Trial name
- NCT00468559
- Testing
- Open Label Run In Esomeprazole, Double Blind Esomeprazole
- Where
- 25 sites in United States, France and 2 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Food Allergy in Infants, Proctocolitis
Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution
Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive...
- Conditions
- Food Allergy in Infants, Proctocolitis, Atopic Dermatitis, Reflux, Gastroesophageal
- Trial name
- NCT04651829
- Testing
- oral food challenge 1, oral food challenge 2
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hôpital Armand Trousseau
Feeding; Difficult, Newborn, Premature Infant Disease
Psychometric Properties of the SMART Feeding Tool
This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1.
- Conditions
- Feeding; Difficult, Newborn, Premature Infant Disease, Dysphagia of Newborn, Nurse's Role
- Trial name
- NCT05729828
- Where
- 4 sites in United States
- Volunteers
- 76 people
- Sponsor
- Wake Forest University Health Sciences
Gastro Esophageal Reflux
Effect of Right Lateral Position on Ventilated Preterm Neonates
Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates.
- Trial name
- NCT03258528
- Testing
- positioning
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
- Trial name
- GERD-BPD (NCT00926276)
- Testing
- Fundoplication
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Laryngomalacia
Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing…
- Trial name
- NCT07750379
- Testing
- PPI, vitamin D, feeding instruction
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Minia University