Clinical trials: Dysphagia of Newborn
Dysphagia of Newborn
Cold Milk for Dysphagia in Preterm Infants
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal…
- Trial name
- NCT04421482
- Testing
- Standard room temperature (RTS) feeding of milk/formula, Cold temperature (CS, at 4-9°C) of milk/formula
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- NYU Langone Health
Gastroesophageal Reflux Disease
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
- Trial name
- NCT00174928
- Testing
- Lansoprazole
- Volunteers
- 24 people
- Sponsor
- Takeda
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
Gastroesophageal Reflux, Apnea
Study of Erythromycin in GER-Associated Apnea of the Newborn
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective…
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia
- Trial name
- SEGAN (NCT01825473)
- Testing
- Erythromycin, Multi-channel intra-luminal impedance (MII) pH monitoring
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Infant Nutrition Disorders, Gastrointestinal Dysfunction
Management of Infant Digestive Disorders and Quality of Life
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
- Trial name
- NCT04462640
- Testing
- Management of Infant Digestive Disorders and Quality of Life
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gastroesophageal Reflux Disease (GERD)
Optimal Dosing of Omeprazole in Neonates
"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the…
- Trial name
- OMEPRAZOLE-1 (NCT01657578)
- Testing
- Omeprazole
- Where
- France
- Volunteers
- 55 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Gastroesophageal Reflux
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.
- Trial name
- NCT00855361
- Testing
- Rabeprazole sodium
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 69 people
- Sponsor
- Janssen Research & Development, LLC
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
Dysphagia of Newborn
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Preterm infants often have difficulty learning how to feed by mouth because the coordination of sucking, swallowing, and breathing develops later in pregnancy.
- Trial name
- Music therapy (NCT07819734)
- Testing
- Pacifier-Activated Lullaby (PAL) Therapy
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Gastroesophageal Reflux Disease
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
The overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New treatments can be possible only if the cause is known.
- Trial name
- GMT (NCT02486263)
- Testing
- Study Arm - acid suppression plus feeding bundle, Conventional arm - acid suppression only
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Sudarshan Jadcherla
Oesophageal Atresia, Dumping Syndrome
Dumping Syndrome and Esophageal Atresia
Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood.
- Trial name
- DUMTORING (NCT04522193)
- Testing
- Glycemic Holter, gastric emptying scintigraphy, Holter ECG
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Lille
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
Cystic Fibrosis
The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation
Gastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary aspiration.
- Trial name
- NCT00164021
- Testing
- Physiotherapy, exercise, percutaneous gastrostomy feeds, Anti-reflux pharmacotherapy
- Where
- Australia
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bayside Health
Deglutition Disorders
Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic…
- Trial name
- NCT02003287
- Testing
- VFSS, FEES
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute
Gastroesophageal Reflux, Presumed Sepsis
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
The purpose of this research is to address the comparative effectiveness and harm of the therapeutics frequently given to pregnant women and their young infants including antibiotics, tocolytic agents, non-steroidal…
- Conditions
- Gastroesophageal Reflux, Presumed Sepsis, Patent Ductus Arteriosus, Chronic Lung Disease
- Trial name
- NCT01028183
- Where
- United States
- Sponsor
- Duke University
Nutrition Disorders, Gastrointestinal Disease
Review of Infant Oral Feeding and Skills
This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral…
- Conditions
- Nutrition Disorders, Gastrointestinal Disease, Deglutition Disorder, Feeding Difficulties
- Trial name
- RIOS (NCT06736743)
- Testing
- SMART Tool for Feeding Skill Assessment
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wake Forest University Health Sciences
Functional Gastrointestinal Disorders, Gastroesophageal Reflux
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first…
- Conditions
- Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea
- Trial name
- FUSID (NCT06031025)
- Testing
- Questionnaire, clinical examination
- Where
- Italy
- Volunteers
- 71 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Oculopharyngeal Muscular Dystrophy (OPMD)
Natural History of Oculo-Pharyngeal Muscular Dystrophy (OPMD) - Israel National OPMD Registry
The goal of this open prospective multi-disciplinary observational study of patients with OPMD at various stages of clinical manifestations is to explore the natural history of the disease in the Israeli population.
- Trial name
- Isr-OPMD (NCT07146256)
- Testing
- Non-interventional observational study
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Sheba Medical Center
Eosinophilic Esophagitis
The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE
The aim of the project is to assess the correlation between the results of high-resolution oesophageal manometry and specific biomarkers of inflammation (eotaxin 3, major basic protein, IL-5, IL-13, TGF-beta1) with symptoms of…
- Trial name
- NCT04803162
- Testing
- High-resolution manometry, Serum biomarkers, Gastrointestinal Quality of Life index
- Where
- Poland
- Volunteers
- 58 people
- Sponsor
- Wroclaw Medical University