Clinical trials: Infant, Newborn, Disease
Retinopathy of Prematurity, Preterm Infants
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected…
- Trial name
- NCT06315556
- Testing
- Aflibercept (Eylea)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bayer
Cystic Fibrosis
Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI
This is an observational cohort study building on an existing protocol at our institution recruiting CF patients who are 6-21 years old with one or two copies of the F508del CFTR mutation.
- Trial name
- NCT03593434
- Testing
- hyperpolarized Xenon gas
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Patent Ductus Arteriosus, Neonate
Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation.
- Trial name
- NCT03103022
- Testing
- Acetaminophen, ibuprofen
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Cystic Fibrosis (CF)
Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis
The goal of this clinical trial is to support the development of personalized therapy tailored to each patient's individual characteristics.
- Trial name
- NCT07809867
- Testing
- Elexacaftor, Tezacaftor, Ivacaftor, Ivacaftor (VX-770)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Giannina Gaslini
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
Congenital Heart Disease
Impact of Early Enteral Feeding on Splanchnic Blood Flow After Surgery for Critical Heart Disease in the Newborn
The objective of this study is to determine the impact of early post-operative feeding on splanchnic blood flow, cardiac output and end organ perfusion, and the patients overall clinical outcomes.
- Trial name
- NCT00919945
- Testing
- Continuous feeding at time 1 and NPO at time 2, NPO at time 1 and continuous feeding at time 2
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- The Hospital for Sick Children
Cystic Fibrosis
Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat absorption, as well as safety and tolerability of sustained RELiZORB…
- Trial name
- ASSURE (NCT02750501)
- Testing
- RELiZORB (immobilized lipase) cartridge, Impact Peptide 1.5
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Alcresta Therapeutics, Inc.
Jaundice, Neonatal
Transcutaneous Bilirubinometers in the Community
Jaundice is the most frequent reason for readmission for healthy newborns after discharge from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy newborns were admitted to the hospital for…
- Trial name
- TcB RCT (NCT00735319)
- Testing
- Transcutaneous Bilirubinometer
- Where
- 6 sites in Canada
- Volunteers
- 10,000 people
- Sponsor
- University of Alberta
Prematurity, Neurodevelopmental Disorder
Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants
Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life.
- Conditions
- Prematurity, Neurodevelopmental Disorder, Carnitine Deficiency
- Trial name
- NCT01783041
- Testing
- L-carnitine, 5% Dextrose
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- Montefiore Medical Center
Infant, Premature, Hypoperfusion in Newborn
Monitoring of Systemic or Organ Perfusion for Preterm Infants
To investigate biomarker reflects systemic or specific organ perfusion well, we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants.
- Conditions
- Infant, Premature, Hypoperfusion in Newborn, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- Trial name
- NCT03136172
- Testing
- NIRS (near Infra-red spectroscopy)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Inha University Hospital
Respiratory Failure, Mechanical Ventilation Complication
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
The purpose of this study is to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
- Trial name
- NavPed-NI (NCT01238757)
- Testing
- Non-invasive Ventilation under Pressure Support, Non-Invasive ventilation under NAVA
- Where
- Switzerland
- Volunteers
- 7 people
- Sponsor
- University Hospital, Geneva
Cystic Fibrosis, Abdominal Pain
An Investigation of the Association Between Helicobacter Pylori Infection and Abdominal Pain in Cystic Fibrosis Patients
Cystic fibrosis (CF) is the most common lethal autosomal recessive disease among Caucasians. While the pulmonary disease in CF receives most of the attention, gastrointestinal diseases occur in >95% of CF individuals and can…
- Conditions
- Cystic Fibrosis, Abdominal Pain, Helicobacter Pylori Infection
- Trial name
- NCT00765401
- Where
- United States
- Sponsor
- Penn State University
Congenital Heart Defects, Underweight
Nutrition In Preoperative Pediatric Congenital Heart Disease
Introduction: The use of a nutritional protocols provides the standardization of assessment procedures and the optimization of nutritional status recovery of pre-surgical infants with Congenital Heart Disease (CHD).
- Trial name
- NCT05457712
- Testing
- protocol, Control
- Volunteers
- 118 people
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
Safety Issues, Effect of Drugs
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Trial name
- NCT03760900
- Testing
- Autologous Umbilical Cord Blood Stem Cells Therapy
- Volunteers
- 15 people
- Sponsor
- Guangdong Women and Children Hospital
Infant, Premature, Anticoagulants
Heparin Versus no Heparin on Duration of Peripherally Inserted Central Catheter (PICC) Patency in Neonates
Background: Heparin is an anticoagulant commonly used in the neonatal population as a means to prevent catheter related occlusion and malfunction by thrombosis (clot).
- Conditions
- Infant, Premature, Anticoagulants, Thrombosis
- Trial name
- NCT00879957
- Testing
- heparin, No heparin
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
Apnea of Prematurity, Infant, Premature, Diseases
Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in…
- Trial name
- Osciflow (NCT04327466)
- Testing
- Osciflow, Highflow
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University of Zurich
Language Delay, Language Development
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings…
- Conditions
- Language Delay, Language Development, Feeding; Difficult, Newborn, Mother-Infant Interaction
- Trial name
- NCT05861531
- Testing
- Oromotor stimulation, Reading curriculum, LENA recording
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related…
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations
- Trial name
- DINE (NCT05723445)
- Testing
- Low Glycemic Load Diet
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Rhode Island Hospital
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
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