Clinical trials: Newborn Infant
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
Jaundice, Neonatal
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
- Trial name
- NCT05650463
- Testing
- Picterus Jaundice Pro
- Where
- Sweden
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Cystic Fibrosis
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.
- Trial name
- NCT01840735
- Testing
- GS-5737
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Gilead Sciences
Infant Nutritional Physiological Phenomena, Infant Formula
Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
- Trial name
- NCT05097924
- Testing
- NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
- Where
- Saudi Arabia
- Volunteers
- 150 people
- Sponsor
- Société des Produits Nestlé (SPN)
Dermatitis, Atopic
Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis
The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment.
- Trial name
- NCT00535691
- Testing
- Tacrolimus Ointment 0.03%
- Where
- 8 sites in Canada, Finland and 3 more
- Volunteers
- 53 people
- Sponsor
- Astellas Pharma Inc
Irritable Bowel Syndrome
Multicenter Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
Observational Prospective Study to Describe Irritable Bowel Syndrome in the Russian Federation
- Trial name
- ROMERUS (NCT03549143)
- Testing
- IBS
- Where
- 37 sites in Russia
- Volunteers
- 1,000 people
- Sponsor
- Abbott
Hunter Syndrome
A Study of GC1111 in Hunter Syndrom Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Trial name
- NCT03920540
- Testing
- GC1111, Comparator
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Green Cross Corporation
Bacterial Infections
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
- Trial name
- NCT02688790
- Testing
- Dalbavancin
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- AbbVie
Congenital Heart Defects, Blood Platelet Disorders
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)
PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet…
- Trial name
- NCT00115375
- Testing
- Clopidogrel (SR25990)
- Where
- 6 sites in United States, Belgium and 4 more
- Volunteers
- 92 people
- Sponsor
- Sanofi
Cystic Fibrosis
Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
The primary objective of this study is to evaluate the safety and tolerability of a single dose of KB001 in Cystic Fibrosis patients infected with Pseudomonas aeruginosa (Pa)
- Trial name
- NCT00638365
- Testing
- KB001
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Humanigen, Inc.
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
To show the superiority in safety of Smoflipid over Intralipid® as measured by the number of study patients in each treatment group with conjugated bilirubin exceeding 2 mg/dL during the first 28 days of study treatment…
- Trial name
- NCT02579265
- Testing
- Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Fresenius Kabi
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance…
- Trial name
- NCT01705145
- Testing
- Ivacaftor
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 35 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Atopic Dermatitis, Eczema
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
There is a lack of prospective scientific data on the regular use of moisturizers in patients at risk of developing atopic dermatitis.
- Conditions
- Atopic Dermatitis, Eczema, Asthma, Food Allergies
- Trial name
- NCT01577628
- Testing
- Lipikar Balm AP
- Where
- 4 sites in United States, Canada
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
Mucopolysaccharidosis II
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity…
- Trial name
- NCT04007536
- Testing
- No Intervention
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 18 people
- Sponsor
- Denali Therapeutics Inc.
Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm…
- Trial name
- NCT06114992
- Testing
- Servo-n HFOV modes
- Where
- 4 sites in France, Poland and 1 more
- Volunteers
- 83 people
- Sponsor
- Maquet Critical Care AB
Persistent Pulmonary Hypertension of the Newborn
Persistent Pulmonary Hypertension of the Newborn
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the…
- Trial name
- FUTURE 4 (NCT01389856)
- Testing
- Bosentan
- Volunteers
- 23 people
- Sponsor
- Actelion
Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
- Conditions
- Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor, Uterine Contractions, Obstetric Complication
- Trial name
- NCT05782296
- Testing
- TrueLabor
- Where
- 3 sites in United States, Israel
- Volunteers
- 80 people
- Sponsor
- OB-Tools Ltd.
Catheter, Newborn, Infant, Disease
Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal intensiVE Care Patients -2
The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has…
- Conditions
- Catheter, Newborn, Infant, Disease, Lung Diseases
- Trial name
- IMPROVE-2 (NCT05433779)
- Testing
- Neosense Umbilical Catheter
- Where
- 5 sites in Sweden
- Volunteers
- 8 people
- Sponsor
- Neosense Technologies
Cystic Fibrosis
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in…
- Trial name
- NCT00800579
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Chagas Disease
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
- Trial name
- NCT05477953
- Testing
- Nifurtimox (BAYA2502)
- Where
- 12 sites in United States, Argentina and 10 more
- Volunteers
- 50 people
- Sponsor
- Bayer