Clinical trials: Infant, Newborn
Cystic Fibrosis
Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)
To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF) who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D).
- Trial name
- VOCAL (NCT02445053)
- Testing
- ivacaftor
- Where
- 15 sites in Italy, Netherlands and 1 more
- Volunteers
- 75 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function
This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of…
- Trial name
- NCT01685801
- Testing
- Ivacaftor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Breastfeeding, Patient Simulation
Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop
Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating…
- Trial name
- NCT04717128
- Testing
- Breastfeeding Skills Workshop
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- LiquidGoldConcept
Gastrointestinal Disorder, Functional, Regurgitation, Gastric
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study
To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from…
- Conditions
- Gastrointestinal Disorder, Functional, Regurgitation, Gastric, Colic, Infantile, Constipation - Functional
- Trial name
- TIGER (NCT05363553)
- Testing
- Infant formula based on whole goat milk, infant formula based on cow milk proteins
- Where
- Thailand
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Ichthyosis, Lamellar
Efficacy and Safety of Two Doses of Liarozole vs. Placebo for the Treatment of Lamellar Ichthyosis
Lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. The primary activity of liarozole is considered to be the inhibition of the degradation of a substance called retinoic acid, which is the…
- Trial name
- NCT00282724
- Testing
- Liarozole
- Where
- 16 sites in Belgium, Canada and 7 more
- Volunteers
- 98 people
- Sponsor
- Stiefel, a GSK Company
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
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
Infant Newborn
Effects of Early Nutrition on Growth
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.
- Trial name
- NCT01300000
- Testing
- Human Milk, Investigational infant formula, Milk based standard infant formula
- Where
- United Kingdom
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Meconium Aspiration
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
- Trial name
- NCT00004500
- Testing
- Lucinactant, Standard Care
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Windtree Therapeutics
Cystic Fibrosis
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.
- Trial name
- NCT01460836
- Testing
- Tobramycin solution for inhalation, Aztreonam lysine for inhalation
- Sponsor
- Novartis Pharmaceuticals
Infant Nutrition
A New Adaptive Feeding Plan for Newborns
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
- Trial name
- NCT00984230
- Testing
- BSF, BSF + Lactoferrin + Probiotics, BSF + Lactoferrin + Probiotics + OS
- Where
- 6 sites in Austria, France and 1 more
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Insomnia
Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®
This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.
- Trial name
- NCT06498128
- Testing
- Daridorexant, Non-orexin receptor antagonist medications for insomnia, No insomnia medication
- Where
- 7 sites in United States, Canada and 5 more
- Volunteers
- 785 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
- Trial name
- EARLY (NCT01082367)
- Testing
- TOBI
- Where
- 19 sites in Canada, Egypt and 8 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
PR-018: An Open-Label, Safety Extension of Study PR-011
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to…
- Trial name
- NCT01131507
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Chronic Rhinosinusitis, Cystic Fibrosis
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical…
- Trial name
- Respire (NCT03145051)
- Testing
- Saline solution, Respimer Netiflow
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Laboratoire de la Mer
Atopic Dermatitis (AD)
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis
To investigate the efficacy of 0.3% OPA-15406 ointment when administered twice daily for 4 weeks in infants younger than 2 years of age with Atopic Dermatitis
- Trial name
- NCT05372653
- Testing
- OPA-15406
- Where
- Japan
- Volunteers
- 41 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Cystic Fibrosis
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
- Trial name
- NCT03460990
- Testing
- VX-659/TEZ/IVA, TEZ/IVA, IVA
- Where
- 46 sites in United States, Australia and 4 more
- Volunteers
- 116 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Urea Cycle Disorders, Carbamoylphosphate Synthetase I Deficiency
Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders
Urea cycle disorders are rare inherited diseases that generally have a poor outcome. In this study, neonates and infants with UCD will be included within the first 3 months of life and will be treated by repetitive application of…
- Conditions
- Urea Cycle Disorders, Carbamoylphosphate Synthetase I Deficiency, Ornithine Transcarbamylase Deficiency, Citrullinemia
- Trial name
- NCT00718627
- Testing
- Human Heterologous Liver Cells
- Where
- 2 sites in Germany
- Volunteers
- 12 people
- Sponsor
- Cytonet GmbH & Co. KG
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
SD Cystic Fibrosis Study
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability.
- Trial name
- NCT00605761
- Testing
- SB656933
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GlaxoSmithKline