Clinical trials: Infant Term Birth
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00694109
- Testing
- Mipomersen Sodium
- Where
- 33 sites in United States, Brazil and 5 more
- Volunteers
- 144 people
- Sponsor
- Kastle Therapeutics, LLC
Parent-Child Relations, Parents
Therapist Education and Massage for Parent Infant-Outcomes
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant…
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Trial name
- TEMPO (NCT04121897)
- Testing
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Retinopathy of Prematurity (ROP)
Rainbow Extension Study
The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study…
- Trial name
- RainbowExt (NCT02640664)
- Testing
- Ranibizumab
- Where
- 73 sites in United States, Austria and 22 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Anemia, Sickle Cell
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)
Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA.
- Trial name
- NCT00890396
- Testing
- Hydroxyurea
- Where
- 14 sites in United States
- Volunteers
- 163 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Pain
Topical Amethocaine Gel for Intramuscular Injection in Term Neonates
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.
- Trial name
- NCT00267111
- Testing
- Eucerin plus, Amethocaine gel 4%
- Where
- Canada
- Volunteers
- 110 people
- Sponsor
- Mount Sinai Hospital, Canada
Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis
The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.
- Trial name
- NCT01931839
- Testing
- Lumacaftor Plus Ivacaftor Combination, Ivacaftor
- Where
- 166 sites in United States, Australia and 13 more
- Volunteers
- 1,164 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Magnetic Resonance Imaging
Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years.
- Trial name
- NCT01544166
- Testing
- Gadobutrol (Gadavist, BAY86-4875)
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 44 people
- Sponsor
- Bayer
PPHN, Persistent Pulmonary Hypertension of the Newborn
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
- Conditions
- PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
- Trial name
- NCT01069861
- Testing
- sildanefil
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
Lung Disease
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy…
- Trial name
- NCT00551642
- Testing
- Nitric oxide
- Where
- 35 sites in Belgium, Finland and 7 more
- Volunteers
- 800 people
- Sponsor
- Mallinckrodt
Cystic Fibrosis
Rollover Study of VX-770 in Cystic Fibrosis Subjects
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT01117012
- Testing
- Ivacaftor
- Where
- 58 sites in United States, Australia and 6 more
- Volunteers
- 192 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).
- Trial name
- NCT03625466
- Testing
- LUM/IVA
- Where
- 5 sites in Germany
- Volunteers
- 51 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis B, Pertussis
Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)
This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old…
- Trial name
- NCT02759354
- Testing
- Blood Sample
- Volunteers
- 754 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
Cystic Fibrosis
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744)…
- Trial name
- NCT02565914
- Testing
- TEZ/IVA, IVA
- Where
- 154 sites in United States, Australia and 14 more
- Volunteers
- 1,131 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Haemophilus Influenzae Type b, Neisseria Meningitidis
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta)…
- Trial name
- NCT00586612
- Testing
- Menitorix™, Infanrix™ penta, Prevenar™
- Where
- 8 sites in Spain
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
PTC Study to Evaluate Ataluren in Combination With Ivacaftor
The purpose of this study is to explore the combination of ataluren and ivacaftor as a treatment for patients with nonsense mutation cystic fibrosis
- Trial name
- NCT03256968
- Testing
- Ataluren
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Alabama at Birmingham
Ichthyosis
An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses
The ichthyoses are a group of lifelong genetic disorders that share characteristics of generalized skin thickening, scaling and underlying cutaneous inflammation.
- Trial name
- NCT04549792
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Northwestern University