Clinical trials: Child Birth
Small for Gestational Age
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
- Trial name
- NCT00537914
- Testing
- Omnitrope
- Where
- 31 sites in Belgium, Czechia and 5 more
- Volunteers
- 278 people
- Sponsor
- Sandoz
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
- Trial name
- NCT00184717
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 98 people
- Sponsor
- Novo Nordisk A/S
Contrast Enhancement in Magnetic Resonance Imaging, Children
A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)
Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
- Trial name
- NCT05915026
- Testing
- Gadoquatrane (BAY1747846)
- Where
- 34 sites in United States, Argentina and 8 more
- Volunteers
- 105 people
- Sponsor
- Bayer
Thrombotic Thrombocytopenic Purpura (TTP)
A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)
Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body.
- Trial name
- NCT03393975
- Testing
- TAK-755, Standard of care
- Where
- 33 sites in United States, Austria and 7 more
- Volunteers
- 52 people
- Sponsor
- Baxalta now part of Shire
Unilateral Cataract Extraction, Congenital Cataract
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in…
- Trial name
- ILR7 (NCT02132312)
- Testing
- OMS302, Phenylephrine HCl
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeros Corporation
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- NCT01245374
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 103 people
- Sponsor
- Novo Nordisk A/S
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Chemotherapy-induced Nausea and Vomiting
Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to <17 years of…
- Trial name
- NCT01697579
- Testing
- Fosaprepitant, Ondansetron, 5-hydroxytryptamine 3 antagonist
- Volunteers
- 240 people
- Sponsor
- Merck Sharp & Dohme LLC
Thromboembolism
Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates
The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body.
- Trial name
- Einstein Jr (NCT02564718)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 9 sites in Austria, France and 5 more
- Volunteers
- 10 people
- Sponsor
- Bayer
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Attention Deficit Disorder With Hyperactivity
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by…
- Trial name
- NCT00758160
- Testing
- OROS Methylphenidate
- Volunteers
- 296 people
- Sponsor
- Johnson & Johnson Taiwan Ltd
Fetal Growth Retardation
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.
- Trial name
- NCT00174252
- Testing
- Genotonorm (Somatropin)
- Where
- 22 sites in France
- Volunteers
- 57 people
- Sponsor
- Pfizer
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
RSV Infection
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection.
- Trial name
- NCT06784973
- Testing
- Obeldesivir
- Where
- 56 sites in United States, Japan
- Volunteers
- 4 people
- Sponsor
- Gilead Sciences
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Infections, Rotavirus
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of…
- Trial name
- NCT00875641
- Testing
- Health Insurance Database
- Where
- United States
- Volunteers
- 390,659 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obstetric Labour, Premature
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide…
- Trial name
- ARIOS (NCT02292784)
- Testing
- Retosiban, Atosiban
- Where
- 26 sites in United States, Belgium and 9 more
- Volunteers
- 98 people
- Sponsor
- GlaxoSmithKline
Infant, Small for Gestational Age
Genotropin Treatment In Very Young Children Born Small For Gestational Age
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
- Trial name
- EGN (NCT00627523)
- Testing
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- Where
- 17 sites in Belgium, Czechia and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Short Children Born Small for Gestational Age (SGA)
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in…
- Trial name
- SGA (NCT01491854)
- Testing
- Bloodsampling
- Where
- 23 sites in Czechia, Georgia and 4 more
- Volunteers
- 130 people
- Sponsor
- Sandoz