Clinical trials: Infant, Newborn
Colic
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
- Trial name
- NCT01532518
- Testing
- Nepadutant
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Menarini Group
Cystic Fibrosis
The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients
Insulin replacement therapy may be effective in breaking the cycle of protein catabolism, undernutrition and overall clinical deterioration in pre-diabetic, insulin insufficient CF youth because of its potent anabolic effect.
- Trial name
- NCT02496780
- Testing
- novolog insulin, levemir insulin
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Heart Defects, Congenital, Cardiopulmonary Bypass
Nesiritide Use Following Cardiac Surgery in Infants
The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.
- Trial name
- NCT00281671
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Boston Children's Hospital
Neonatal Brachial Plexus Palsy
NMES Efficacy on Patients With NBPP
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm.
- Trial name
- NCT01999465
- Testing
- Standard NMES device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Michigan
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Cystic Fibrosis
Sildenafil Exercise: Role of PDE5 Inhibition
Exercise intolerance is an understudied phenomenon in people with CF. The investigators hypothesized that vascular dysfunction plays a significant role, and can be partially reversed by administration of the phosphodiesterase…
- Trial name
- NCT04039087
- Testing
- Sildenafil 40mg oral capsule
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Jewish Health
Retinopathy of Prematurity
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP).
- Trial name
- BUTTERFLEYE (NCT04101721)
- Testing
- aflibercept, laser photocoagulation
- Where
- 52 sites in United States, Bulgaria and 11 more
- Volunteers
- 127 people
- Sponsor
- Regeneron Pharmaceuticals
Retinopathy of Prematurity
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.
- Trial name
- ROP1 (NCT02390531)
- Testing
- Bevacizumab
- Where
- 11 sites in United States
- Volunteers
- 120 people
- Sponsor
- Jaeb Center for Health Research
Retinopathy of Prematurity, Retinal Detachment
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be…
- Conditions
- Retinopathy of Prematurity, Retinal Detachment, Blindness
- Trial name
- ROP (NCT00634972)
- Testing
- ACULAR, REFRESH TEARS
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
Neonatal Abstinence Syndrome
Treatment of Neonatal Abstinence Syndrome
This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment.
- Trial name
- HOMENOW (NCT01723722)
- Testing
- Methadone, Diluted Deodorized Tincture of Opium
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Eastern Maine Medical Center
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Mucopolysaccharidoses
Carotid Structure and Function in MPS Syndromes: A Multicenter Study of the Lysosomal Disease Network
Mucopolysaccharidosis (MPS) syndromes are disorders characterized by enzyme deficiencies, and they have been linked to heart health complications.
- Trial name
- NCT01586871
- Where
- 2 sites in United States
- Volunteers
- 1,147 people
- Sponsor
- University of Minnesota
Cystic Fibrosis
Non Invasive Ventilation as Airway Clearance in Patients With Cystic Fibrosis
With the use of Non invasive ventilation the patients with cystic fibrosis will have better lung function (FEV1).
- Trial name
- NCT02083263
- Testing
- Bilevel, PEP mask
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Karolinska University Hospital
Infant Colic
Effects of Acupuncture in the Treatment of Infant Colic
Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture.
- Trial name
- NCT00907621
- Testing
- Acupuncture with Seirin 020x15 mm sterile acupuncture needle
- Where
- Norway
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Epilepsy, Benign Neonatal
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures
This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure.
- Trial name
- NCT04320940
- Testing
- Phenobarbital Sodium Injection
- Where
- 8 sites in United States, Jordan
- Volunteers
- 4 people
- Sponsor
- NEMA Research, Inc.
Plagiocephaly, Nonsynostotic
Observe the Effects of the Serkel Cranial Remolding Orthosis on Infants With Deformational Plagiocephaly
The purpose of this study is to determine the safety and effectiveness of a specific brand of cranial remolding orthosis (a custom made helmet), which is new to the United States market
- Trial name
- NCT06831513
- Testing
- Serkel 3D CRO
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Depression, Cystic Fibrosis
Pilot Trial of Phototherapy for Acute Depression in Hospitalized Cystic Fibrosis Patients
The purpose of this study is to determine whether bright light phototherapy can improve depressive symptoms in hospitalized patients with cystic fibrosis (CF) with subsequent effects on quality of life and illness recovery.
- Trial name
- PHOTO (NCT01822197)
- Testing
- Phototherapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nationwide Children's Hospital
Bronchopulmonary Dysplasia of Newborn
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary…
- Trial name
- SILDI-SAFE (NCT04447989)
- Testing
- Sildenafil
- Where
- 25 sites in United States
- Volunteers
- 125 people
- Sponsor
- Christoph Hornik
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- STRIVE (NCT00909532)
- Testing
- Ivacaftor
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 167 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Autistic Disorder
Vitamin D to Prevent Autism in Newborn Siblings
The purpose of this study is to determine whether by administering vitamin D to mothers who already have at least one child with autism and who are pregnant, that the vitamin D will prevent the recurrence of autism in the newborn…
- Trial name
- NCT01366885
- Testing
- Vitamin D3
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Oregon Health and Science University