Clinical trials: Newborn Infant
Clubfoot
A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot…
- Trial name
- NCT02395185
- Testing
- Milk bottle administration, Water bottle administration, Sucrose bottle administration
- Volunteers
- 33 people
- Sponsor
- Shriners Hospitals for Children
Cystic Fibrosis, Healthy
Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis
Our aims were to determine if exhaled breath condensate (EBC) could detect differences in ion regulation between cystic fibrosis (CF) and healthy and measure the effect of the albuterol on EBC ions in these populations.
- Trial name
- NCT01880723
- Testing
- Albuterol
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Arizona
HIV Infections
Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants
The purpose of this study was to determine the washout pharmacokinetics (PK) and safety of in utero/intrapartum exposure to maternal raltegravir (RAL) in infants born to pregnant women with HIV infection who received RAL 400 mg…
- Trial name
- NCT01828073
- Testing
- Raltegravir
- Where
- 19 sites in United States, Brazil and 3 more
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients
The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized.
- Trial name
- DOXY (NCT01112059)
- Testing
- Doxycycline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del…
- Trial name
- NCT03525574
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 110 sites in United States, Australia and 11 more
- Volunteers
- 507 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Bronchopulmonary Dysplasia (BPD)
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
- Trial name
- SASSIE (NCT02907593)
- Testing
- Budesonide in Calfactant
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cynthia McEvoy
Acute Kidney Injury, Hypoxia-Ischemia, Brain
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease.
- Conditions
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia
- Trial name
- NCT03941015
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Beijing Anzhen Hospital
Inadequate; Pulmonary Ventilation, Newborn, Infant, Very Low Birth Weight
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely.
- Trial name
- NCT01785563
- Testing
- Nasal NIV-NAVA
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tarah T Colaizy
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Irritable Bowel Syndrome Constipation Predominant
Effects of ROSE-010 on GI Transit in Constipation Predominant Irritable Bowel Syndrome (C-IBS) Patients
This trial will study the effects of an investigational (not FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females with constipation predominant irritable bowel…
- Trial name
- NCT01056107
- Testing
- ROSE-010
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Mayo Clinic
Cystic Fibrosis
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for…
- Trial name
- NCT03559062
- Testing
- TEZ/IVA, IVA
- Where
- 27 sites in Australia, Belgium and 7 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
This study will provide important mechanistic information regarding the effect of inhaled mannitol (Bronchitol) in people with cystic fibrosis (PwCF) with moderate to severe disease who are already using…
- Trial name
- NCT05740618
- Testing
- Mannitol Inhalant Product
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of North Carolina, Chapel Hill
Atopic Dermatitis (AD)
Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.
- Trial name
- NCT02357940
- Testing
- Experimental Product
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and…
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs (NCT03918850)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- T. John Winhusen, PhD
Cystic Fibrosis
Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt…
- Trial name
- NCT00928135
- Testing
- Xylitol, Hypertonic saline
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Joseph Zabner
Seizures, Disorder of Fetus or Newborn
Pharmacokinetic and Safety Trial of Intravenous Levetiracetam in the Treatment of Neonatal Seizures
The hypothesis is that a loading dose of 20 mg/kg and a maintenance dose of 5 mg/kg of Levetiracetam is going to be safe and effective in the treatment of seizures in neonates.
- Trial name
- Keppra (NCT00884052)
- Testing
- Low dose levetiracetam, High dose levetiracetam
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Richard H. Haas
Netherton Syndrome
Natural History of Netherton Syndrome
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).
- Trial name
- NCT05902663
- Where
- 4 sites in United States, Italy
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
GERD
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
- Trial name
- NCT00427635
- Testing
- Esomeprazole
- Where
- 3 sites in Australia, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Infections
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
The purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns.
- Trial name
- PEPNI (NCT03614676)
- Testing
- Blood sample collection, Cord blood sample collection, Maternal Diary Card
- Where
- 40 sites in Argentina, Bangladesh and 8 more
- Volunteers
- 4,493 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis, Anemia, Iron-Deficiency
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.
- Trial name
- NCT01755455
- Testing
- Ferrous sulfate 325mg
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Dartmouth-Hitchcock Medical Center