Clinical trials: Newborn Infant
Cystic Fibrosis-related Diabetes, Cystic Fibrosis
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients…
- Trial name
- NCT06149793
- Testing
- Empagliflozin
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Minnesota
Cystic Fibrosis
The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.
- Trial name
- GROW (NCT03020719)
- Testing
- Oral Glutathione
- Where
- 18 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Minnesota
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
Infection
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
- Trial name
- NCT03728608
- Testing
- Feeding tube dwell time of 48 hours, Feeding tube dwell time of 7 day
- Where
- United States
- Volunteers
- 151 people
- Sponsor
- University of Florida
Opioid-Related Disorders, NAS
MOms in REcovery (MORE) Study: Defining Optimal Care
Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with…
- Conditions
- Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
- Trial name
- MORE (NCT04251208)
- Testing
- Observational Study
- Where
- 10 sites in United States
- Volunteers
- 2,510 people
- Sponsor
- Trustees of Dartmouth College
Neonatal Opioid Withdrawal Syndrome
Use of SVS Device to Improve Outcomes for Neonatal Opioid Withdrawal Syndrome.
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS).
- Trial name
- NCT04834297
- Testing
- Prapela SVS mattress
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Tufts Medical Center
Retinopathy of Prematurity
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Phase 2, open-label, randomized, multi-center studies in infants and premature infants are necessary to determine treatment and preventative strategies for ROP.
- Trial name
- SPIPROP (NCT02344225)
- Testing
- Caffeine citrate, Ibuprofen, Ketorolac
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- State University of New York - Downstate Medical Center
Cystic Fibrosis
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.
- Trial name
- NCT02310789
- Testing
- Ivacaftor, β-Adrenergic cocktail, Pilocarpine Nitrate 5%
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Richard Barry Moss
Birth Asphyxia
Umbilical Cord Milking in Non-Vigorous Infants
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for…
- Trial name
- MINVI (NCT03631940)
- Testing
- Umbilical Cord Milking, Early Cord Clamping
- Where
- 10 sites in United States, Canada and 1 more
- Volunteers
- 1,730 people
- Sponsor
- Sharp HealthCare
Cystic Fibrosis
Ketone Supplementation in Cystic Fibrosis
This study will examine the effects of a novel ketone monester supplement on patients with cystic fibrosis experiencing an acute pulmonary exacerbation requiring hospitalization.
- Trial name
- NCT04938726
- Testing
- Ketone Monoester
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis
Electro Flo 5000 and Vest Therapy
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to…
- Trial name
- EF/Vest (NCT02277626)
- Testing
- Electro Flo 5000, Incourage Vest System
- Volunteers
- 15 people
- Sponsor
- Stanford University
Lysosomal Storage Disease, Peroxisomal Disorder
Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders
This study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) in patients with high-risk lysosomal and peroxisomal disorders using a novel…
- Trial name
- NCT01626092
- Testing
- Campath-1H, Clofarabine, Melphalan
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Trial name
- NCT00362609
- Testing
- pantoprazole
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Eczema
Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.
- Trial name
- NCT02404493
- Testing
- EpiCeram Skin Barrier Emulsion, 1% Colloidal Oatmeal Balm
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Hyperbilirubinemia, Neonatal
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
It is a normal process in the human body for red blood cells to die, which makes bilirubin. Bilirubin is cleared away through the liver.
- Trial name
- NCT00850993
- Testing
- Stannsoporfin, PhotoTherapy (as needed)
- Where
- 23 sites in United States, Poland and 2 more
- Volunteers
- 58 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Resuscitation, Neonatal Prematurity
Monitoring Neonatal Resuscitation Trial
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV)…
- Conditions
- Resuscitation, Neonatal Prematurity, Positive-Pressure Respiration
- Trial name
- MONITOR (NCT03256578)
- Testing
- New Life Box Respiratory Function Monitor
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- University of Pennsylvania
Prematurity, Very Low Birth Weight
The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.
- Trial name
- NCT00593684
- Testing
- Silver Alginate
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
Cystic Fibrosis
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance…
- Trial name
- NCT02516410
- Testing
- VX-661 plus ivacaftor combination, Ivacaftor
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 168 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
Adrenoleukodystrophy, Metachromatic Leukodystrophy
HSCT for High Risk Inherited Inborn Errors
Hematopoietic stem cell transplantation has proven effective therapy for individuals with adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD, or Krabbe disease).
- Conditions
- Adrenoleukodystrophy, Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, Tay Sachs Disease
- Trial name
- NCT00383448
- Testing
- Clofarabine, Total body Irradiation, Melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota