Clinical trials: Infant, Newborn
Obesity, Induction of Labor Affected Fetus / Newborn
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI).
- Trial name
- APPOINT (NCT03801252)
- Testing
- Cefazolin, Azithromycin
- Where
- United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Premature Infants
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management…
- Trial name
- NCT01994954
- Testing
- RHO
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- University of Massachusetts, Worcester
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
Premature Birth of Newborn, Intervention Studies
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
- Trial name
- NCT02508571
- Testing
- Direct swallowing training (DST), Oral sensorimotor stimulation (OSMS)
- Where
- South Korea
- Volunteers
- 189 people
- Sponsor
- Seoul National University Hospital
Cystic Fibrosis
Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation
The purpose of this study is to provide information regarding the long-term safety and pharmacodynamics of ivacaftor treatment in the pediatric population younger than 6 years of age with Cystic Fibrosis (CF) who have a CFTR…
- Trial name
- NCT01946412
- Testing
- Ivacaftor
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 33 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pancreatic Exocrine Insufficiency
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
- Trial name
- NCT01747330
- Testing
- Pancreatin
- Where
- 9 sites in Russia
- Volunteers
- 40 people
- Sponsor
- Abbott Products
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Cystic Fibrosis
Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis
This is a prospective, multicenter, observational study designed to collect gastrointestinal related data in patients with Cystic Fibrosis (CF).
- Trial name
- GALAXY (NCT03801993)
- Where
- 26 sites in United States
- Volunteers
- 402 people
- Sponsor
- Chris Goss
Corona Virus Infection, Pregnancy Related
Understanding COVID-19 Infection in Pregnant Women and Their Babies
This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.
- Conditions
- Corona Virus Infection, Pregnancy Related, Neonatal Infection, Breastfeeding
- Trial name
- periCOVID (NCT04703270)
- Where
- United Kingdom
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Cystic Fibrosis
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
- Trial name
- NCT02514473
- Testing
- VX-809, VX-770
- Where
- 53 sites in United States, Australia and 7 more
- Volunteers
- 206 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia
Relationship Between EIT and Respiratory Status in Very Preterm Infants
Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in…
- Conditions
- Chronic Lung Disease of Prematurity, Bronchopulmonary Dysplasia, Premature Lungs
- Trial name
- NCT06609135
- Testing
- Sentec LuMon Device (EIT system), Sentec Digital Monitoring System (transcutaneous CO2 monitor)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Lawrence Rhein
Severe Combined Immunodeficiency
MND-ADA Transduction of CD34+ Cells From Children With ADA-SCID
Severe combined immune deficiency (SCID) may result from inherited deficiency of the enzyme adenosine deaminase (ADA). Children with ADA-deficient SCID often die from infections in infancy, unless treated with either a bone…
- Trial name
- NCT00794508
- Testing
- ADA gene transfer
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Donald B. Kohn, M.D.
Cystic Fibrosis, Irritable Bowel Syndrome
Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel…
- Conditions
- Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
- Trial name
- NCT05515250
- Testing
- Use of neurostimulation device
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- St. Louis University
Congenital Heart Disease
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
Each year, there are over 400,000 cardiac surgical operations performed in the United States; of which 10,000 are performed on children.
- Trial name
- NCT00585013
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Washington University School of Medicine
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Resuscitation
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room…
- Trial name
- NCT00443118
- Testing
- T-piece resuscitator Neopuff TM, Self Inflating Bag with PEEP, Self Inflating Bag without PEEP
- Where
- 11 sites in United States, Argentina and 3 more
- Volunteers
- 1,032 people
- Sponsor
- Edgardo Szyld
Cystic Fibrosis
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
- Trial name
- NCT03911713
- Testing
- VX-561, IVA
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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)
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Cystic Fibrosis
Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from…
- Trial name
- NCT01983787
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- University of Aarhus