Clinical trials: Newborn Infant
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
Nursing Caries, Newborn
The Effect of the Mobile Application Developed for the Care of Sick Newborns
The goal of this randomize controlled trial determine the effect of the mobile application developed for the care of sick newborns in the Neonatal Intensive Care Unit on nurses' perception of nursing diagnoses and care that…
- Trial name
- NCT05776615
- Testing
- mobile application
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Kutahya Health Sciences University
Neonatal Abstinence Syndrome
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared…
- Trial name
- NCT03762317
- Testing
- Clonidine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hennepin County Medical Center, Minneapolis
Cystic Fibrosis
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del…
- Trial name
- NCT04353817
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 34 sites in Australia, Canada and 8 more
- Volunteers
- 121 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
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
Herpes Simplex
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM).
- Trial name
- NCT00031447
- Testing
- Acyclovir
- Where
- 28 sites in United States, Canada
- Volunteers
- 29 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Imaging Airway Liquid Absorption in Cystic Fibrosis
The investigators are developing a new nuclear medicine imaging technique for measuring liquid absorption in the airways that can be applied to screen new medications being developed to treat cystic fibrosis (CF).
- Trial name
- NCT01486199
- Testing
- Absorptive clearance scan
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Lactose Intolerance
HYBRID: Hydrogen Breath Test in Lactose Digestion
The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
- Trial name
- HYBRID (NCT02703987)
- Testing
- Fermented infant milk formula, Non-fermented infant milk formula
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Cystic Fibrosis, Pancreatic Insufficiency
Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)
Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic…
- Trial name
- NCT00880100
- Testing
- Ultrase® MT12
- Where
- 15 sites in United States
- Volunteers
- 49 people
- Sponsor
- Forest Laboratories
Preterm Infants
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit…
- Trial name
- NCT03370757
- Testing
- 3-hour bundled care, 6-hour bundled care
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke University
Transient Tachypnea of the Newborn
High Flow Nasal Cannula Versus Bubble Nasal CPAP for the Treatment of Transient Tachypnea of the Newborn in Infants ≥ 35 Weeks Gestation
The primary objective is to determine whether High Flow Nasal Cannula (HFNC) is a superior respiratory modality for neonates ≥36 weeks with transient tachypnea of the newborn (TTN) when compared to the standard of care modality…
- Trial name
- NCT01270581
- Testing
- High Flow Nasal Cannula, Bubble Nasal CPAP
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Neonatal Abstinence Syndrome
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).
- Trial name
- NCT03670160
- Testing
- Phenobarbital, Clonidine
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Tennessee Medical Center
Preterm Infants
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements.
- Trial name
- NCT01235923
- Testing
- three times weekly Epo, weekly Epo
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of New Mexico
Neonatal Abstinence Syndrome
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units.
- Trial name
- NCT01360450
- Testing
- Clonidine HCL, saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University
Magnetic Resonance Imaging
DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.
- Trial name
- NCT02411201
- Testing
- DOTAREM
- Where
- 9 sites in Austria, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Guerbet
Cystic Fibrosis
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
- Trial name
- KONDUCT (NCT01614457)
- Testing
- Ivacaftor
- Where
- 31 sites in United States, United Kingdom
- Volunteers
- 70 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Severe Combined Immunodeficiency Disease, Severe Primary Immunodeficiency Disorder
Allogeneic SCT Of Pts With SCID And Other Primary Immunodeficiency Disorders
This study is to discover whether children with severe combined immunodeficiency disease (SCID) or other primary immunodeficiency disorder (PID) for which no satisfactory treatment other than stem cell transplantation (SCT)…
- Conditions
- Severe Combined Immunodeficiency Disease, Severe Primary Immunodeficiency Disorder, Undefined T Cell Deficiency Disorder, Wiskott-Aldrick Syndrome
- Trial name
- MASCI (NCT00579137)
- Testing
- Campath -1H, Fludarabine, Anti-CD45
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.