Clinical trials: Infants
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Intestinal Absorption
Comparative A1 vs A2 Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant
This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion.
- Trial name
- NCT03081936
- Testing
- Oral consumption of Nutricia Aptamil Stage 1 formula, Oral consumption of a2® Platinum Stage 1 formula, Oral consumption of breast milk
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- a2 Milk Company Ltd.
Jaundice, Neonatal
Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.
- Trial name
- NCT06372093
- Testing
- Picterus Jaundice Pro
- Where
- Botswana
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Picterus AS
Protein Sensitive Colitis
Infants With Protein Sensitive Colitis
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
- Trial name
- NCT01813526
- Testing
- Experimental Infant Formula
- Where
- 2 sites in United States
- Volunteers
- 53 people
- Sponsor
- Abbott Nutrition
Persistent Infection, Cystic Fibrosis
A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis
CMTX-101 is a bacterial biofilm disrupting monoclonal antibody being developed as an adjunctive therapy to standard of care antibiotics.
- Trial name
- NCT06159725
- Testing
- CMTX-101
- Where
- 23 sites in United States
- Volunteers
- 43 people
- Sponsor
- Clarametyx Biosciences, Inc.
Retinopathy of Prematurity (ROP)
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
- Trial name
- NCT01096784
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 24 sites in United States, Italy and 4 more
- Volunteers
- 121 people
- Sponsor
- Shire
Diphtheria, Polio
Safety and Immune Response of Different Pediatric Combination Vaccines.
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a…
- Conditions
- Diphtheria, Polio, Pertussis
- Trial name
- NCT00255047
- Testing
- DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined, DTaP-IPV and ActHIB®
- Where
- 36 sites in United States
- Volunteers
- 2,167 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cystic Fibrosis, CFTR Gene Mutation
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor…
- Trial name
- LunairCF (NCT06747858)
- Testing
- ARCT-032
- Where
- 13 sites in United States
- Volunteers
- 33 people
- Sponsor
- Arcturus Therapeutics, Inc.
Cystic Fibrosis
Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients
Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo control arm.
- Trial name
- NCT02498535
- Testing
- Nitric Oxide 160 ppm
- Where
- 7 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Novoteris, LLC
Hunter Syndrome
A Study of GC1111 in Hunter Syndrom Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Trial name
- NCT03920540
- Testing
- GC1111, Comparator
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Green Cross Corporation
Lung Ultrasound, Respiratory Distress Syndrome, Newborn
Bedside Ultrasound to Monitor Lung Function and Blood Flow in Newborns Treated With Surfactant
The ULISSES study looks at how doctors use bedside ultrasound to help treat premature babies with breathing problems caused by Respiratory Distress Syndrome (RDS).
- Trial name
- ULISSES (NCT07070167)
- Testing
- Intratracheal administration of surfactant
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Chiesi Poland Sp. z o.o.
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Multiple Sclerosis, Clinically Isolated Syndrome
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of…
- Trial name
- MINORE (NCT04998812)
- Testing
- Ocrelizumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
Diaper Rash
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.
- Trial name
- NCT00702507
- Testing
- 0.25 % Miconazole Nitrate Ointment
- Where
- 8 sites in United States, Dominican Republic and 2 more
- Volunteers
- 200 people
- Sponsor
- Stiefel, a GSK Company
Multiple Sclerosis, Pregnancy
Kesimpta (Ofatumumab) Pregnancy Registry
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
- Trial name
- NCT05634967
- Testing
- Kesimpta
- Where
- United States
- Volunteers
- 725 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease
- Trial name
- NCT00425165
- Testing
- denufosol tetrasodium (INS37217) Inhalation Solution
- Volunteers
- 6 people
- Sponsor
- Merck Sharp & Dohme LLC
Atopic Dermatitis
Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects
This study is not being conducted in the United States. To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".
- Trial name
- NCT00139581
- Testing
- Pimecrolimus
- Where
- Switzerland
- Sponsor
- Novartis
Cystic Fibrosis, Pancreatic Insufficiency
Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis…
- Trial name
- NCT00432861
- Testing
- PANCRECARB® (pancrelipase)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Digestive Care, Inc.
Chronic Idiopathic Constipation (CIC)
Post-Marketing Study of Prucalopride Safety In Pregnancy
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride.
- Trial name
- NCT04869280
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Takeda
Ductus Arteriosus, Patent
Paracetamol in Patent Ductus Arteriosus
The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT02422966
- Testing
- Paracetamol, Ibuprofen
- Where
- 5 sites in Italy
- Volunteers
- 110 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A