Clinical trials: Newborn Infant
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and…
- Trial name
- NCT00297167
- Testing
- EUR-1008 (APT-1008)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Deposition of Inhaled Prolastin in Cystic Fibrosis Patients
The objective of this trial is to determine the optimal region of the lung for depositing Prolastin (alpha-1 antitrypsin; AAT) by inhalation in order to treat cystic fibrosis (CF).
- Trial name
- CF2 (NCT00486837)
- Testing
- Alpha1-Proteinase Inhibitor (Human)
- Volunteers
- 72 people
- Sponsor
- Grifols Therapeutics LLC
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) 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
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
Cystic Fibrosis
A Study to Investigate Lung Deposition of Radiolabelled OligoG
OligoG is a new potential treatment which is being developed by AlgiPharma AS (a Norwegian-based company) with an aim to help people with cystic fibrosis in the future.
- Trial name
- NCT01991028
- Testing
- Radiolabelled OligoG CF-5/20 DPI, Radiolabelled OligoG CF-5/20 6% Solution
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- BDD Pharma Ltd
Cystic Fibrosis
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
- Trial name
- NCT01746095
- Testing
- Vancomycin hydrochloride inhalation powder
- Where
- 38 sites in United States
- Volunteers
- 87 people
- Sponsor
- Savara Inc.
Alpha 1 Antitrypsin Deficiency
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.
- Trial name
- RepAIR1 (NCT07431112)
- Testing
- AIR-001 SAD dose level 1, AIR-001 SAD dose level 2, AIR-001 SAD dose level 3
- Where
- 13 sites in Australia, Georgia and 7 more
- Volunteers
- 54 people
- Sponsor
- AIRNA 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.
Candidiasis, Invasive
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants.
- Trial name
- NCT01945281
- Testing
- Caspofungin, Amphotericin B Deoxycholate
- Volunteers
- 51 people
- Sponsor
- Merck Sharp & Dohme LLC
Persistent Pulmonary Hypertension of Newborn
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).
- Trial name
- NEPHY (NCT06499363)
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- Ferrer Internacional S.A.
Cystic Fibrosis
Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.
- Trial name
- NCT02015663
- Testing
- Tobramycin Inhalation Powder
- Where
- 21 sites in United States
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Hyalinosis, Hyaline Membrane Disease
Biomarker for Hyaline Fibromatosis Syndrome (BioHFS)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Hyaline fibromatosis syndrome from the blood
- Conditions
- Hyalinosis, Hyaline Membrane Disease, Juvenile Hyaline Fibromatosis, Fibromatosis Hyalinica Multiplex Juvenilis
- Trial name
- BioHFS (NCT03196115)
- Where
- 3 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Infant Colic
Lactocare Baby Drops in Infants Colic
The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC.
- Trial name
- LACONIC (NCT02839239)
- Testing
- Drops with lactobacilli and vitamin D3, Drops with vitamin D3
- Volunteers
- 168 people
- Sponsor
- Biocare Copenhagen A/S
Healthy
Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections…
- Trial name
- NCT05303077
- Testing
- Nutribén Innova® 1, Nutribén®, Breastfeed
- Where
- 21 sites in Spain
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Alter Farmacia, S.A.
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Cystic Fibrosis
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the…
- Trial name
- SNO-6 (NCT02589236)
- Testing
- Cavosonstat
- Where
- 46 sites in United States
- Volunteers
- 138 people
- Sponsor
- Nivalis Therapeutics, Inc.
Tolerance
Safety of Lactobacillus Fermentum in Newborn Infants
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk.
- Trial name
- NCT01346644
- Testing
- Infant formula
- Where
- Spain
- Volunteers
- 137 people
- Sponsor
- Puleva Biotech
Cystic Fibrosis
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.
- Trial name
- NCT01460836
- Testing
- Tobramycin solution for inhalation, Aztreonam lysine for inhalation
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
- Trial name
- NCT01899105
- Testing
- lumacaftor, ivacaftor
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated