Clinical trials: Surfactant, open to volunteers
Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS)
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP).
- Conditions
- Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy, Surfactant
- Trial name
- NEU-VODEtec (NCT06758492)
- Testing
- Video laryngoscopy used to insert thin endotracheal catheter, Direct laryngoscopy used to insert thin endotracheal catheter
- Where
- 16 sites in Croatia, Czechia and 7 more
- Volunteers
- 600 people
- Sponsor
- University College Dublin
Respiratory Distress Syndrome
Non Inferiority Trial Investigating Surfactants Administered Via MIST
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome.
- Trial name
- Niftisurf (NCT06074380)
- Testing
- MIST surfactant
- Where
- United States
- Volunteers
- 262 people
- Sponsor
- Endeavor Health
Respiratory Distress Syndrome in Premature Infant
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will…
- Trial name
- REMEDIES (NCT05791331)
- Testing
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Respiratory Distress Syndrome, Newborn, Premature Birth
Prophylactic Minimally Invasive Surfactant Evaluation
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation…
- Trial name
- PreProMISe (NCT06007547)
- Testing
- Poractant Alfa
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal)
Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study
The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Respiratory Distress Syndrome of Newborn
- Trial name
- NCT07550218
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Vastra Gotaland Region
Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants, Intensive Care Units, Neonatal
- Trial name
- NCT06446453
- Testing
- Echography-guided Surfactant THERapy (ESTHER)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Connecticut Children's Medical Center
Neonates and Preterm Infants, Infant Respiratory Distress Syndrome
Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA)…
- Conditions
- Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Surfactant
- Trial name
- SurfStab I (NCT07261787)
- Testing
- Poractant alfa (Curosurf®) - 1-minute administration, Poractant alfa (Curosurf®) - 5-minute administration
- Where
- Austria
- Volunteers
- 76 people
- Sponsor
- Medical University of Graz
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Little Lungs Study
This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
- Trial name
- NCT06855043
- Testing
- Calfactant, Budesonide
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- University of Wisconsin, Madison
Infant, Newborn, Diseases, Prematurity
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of…
- Conditions
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
- Trial name
- proTeCt (NCT06557551)
- Testing
- Thin catheter surfactant
- Where
- Ireland
- Volunteers
- 164 people
- Sponsor
- University College Dublin
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Neonatology
EXTERNAL NEGATIVE PRESSURE DURING LISA
The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm…
- Trial name
- ENCP LISA (NCT07271368)
- Testing
- ENCP
- Where
- Czechia
- Volunteers
- 25 people
- Sponsor
- Charles University, Czech Republic
Respiratory Distress Syndrome, Newborn
LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
This prospective, non-randomized, unblinded pilot study evaluates and compares the intrapulmonary distribution of exogenous surfactant in preterm neonates when administered via Less Invasive Surfactant Administration (LISA)…
- Trial name
- LISA-Ven-LUS (NCT07514481)
- Testing
- surfactant administration by ETT, surfactant administration by thin catheter
- Where
- Qatar
- Volunteers
- 22 people
- Sponsor
- Hamad General Hospital
Surfactant Deficiency Syndrome Neonatal
deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants
Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant…
- Trial name
- deMISTify (NCT07522346)
- Testing
- Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy, Control (Minimally Invasive Surfactant Therapy)
- Where
- Australia
- Volunteers
- 36 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Distress Syndrome (Neonatal), Surfactant Deficiency Syndrome Neonatal
Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration
Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs.
- Trial name
- VID LISA (NCT07426016)
- Testing
- Video Laryngoscopy, Direct Laryngoscopy
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Texas Southwestern Medical Center
Familial Pulmonary Fibrosis
GEN-FPF: Genetic Exploration of Familial Pulmonary Fibrosis
Pulmonary fibrosis (PF) is a progressive lung disease marked by tissue scarring and impaired breathing. Familial pulmonary fibrosis (FPF) makes up 10-20% of PF cases and shares features with idiopathic PF (IPF), but the genetic…
- Trial name
- GEN-FPF (NCT07251725)
- Where
- Italy
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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.
Surfactant, Respiratory Distress Syndrome (Neonatal)
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better.
- Trial name
- SALTI (NCT07030270)
- Testing
- Surfactant Administration through Laryngeal or Supraglottic Airway, Surfactant Administration through Thin Catheter
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
Interstitial Lung Disease
Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants
Scientific justification : Variants in surfactant-related genes (SRG) explain approximately 6% of familial pulmonary fibrosis (FPF).
- Trial name
- TIPS (NCT07443436)
- Testing
- Azithromycin 250 mg x3/week (3 tablets/week), Prednisone 10 mg/day, Hydroxychloroquine 400 mg/day
- Where
- 3 sites in France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Respiratory Distress Syndrome, Pre-term Infants
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham).
- Trial name
- NCT06776783
- Testing
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system), Control
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Aerogen Pharma Limited