Clinical trials: Respiratory Control in Premature Infants
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study
Many babies born very preterm (<32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs.
- Trial name
- PrePAP (NCT07251790)
- Testing
- Pre-extubation continuous positive airway pressure
- Where
- 3 sites in Australia
- Volunteers
- 134 people
- Sponsor
- Murdoch Childrens Research Institute
Respiratory Distress Syndrome, Hyaline Membrane Disease
Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS
The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation…
- Trial name
- NCT02482766
- Testing
- Poractant alfa, 200 mg/kg, Ventilator for High-frequency Oscillatory Ventilation (HFOV), Nasal Continuous Positive Airway Pressure (nCPAP)
- Where
- 33 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Catholic University of the Sacred Heart
Premature Infant Disease, Apnea of Prematurity
Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia
The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital.
- Conditions
- Premature Infant Disease, Apnea of Prematurity, Development, Infant
- Trial name
- NCT06518603
- Testing
- Caffeine citrate 20mg/kg/day
- Where
- Zambia
- Volunteers
- 340 people
- Sponsor
- University of Alabama at Birmingham
Apnea of Prematurity, Intermittent Hypoxemia
The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
- Trial name
- NCT05298748
- Testing
- Womb sound recordings
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Case Western Reserve University
Tracheomalacia, Bronchopulmonary Dysplasia (BPD)
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention
Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life.
- Conditions
- Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring, Cystic Lung Disease
- Trial name
- TRALULALA-AZI (NCT06409299)
- Testing
- Azithromycin 40 MG/ML
- Volunteers
- 150 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Respiratory Distress Syndrome in Preterm Infants
LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown.
- Trial name
- NCT05388175
- Testing
- Rigid catheter, Soft catheter
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates
This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD.
- Trial name
- NCT05071638
- Testing
- autologous cord blood mononuclear cells
- Where
- 2 sites in China
- Volunteers
- 76 people
- Sponsor
- Guangdong Women and Children Hospital
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity
- Trial name
- NCT00308789
- Testing
- Biphasic Infant flow NCPAP, CPAP
- Where
- Canada
- Volunteers
- 136 people
- Sponsor
- Mount Sinai Hospital, Canada
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
Motor Delay, Premature Birth
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
Study Aims Pilot study: Due to the large recruitment goal and length of the project, the study team/PIs will evaluate the first cohort of 6-10 participants to refine study procedures and study-related materials.
- Conditions
- Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT05568264
- Testing
- Physical Therapy intervention
- Where
- 3 sites in United States
- Volunteers
- 222 people
- Sponsor
- Shirley Ryan AbilityLab
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death.
- Trial name
- NCT04440670
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- 2 sites in China
- Volunteers
- 140 people
- Sponsor
- Guangdong Women and Children Hospital
Bronchopulmonary Dysplasia
p16Ink4a in Bronchopulmonary Dysplasia in Children
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure.
- Trial name
- DBP16 (NCT03540680)
- Testing
- Blood punction
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Respiratory Distress Syndrome, Newborn
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies…
- Trial name
- Curpap (NCT00501982)
- Testing
- Poractant alfa (Curosurf®)
- Where
- 5 sites in Czechia, France and 3 more
- Volunteers
- 208 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Comparison of INRECSURE and LISA in Preterm Neonates With RDS
The primary hypothesis of this study is that surfactant administration by INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E), via a high frequency oscillatory ventilation recruitment maneuver increases survival without BPD at 36…
- Trial name
- INRECLISA (NCT05711966)
- Testing
- Ventilator for High-frequency Oscillatory Ventilation (HFOV), Less invasive surfactant administration (LISA)
- Where
- Italy
- Volunteers
- 381 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Infant, Premature, Bronchopulmonary Dysplasia (BPD)
Dexamethasone Regimens for BPD Prevention in Preterm Infants
The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia…
- Trial name
- NCT07052201
- Testing
- Dexamethasone. Dart, Dexametasone. Medium
- Where
- 24 sites in China
- Volunteers
- 970 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Respiratory Distress Syndrome, Newborn
Fluid Restriction in Respiratory Distress of the Newborn
The object of this study is to determine the best way to care for infants with respiratory distress. The investigators are testing a method of feeding fluids to infants with respiratory distress in amounts similar to what healthy…
- Trial name
- NCT03120585
- Testing
- Fluid Management Intervention
- Where
- 2 sites in United States
- Volunteers
- 65 people
- Sponsor
- University of Oklahoma
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Complication Due to Immunization
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
- Trial name
- NCT02726178
- Testing
- Advil® Pediatric drops for infants
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Bronchopulmonary Dysplasia
TINN2: Treat Infection in NeoNates 2
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
- Trial name
- TINN2 (NCT02282176)
- Testing
- Azithromycin
- Where
- 16 sites in Belgium, France and 7 more
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France