Clinical trials: Neonatal Apnea
BPD - Bronchopulmonary Dysplasia, Apnea of Prematurity
Early Caffeine in Preterm Neonates
This is a clinical trial which will investigate whether administration of caffeine, a respiratory stimulant, to preterm babies soon after birth can prevent the need for a breathing tube, or intubation.
- Conditions
- BPD - Bronchopulmonary Dysplasia, Apnea of Prematurity, Hemodynamic Instability, Intubation
- Trial name
- NCT03086473
- Testing
- Caffeine Citrate
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Jennifer Shepherd
Obstructive Sleep Apnea, Hypertonia, Muscle
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
- Conditions
- Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance
- Trial name
- NCT05527652
- Testing
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis
European Home Mechanical Ventilation Registry
The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation of HMV by documenting the characteristics of HMV patients and their treatment.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Amyotrophic Lateral Sclerosis, Spinal Cord Injury, Muscular Dystrophies
- Trial name
- EHMVR (NCT02315339)
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Patent Foramen Ovale
Close Obstructive Sleep Apnea (OSA) Trial
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
- Trial name
- NCT06113562
- Testing
- PFO closure
- Sponsor
- University of Miami
Difficult Airway, Difficult Airway Intubation
SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety.
- Conditions
- Difficult Airway, Difficult Airway Intubation, Neonate
- Trial name
- SEALION (NCT06683599)
- Testing
- Apneic oxygenation
- Where
- 4 sites in Australia, Brazil and 2 more
- Volunteers
- 240 people
- Sponsor
- Vinícius C Quintão, MD, MSc, PhD
Apnea of Prematurity, Respiratory Insufficiency
Doxapram Therapy in Preterm Infants (DOXA Trial)
Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system.
- Trial name
- NCT04430790
- Testing
- Doxapram
- Where
- 24 sites in Belgium, Canada and 1 more
- Volunteers
- 396 people
- Sponsor
- Erasmus Medical Center
Obstructive Sleep Apnea
Optimizing the Management of OSA in Children With Down Syndrome
The objective of this retrospective descriptive study is to assess current practices for the screening and surgical treatment of OSA in children with Down syndrome at the Strasbourg University Hospital and to disseminate a…
- Trial name
- SAOS-21 (NCT07334444)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Strasbourg, France
Obstructive Sleep Apnea of Child
Surgical Treatment of Children With OSA and Small Tonsils or Down Syndrome
The purpose of this study is to prospectively compare the effectiveness of a novel personalized approach to the surgical treatment of obstructive sleep apnea (OSA) in children, drug induced sleep endoscopy (DISE) directed surgery…
- Trial name
- NCT05154214
- Testing
- Adenotonsillectomy, Drug-induced sleep endoscopy directed surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Oregon Health and Science University
Asthma, Atrial Fibrillation
Improving Quality by Maintaining Accurate Problems in the EHR
The overall goal of the IQ-MAPLE project is to improve the quality of care provided to patients with several heart, lung and blood conditions by facilitating more accurate and complete problem list documentation.
- Conditions
- Asthma, Atrial Fibrillation, Chronic Obstructive Pulmonary Disease, Coronary Artery Disease
- Trial name
- IQ-MAPLE (NCT02596087)
- Testing
- Problem List Suggestion
- Where
- 4 sites in United States
- Volunteers
- 2,386 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
OSAHS, Craniofacial Abnormalities
Upper-airway Changes After Bimaxillary Advancement in OSAHS
One of the most effective surgical treatments for obstructive sleep apnoea / hypopnoea syndrome (SAHS) with global impact on the upper-airway (UA) is the maxilla-mandibular advancement (MMA).
- Trial name
- OSAHS (NCT04301635)
- Testing
- Maxillo-mandibular Advancement + Counterclockwise rotation
- Where
- Spain
- Volunteers
- 38 people
- Sponsor
- Hospital de Cruces
Dilated Cardiomyopathy
BiPAP for Cardiomyopathy With Central Sleep Apnea
We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.
- Trial name
- NCT00282789
- Testing
- bilevel positive airway pressure, bilevel positive airway pressure (Device)
- Where
- Japan
- Sponsor
- Nagoya University
Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV
Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery…
- Trial name
- Bio-NAVA (NCT02860325)
- Testing
- NIV-NAVA, Conventional
- Where
- Spain
- Volunteers
- 56 people
- Sponsor
- Complejo Hospitalario Universitario Insular Materno Infantil
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.
Apnea of Newborn, Preterm Labor
Analyze Changes in Respiratory Rate When Using the Scare Respirator
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare…
- Trial name
- RESPSUS (NCT04584814)
- Testing
- without any device, scare ventilator at 20, scare ventilator at 40
- Where
- Chile
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Neonatal Apnea, Infants
Caffeine Optimization for Oxygen Saturation Index in ELBW Infants
The goal of this clinical trial is to determine whether a higher dose of caffeine citrate can improve breathing and reduce health complications in extremely premature infants, specifically those born before 28 weeks of pregnancy…
- Trial name
- COFIE trail (NCT07216365)
- Testing
- Caffeine Citrate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Rochester
Infant, Premature, Intubation, Intratracheal
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen…
- Conditions
- Infant, Premature, Intubation, Intratracheal, Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
- Trial name
- NEORIN (NCT07650552)
- Testing
- Rocuronium Bromide 10 MG/ML, Fentanyl 1 mcg/kg IV, single dose, administered before non-emergent tracheal intubation.
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- UEA - Universidade Do Estado Do Amazonas
Retinopathy of Prematurity, Pain
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination…
- Conditions
- Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
- Trial name
- MASK-ROP (NCT03824782)
- Testing
- Phototherapy Mask
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- Sunnybrook Health Sciences Centre
Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
Pediatric Down Syndrome Post-Approval Study
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea.
- Trial name
- NCT06851338
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Sudden Unexplained Infant Death, Apnea of Newborn
Advanced Wireless Sensors for Neonatal Care in the Delivery Room
The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age).
- Conditions
- Sudden Unexplained Infant Death, Apnea of Newborn, Newborn Morbidity, Newborn Asphyxia
- Trial name
- AWARD (NCT06693817)
- Testing
- Wireless skin sensors vital sign monitoring system, Wired vital sign monitoring system
- Where
- 5 sites in Brazil, Canada and 2 more
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Guilherme Sant'Anna, MD
Gastroesophageal Reflux, Apnea
Study of Erythromycin in GER-Associated Apnea of the Newborn
To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective…
- Conditions
- Gastroesophageal Reflux, Apnea, Bradycardia
- Trial name
- SEGAN (NCT01825473)
- Testing
- Erythromycin, Multi-channel intra-luminal impedance (MII) pH monitoring
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Virginia