Clinical trials: Apnea of Newborn, active
Apnea of Prematurity
MICropsampling for CAffeine in PREMature Newborns
Caffeine is one of the top five most prescribed drugs in neonatology. Caffeine has many beneficial impacts on preterm infants (cardiac, neurologic and pulmonary). One of these beneficial impacts is to prevent apnea.
- Trial name
- MICCAPREM (NCT07779915)
- Testing
- collection of an extra drop of capillary blood
- Where
- 2 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Limoges
Obstructive Sleep Apnea, Down Syndrome
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep…
- Trial name
- TOPS-DS (NCT05508971)
- Testing
- DISE-Directed Surgery, Adenotonsillectomy
- Where
- 7 sites in United States
- Volunteers
- 304 people
- Sponsor
- Oregon Health and Science University
Apnea Neonatal, Apnea of Prematurity
The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants
The aim of this observational study is to investigate whether functional maturation assessment by electroencephalography in preterm infants can provide reliable data for the safe discontinuation of caffeine therapy without…
- Trial name
- NCT07324941
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Uludag University
Hereditary Hemorrhagic Telangiectasia (HHT), Obstructive Sleep Apnea (OSA)
Prevalence of Obstructive Sleep Apnea in HHT and HHT-specific Challenges in OSA-therapy - a Retrospective Cohort Study
Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant vascular disorder (prevalence approx. 1:5,000-1:8,000) characterized by recurrent epistaxis, mucocutaneous telangiectasias and visceral vascular malformations.
- Trial name
- NCT07886632
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Essen
Preterm Neonates, Apnea of Prematurity
The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates at Assiut University Children Hospital NICU
Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.
- Trial name
- NCT07274969
- Volunteers
- 40 people
- Sponsor
- Assiut University
Obstructive Sleep Apnea, Down Syndrome
Validation of Sleep Questionnaires in the Down Syndrome Population
This will be a prospective validation study of a sample of consecutive pediatric Down syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's.
- Trial name
- NCT03771469
- Testing
- Sleep study
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Preterm Birth, Apnea of Newborn
The Use of Wireless Sensors in Neonatal Intensive Care
The study will be conducted in a convenience sample of 75 infants admitted to the NICU at the Montreal Children's Hospital, divided into 3 phases: (a) Phase 1a - monitoring for 8h per day for 4 consecutive days, (b) Phase 1b …
- Trial name
- NCT04956354
- Testing
- ANNE™ Monitoring System (2 sensors) - version B, ANNE™ Monitoring System (2 sensors) - version C
- Where
- Canada
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Obstructive Sleep Apnea, Down Syndrome
Clinical Outcomes From Treatment and Evaluation of Obstructive Sleep Apnoea in Children With Down Syndrome
The goal of this observational study is to learn about the use of non-invasive ventilation for treatment of obstructive sleep apnoea syndrome in children with Down Syndrome.
- Conditions
- Obstructive Sleep Apnea, Down Syndrome, Quality of Life, Behavior
- Trial name
- REFRESHED (NCT06030349)
- Testing
- Non-invasive ventilation
- Where
- 6 sites in Ireland, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Children's Health Ireland
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Obstructive, Dentofacial Deformities
- Trial name
- SUNRISE-ORTHO (NCT07910461)
- Testing
- Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Sunrise mandibular jaw movement monitoring, Facial multidetector CT in natural head position
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- CHR Sambre et Meuse Site Meuse
Down Syndrome, Obstructive Sleep Apnea
Down Syndrome Obstructive Sleep Apnea
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe…
- Trial name
- DOSA (NCT06043440)
- Testing
- Oxygen
- Where
- 7 sites in United States
- Volunteers
- 230 people
- Sponsor
- Brigham and Women's Hospital
Apnea of Prematurity, Intermittent Hypoxemia
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
The goal of this clinical trial is to learn if a chin strap helps reduce low oxygen episodes in premature babies receiving CPAP or NIPPV (breathing support through the nose).
- Conditions
- Apnea of Prematurity, Intermittent Hypoxemia, Bronchopulmonary Dysplasia of Newborn
- Trial name
- STRAP (NCT07895654)
- Testing
- Chinstrap
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Preterm Labor With Preterm Delivery, Premature Birth
Pharmacokinetics and Placental Transfer of Caffeine
The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery.
- Conditions
- Preterm Labor With Preterm Delivery, Premature Birth, Apnea of Prematurity, Respiratory Distress Syndrome
- Trial name
- AnteCaff (NCT07570121)
- Testing
- Caffeine citrate
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Indiana University
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
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
Hypotonia, Muscle, Obstructive Sleep Apnea
Long-term Evaluation of Nasopharyngeal Airway in Hypotonia
This research is studying the long term use of a nasal airway device (self-supporting nasopharyngeal airway; "ssNPA") in children with hypotonic upper airway obstruction to learn about its effectiveness and tolerability as a…
- Conditions
- Hypotonia, Muscle, Obstructive Sleep Apnea, Nasal Airway Obstruction
- Trial name
- NCT06614582
- Testing
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
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
Apnea of Prematurity
Detection of CardioRespiratory Events Using Acoustic Monitoring in Preterm Infants on CPAP
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.
- Trial name
- DREAM (NCT05196646)
- Testing
- Respiratory Acoustic Sensors, Nasal thermistor, Respiratory Inductive Plethysmography
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Apnea of Prematurity
Caffeine Citrate to Improve Neonatal Outcomes.
The goal of this clinical trial to learn what dose/s of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing.
- Trial name
- BabyCCINO (NCT06972849)
- Testing
- Caffeine citrate
- Volunteers
- 3,900 people
- Sponsor
- University of Melbourne