Clinical trials: Bradycardia Neonatal
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
Numerical Rating Pain Score, the Total Doses of Pethidine Needed Through-out Delivery Will be Measured
Thoracic Erector Spinae Plane Block for Painless 1st Stage Normal Vaginal Delivery: Randomized Controlled Study
this study will test a novel indication for bilateral erector spinae plane block (painless 1st stage normal vaginal delivery) it depends on the hypnosis that the erector spinae plane block blocks the visceral pain also by…
- Conditions
- Numerical Rating Pain Score, the Total Doses of Pethidine Needed Through-out Delivery Will be Measured, the Incidence of Failed Delivery and Need of Cesarean Section Will be Assessed, the Incidence of Transient Fetal Bradycardia or Deceleration After the Administration of the Block Will be Recorded
- Trial name
- NCT04981353
- Testing
- bilateral erector spinae plane block at T11
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Neonatal Bradycardia, Hypoxemia of Newborn
Bradycardia Recognition and Detection in Young Infants Part-I
This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.
- Trial name
- BRADY-I (NCT05774470)
- Testing
- Owlet OSS 3.0
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Alabama at Birmingham
Myotonic Dystrophy, Sudden Cardiac Death
RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy
This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.
- Trial name
- NCT00127582
- Testing
- Electrophysiological study, pacemaker , implantable cardiac defibrillator or loop-recorder implant
- Where
- Italy
- Volunteers
- 537 people
- Sponsor
- Catholic University of the Sacred Heart
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
Apnea of Prematurity, Preterm Birth
Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible…
- Conditions
- Apnea of Prematurity, Preterm Birth, Patent Ductus Arteriosus, Hypoxia, Brain
- Trial name
- NCT04184245
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Apnea Neonatal, Bradycardia Neonatal
Application to Predict Neonatal Apnea With Bradycardia
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
- Trial name
- APNeA (NCT06852053)
- Testing
- Closed-loop Vibro-Tactile Stimulator, Control
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
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
Heart Arrest, Birth Asphyxia
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by…
- Conditions
- Heart Arrest, Birth Asphyxia, Bradycardia
- Trial name
- SURV1VE (NCT02858583)
- Testing
- CC+SI, 3:1 C:V
- Where
- 4 sites in Austria, Canada
- Volunteers
- 27 people
- Sponsor
- University of Alberta
Congenital Disorder
Pacemaker Therapy in Adults With Congenital Heart Defects
Review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications
- Trial name
- NCT00303511
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Emory University
Newborn Infants Having Asystole or Bradycardia at Birth
Chest Compression and Sustained Inflation
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns.
- Trial name
- NCT02083705
- Testing
- CC+SI, 3:1 CPR
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- University of Alberta
Down Syndrome, Bradycardia
Down Syndrome Autonomic Nervous System Induction Bradycardia
Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients.
- Trial name
- DANSIB (NCT05120531)
- Testing
- Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Infant, Premature, Diseases, Premature Birth of Newborn
Elevated Midline Positioning During Diaper Change in Preterm Infants
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants.
- Conditions
- Infant, Premature, Diseases, Premature Birth of Newborn, Pain
- Trial name
- NCT07865897
- Testing
- 30-Degree Elevated Midline Positioning, Standard Lateral Position Diaper Change
- Volunteers
- 80 people
- Sponsor
- Akdeniz University
Heart; Arrest, Newborn, Birth Asphyxia
Does Higher (100% Oxygen) Versus Lower (21% Oxygen) During CC+SI During CPR of Asphyxiated Newborns Improve Time to ROSC
When newborn babies are born without a heartbeat the clinical team has to provide breathing and chest compressions (what is call cardiopulmonary resuscitation) to the newborn baby.
- Conditions
- Heart; Arrest, Newborn, Birth Asphyxia, Bradycardia Neonatal
- Trial name
- SURV1VE-O2 (NCT03902652)
- Testing
- Intervention (21% oxygen during CC+SI), Intervention (100% oxygen during CC+SI)
- Where
- Canada
- Sponsor
- University of Alberta
Bradycardia, Hypoxemia
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.
- Trial name
- NCT01595399
- Testing
- atropine
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- University of Manitoba
Premature Birth, Fragility
Wireless MicroPremVitals Button Sensor in the NICU
A wireless and miniaturized vital sign (ECG, SpO2, Skin Temperature) sensor system, MicroPremVitals Button Sensors was developed by the Dr.
- Conditions
- Premature Birth, Fragility, Apnea of Prematurity, Bradycardia Neonatal
- Trial name
- NCT07732257
- Testing
- Wireless MicroPremVitals Button Sensor System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Stillbirth, Neonatal Respiratory Depression
Newborn Heart Rate as a Catalyst for Improved Survival
Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat and are live born.
- Conditions
- Stillbirth, Neonatal Respiratory Depression, Neonatal Bradycardia, Neonatal Resuscitation
- Trial name
- NCT03799861
- Testing
- Epoch 2: HBB with NeoBeat, Epoch 3: HR-guided HBB
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 24,034 people, healthy volunteers welcome
- Sponsor
- American Academy of Pediatrics
Apnea of Prematurity, Apneic Spells of Newborn Nos
Cardio-respiratory Events in Preterm Infants During Transition
Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants.
- Conditions
- Apnea of Prematurity, Apneic Spells of Newborn Nos, Patent Ductus Arteriosus, Premature Birth
- Trial name
- NCT04123691
- Testing
- pulse oximetry monitoring
- Where
- Italy
- Volunteers
- 32 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Adenovirus, Anesthesia
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved.
- Conditions
- Adenovirus, Anesthesia, Anxiety, Anxiolysis
- Trial name
- PTN_POPS (NCT01431326)
- Testing
- The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 3,520 people
- Sponsor
- Daniel Benjamin
Apnea of Newborn, Hypoxia Neonatal
A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability
Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies…
- Conditions
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- Trial name
- WAVE (NCT04528030)
- Testing
- WAVE device
- Volunteers
- 17 people
- Sponsor
- Inspiration Healthcare