Clinical trials: Neonatal Bradycardia
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
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
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.
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
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
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
Apnea, Bradycardia
MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
Establishing breathing after birth is vital for survival and long-term health of premature babies. 10% of all preterm babies fail to breathe after birth and require help with breathing.
- Trial name
- MRSOPA (NCT02375230)
- Testing
- Control group, MR SOPA
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- University of Alberta
Congenital Heart Disease, Bradycardia Sinus
Specialized Pacing for Patients With Congenital Heart Disease
The closed-loop stimulation (CLS) algorithm is a novel sensor-based technology that relies on the change in myocardial systolic impedance for modulation of the heart rate during physical and emotional stress.3 The pacing…
- Trial name
- NCT03361189
- Testing
- Closed loop stimulation, Standard rate response
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, Los Angeles
Hypoxia, in Liveborn Infant, Neonatal Asphyxia
Infant Special Program for In Hospital Resuscitation Education in the Delivery Room
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.
- Conditions
- Hypoxia, in Liveborn Infant, Neonatal Asphyxia, Neonatal Bradycardia
- Trial name
- INSPIRE-D (NCT02347241)
- Testing
- Educational intervention
- Where
- Norway
- Volunteers
- 435 people
- Sponsor
- Oslo University Hospital
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
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
Apnea, Bradycardia
Detection of Neonatal Bradycardia
Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment.
- Trial name
- INTEM (NCT00950287)
- Testing
- No intervention
- Where
- 3 sites in France
- Volunteers
- 54 people
- Sponsor
- Rennes University Hospital
Apnea Prematurity
Nasogastric Versus Orogastric Route of Feeding in Preterm (<32 Weeks) Neonates
Enteral feeding tubes in newborns are used for feeding preterm and low birth weight babies in neonatal intensive care units as they often do not suck effectively owing to lack of coordination between sucking, swallowing and…
- Trial name
- NCT03073993
- Testing
- feeding tube insertion
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Max Super Speciality Hospital
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 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
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
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
Long QT Syndrome, Sinus Bradycardia
A Study to Evaluate Accuracy and Validity of the Chang Gung ECG Abnormality Detection Software
"Chang Gung ECG Abnormality Detection Software" is a is an artificial intelligence medical signal analysis software that detect whether patients have abnormal ECG signals of 14 diseases by static 12-lead ECG.
- Conditions
- Long QT Syndrome, Sinus Bradycardia, Sinus Tachycardia, Premature Atrial Complexes
- Trial name
- NCT05903313
- Testing
- Chang Gung ECG Abnormality Detection Software
- Where
- Taiwan
- Volunteers
- 4,306 people
- Sponsor
- Chang Gung Memorial Hospital
Apnea of Prematurity, Infant, Premature, Diseases
Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants
This study evaluates the effect of non-invasive high frequency oscillations applied via a highflow nasal cannula ('Osciflow') compared to highflow nasal cannula without oscillations (HF) on desaturations and bradycardia in…
- Trial name
- Osciflow (NCT04327466)
- Testing
- Osciflow, Highflow
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University of Zurich
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