Clinical trials: Neonatal Bradycardia
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, 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
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, 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
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
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
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
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
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
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
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, 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
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
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 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
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, 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
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
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
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