Apnea Clinical Trial
OBJECTIVES: I. Assess and compare the incidence and severity of cardiorespiratory events
documented by home monitoring in infants at increased epidemiological risk for sudden infant
death syndrome (SIDS).
II. Determine the antecedent medical, demographic, physiologic, and behavioral
characteristics that predict the incidence of cardiorespiratory events documented by home
monitoring.
PROTOCOL OUTLINE: This is a multicenter collaborative study. Patients are stratified into 4
groups: healthy term infants, apnea of infancy, subsequent siblings of SIDS victims, and
preterm infants.
The caregivers are trained in the use of home monitor equipment and in the graded response
to monitor alarms (observation, gentle stimulation, more vigorous stimulation, mouth to
mouth breathing, and full cardiopulmonary resuscitation).
Caregivers undergo infant cardiopulmonary resuscitation (CPR) training (not required for
caregivers of healthy term infants).
Demographic information is obtained on each infant. A 30 second recording of each infant's
cry is performed at study entry and at 1 month corrected age, and at the polysomnogram. A
urine sample is collected and frozen.
The CHIME monitor is used during sleep and whenever the infant is not being observed.
An overnight polysomnography is performed within 2 weeks of study entry. At 1, 2.5, 6, and
12 months corrected age, infants participate in a clinical evaluation. Neurodevelopmental
status is assessed at 1, 4, and 12 months corrected age.
;
Primary Purpose: Screening
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02580526 -
Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia
|
N/A | |
| Completed |
NCT02627001 -
Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial
|
Phase 4 | |
| Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
| Completed |
NCT02103777 -
High Versus Low Dose of Caffeine for Apnea of Prematurity
|
Phase 3 | |
| Completed |
NCT00950287 -
Detection of Neonatal Bradycardia
|
N/A | |
| Recruiting |
NCT00382876 -
Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat
|
N/A | |
| Completed |
NCT00369759 -
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
|
N/A | |
| Completed |
NCT04084535 -
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.
|
N/A | |
| Recruiting |
NCT02968797 -
Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
|
||
| Completed |
NCT02554110 -
Peripheral Nerve Stimulation to Reduce Hypoxic Events
|
N/A | |
| Not yet recruiting |
NCT04366414 -
Breathing Protocol in Breath-hold Divers
|
N/A | |
| Completed |
NCT05124093 -
The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea
|
N/A | |
| Recruiting |
NCT01994785 -
Use of Capnography in EGD and Colonoscopy With Moderate Sedation.
|
N/A | |
| Completed |
NCT01435486 -
Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
|
N/A | |
| Completed |
NCT01852929 -
Sleep Apnea and Visual Perceptual Skill Learning
|
N/A | |
| Completed |
NCT00389909 -
Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants
|
Phase 4 | |
| Completed |
NCT00188968 -
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
|
Phase 3 | |
| Not yet recruiting |
NCT05396274 -
High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
|
N/A | |
| Completed |
NCT02800213 -
Ventilation Using a Bag Valve Mask With Supplemental External Handle
|
N/A | |
| Completed |
NCT02375230 -
MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room
|
N/A |