Non-invasive Intervention for Apnea of Prematurity
Completed · Not applicable
Conditions studied: Apnea of Prematurity, Hypoxia, Bradycardia
In brief
Purpose of Study: Apnea 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, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure ventilation, and caffeine therapy, none of which is optimal. The objective is to support breathing in premature infants by using a simple, non-invasive vibratory device placed over limb proprioceptor fibers, an intervention using the principle that limb movements facilitate breathing. Methods Used: Premature infants (23-34 wks GA) with clinical evidence of AOP/IH were enrolled 1 week after birth. Caffeine therapy was not a reason for exclusion. Small vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were continuously collected.
Key facts
- Study ID
- NCT02641249
- Run by
- University of California, Los Angeles
- People needed
- 19
- Starts
- 2014-10-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-05-09
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gestational age > 23 weeks, < 34 weeks
- At least 1 week old at recruitment
- Diagnosis of apnea of prematurity (AOP)
- Caffeine treatment will not be an exclusion
You may not qualify if…
- Infants with major congenital anomalies/malformations which will influence central nervous system and long-term outcomes in these infants, such as cardiac anomalies (except for Patent Ductus Arteriosus or Ventricular Septal Defect) or major neurological malformations, like meningoencephalocele, holoprosencephaly etc.
- Neonates who have apnea from airway issues like laryngomalacia or tracheomalacia
- Neonates with history of hypoxic ischemic encephalopathy or Grade IV intraventricular hemorrhage
Where it is running
- Ronald Reagan Medical Center - UCLA — Los Angeles, California, United States
- Santa Monica UCLA Mecial Center — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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