N/A N=19 Randomized Treatment

Non-invasive Intervention for Apnea of Prematurity

Apnea of Prematurity · Hypoxia · Bradycardia

Bottom Line

View on ClinicalTrials.gov: NCT02641249 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention — 284.13; 174.27 breathing pauses

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vibration (Device)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention	284.13; 174.27	—
SECONDARY Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention	151.67; 109.67	—
SECONDARY Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention	50.53; 14.93	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02641249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.