Non-invasive Intervention for Apnea of Prematurity

NCT02641249 | Completed Results

• 1 other identifier: IRB#14-000804
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Apnea of Prematurity; Hypoxia; Bradycardia

Outcome Measures

Primary Outcomes (1)

• Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention

  The total number of apneas/breathing pauses will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

  12 hours of intervention/12 hours of no intervention

Secondary Outcomes (2)

• Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention

  12 hours of intervention/12 hours of no intervention

• Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention

  12 hours of intervention/12 hours of no intervention

Study Arms (2)

No vibration

NO INTERVENTION

In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.

Vibration

EXPERIMENTAL

In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.

Device: Vibration

Interventions

Vibration DEVICE

A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject.

Also known as: (no generic name)

Vibration

Eligibility Criteria

• Age: 1 Week+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age \> 23 weeks, \< 34 weeks
• At least 1 week old at recruitment
• Diagnosis of apnea of prematurity (AOP)

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Ronald Reagan Medical Center - UCLA

Los Angeles, California, 90095, United States

Location

Santa Monica UCLA Mecial Center

Santa Monica, California, 90404, United States

Location

Related Publications (1)

• Kesavan K, Frank P, Cordero DM, Benharash P, Harper RM. Neuromodulation of Limb Proprioceptive Afferents Decreases Apnea of Prematurity and Accompanying Intermittent Hypoxia and Bradycardia. PLoS One. 2016 Jun 15;11(6):e0157349. doi: 10.1371/journal.pone.0157349. eCollection 2016.

  PMID: 27304988 RESULT

MeSH Terms

Conditions

Apnea; Hypoxia; Bradycardia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Results Point of Contact

• Title: Dr. Kalpashri Kesavan
• Organization: University of California

KKesavan@mednet.ucla.edu

3108256304

Study Officials

• Kalpashri Kesavan, MBBS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: In the same subject there were 2 periods: Arm 1. 'No intervention' period (no vibrations) - two 6 hour epochs - total of 12 hours of 'No intervention' Arm 2. Experimental period (with vibrations) - two 6 hour epochs - total of 12 hours of 'vibration intervention' In the same subjects cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the experimental period (vibration) and druing the no intervention period (no vibration).

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: May 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (2)