Trial Outcomes & Findings for Non-invasive Intervention for Apnea of Prematurity (NCT NCT02641249)

NCT ID: NCT02641249

Last Updated: 2017-05-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 12 hours of intervention/12 hours of no intervention
• Results posted on: 2017-05-09

Participant Flow

Dates of Recruitment: 10/2014-2/2016 Location: Hospital

Participant milestones

Measure	All Subjects 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: 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.
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In one study subject, the study interventions were discontinued due to worsening of clinical status from sepsis; 3 additional subjects were excluded from the final analysis due to data acquisition issues (missing data), leaving a final sample size of 15

Baseline characteristics by cohort

Measure	All Subjects n=19 Participants 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: 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.
Age, Categorical <=18 years	19 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=19 Participants
Age, Continuous	28.9 weeks STANDARD_DEVIATION 2.1 • n=19 Participants
Sex: Female, Male Female	8 Participants n=19 Participants
Sex: Female, Male Male	11 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=19 Participants
Race (NIH/OMB) Asian	1 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	5 Participants n=19 Participants
Race (NIH/OMB) White	13 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants
Region of Enrollment United States	15 participants n=15 Participants • In one study subject, the study interventions were discontinued due to worsening of clinical status from sepsis; 3 additional subjects were excluded from the final analysis due to data acquisition issues (missing data), leaving a final sample size of 15
Birth Weight	1213 grams STANDARD_DEVIATION 510 • n=19 Participants
Oxygen use	15 Participants n=19 Participants
Caffeine use	16 Participants n=19 Participants

PRIMARY outcome

Timeframe: 12 hours of intervention/12 hours of no intervention

Population: Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity

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

Outcome measures

Measure	No Vibration n=15 Participants 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: 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.	Vibration n=15 Participants 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: 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.
Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention	284.13 breathing pauses Standard Error 41.175	174.27 breathing pauses Standard Error 22.985

SECONDARY outcome

Timeframe: 12 hours of intervention/12 hours of no intervention

Population: Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity

The total number of intermittent hypoxic episodes to <90% (pulse oximetry) lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

Outcome measures

Measure	No Vibration n=15 Participants 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: 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.	Vibration n=15 Participants 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: 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.
Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention	151.67 IH events Standard Error 24.286	109.67 IH events Standard Error 22.661

SECONDARY outcome

Timeframe: 12 hours of intervention/12 hours of no intervention

Population: Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity

The total number of bradycardia episodes to <100 bpm lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).

Outcome measures

Measure	No Vibration n=15 Participants 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: 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.	Vibration n=15 Participants 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: 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.
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 bradycardias Standard Error 23.2	14.93 bradycardias Standard Error 5.674

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kalpashri Kesavan

University of California

Phone: 3108256304

Email: KKesavan@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place