Trial Outcomes & Findings for Influence of IPV on GOR in Infants From 0 to 12 Months. (NCT NCT02124863)

Results Overview

Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Intrapulmonary Percussive Ventilation number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O
Overall Study STARTED	67
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Influence of IPV on GOR in Infants From 0 to 12 Months.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intrapulmonary Percussive Ventilation n=50 Participants number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O
Age, Categorical <=18 years	50 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	25 Participants n=5 Participants
Gender Male	25 Participants n=5 Participants
Region of Enrollment Belgium	50 participants n=5 Participants

PRIMARY outcome

Timeframe: during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.

Population: All patients receiving IPV were their own controls

Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV

Outcome measures

Outcome measures
Measure	Intrapulmonary Percussive Ventilation n=50 Participants number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O	Control n=50 Participants mean number of refluxes during 20 min, 120 min after each meal
Number of Refluxes	0.48 number of refluxes Standard Deviation 0.76	0.97 number of refluxes Standard Deviation 0.95

Adverse Events

Intrapulmonary Percussive Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

filip van ginderdeuren

vrije universiteit brussel

Phone: +3224763916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place