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Trial Outcomes & Findings for Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis (NCT NCT02094664)

NCT ID: NCT02094664

Last Updated: 2018-01-08

Results Overview

The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

Results posted on

2018-01-08

Participant Flow

Participant milestones

Participant milestones
Measure
Control
Standard dry oxygen therapy
Treatment
Heated and humidified oxygen therapy
Overall Study
STARTED
16
16
Overall Study
COMPLETED
16
16
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=16 Participants
Standard dry oxygen therapy
Treatment
n=16 Participants
Heated and humidified oxygen therapy
Total
n=32 Participants
Total of all reporting groups
Age, Categorical
<=18 years
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
11 Participants
n=7 Participants
20 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · White
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Black
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Hispanic
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity · Other
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of Enrollment
United States
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Mean RDAI
5.38 units on a scale
STANDARD_DEVIATION 3.65 • n=5 Participants
4.44 units on a scale
STANDARD_DEVIATION 2.61 • n=7 Participants
4.90 units on a scale
STANDARD_DEVIATION 3.16 • n=5 Participants
Mean RR
45.44 bpm
STANDARD_DEVIATION 12.74 • n=5 Participants
48.19 bpm
STANDARD_DEVIATION 11.3 • n=7 Participants
46.8 bpm
STANDARD_DEVIATION 11.9 • n=5 Participants
Mean sick days
4.56 days
STANDARD_DEVIATION 1.36 • n=5 Participants
4.25 days
STANDARD_DEVIATION 1.43 • n=7 Participants
4.41 days
STANDARD_DEVIATION 1.39 • n=5 Participants
Respiratory Syncytial Virus (RSV) positive
11 Participants
n=5 Participants
13 Participants
n=7 Participants
24 Participants
n=5 Participants
Family history of asthma
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Smoke exposure at home
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Inhaled albuterol in emergency department
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Systemic steroids in emergency department
5 Participants
n=5 Participants
6 Participants
n=7 Participants
11 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Outcome measures

Outcome measures
Measure
Control
n=16 Participants
Standard dry therapy therapy
Treatment
n=16 Participants
Heated and humidified oxygen therapy
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Hour 1
4.69 units on a scale
Standard Deviation 3.4
2.69 units on a scale
Standard Deviation 3.2
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Hour 4
4.27 units on a scale
Standard Deviation 3.01
3 units on a scale
Standard Deviation 2.63
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Hour 8
4.33 units on a scale
Standard Deviation 3.34
3.44 units on a scale
Standard Deviation 3.2
Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.
Hour 12
3.64 units on a scale
Standard Deviation 2.25
3.2 units on a scale
Standard Deviation 2.37

PRIMARY outcome

Timeframe: Baseline, Hour 1, Hour 4, Hour 8, and Hour 12

Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.

Outcome measures

Outcome measures
Measure
Control
n=16 Participants
Standard dry therapy therapy
Treatment
n=16 Participants
Heated and humidified oxygen therapy
Change in Respiratory Rate (RR) From Baseline
Baseline
45.44 breaths per minute
Standard Deviation 12.74
48.19 breaths per minute
Standard Deviation 11.3
Change in Respiratory Rate (RR) From Baseline
Hour 1
44.81 breaths per minute
Standard Deviation 12.69
45.81 breaths per minute
Standard Deviation 12.16
Change in Respiratory Rate (RR) From Baseline
Hour 4
45.73 breaths per minute
Standard Deviation 14.26
47.25 breaths per minute
Standard Deviation 8.84
Change in Respiratory Rate (RR) From Baseline
Hour 8
43.75 breaths per minute
Standard Deviation 8.06
43.44 breaths per minute
Standard Deviation 8.74
Change in Respiratory Rate (RR) From Baseline
Hour 12
43.36 breaths per minute
Standard Deviation 8.54
44.93 breaths per minute
Standard Deviation 9.92

SECONDARY outcome

Timeframe: Subjects will be followed for the duration of hospital stay until discharge

Length of hospital stay is measured in days and counted from day of admission to day of discharge.

Outcome measures

Outcome measures
Measure
Control
n=16 Participants
Standard dry therapy therapy
Treatment
n=16 Participants
Heated and humidified oxygen therapy
Length of Hospital Stay
4.44 days
Standard Deviation 2.31
4.56 days
Standard Deviation 4.1

SECONDARY outcome

Timeframe: Subjects will be followed for the duration of oxygen requirement until oxygen discontinued

Duration on supplemental O2 was measured in hours.

Outcome measures

Outcome measures
Measure
Control
n=16 Participants
Standard dry therapy therapy
Treatment
n=16 Participants
Heated and humidified oxygen therapy
Duration of O2 Use
60.02 hours
Standard Deviation 48.93
72.11 hours
Standard Deviation 75.38

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment

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. Diana Chen

UCLA Mattel Children's Hospital

Phone: 3108255930

Results disclosure agreements

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