Trial Outcomes & Findings for Cohort Isolation and Cross-infection in Bronchiolitis (NCT NCT01441466)

NCT ID: NCT01441466

Last Updated: 2017-02-17

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 48 participants
• Primary outcome timeframe: duration of hospitalisation, an average of 3-4 days
• Results posted on: 2017-02-17

Participant Flow

Of 84 eligible patients, 48 were included in the study

Participant milestones

Measure	Group Without Isolation Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Overall Study STARTED	37	11
Overall Study COMPLETED	37	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cohort Isolation and Cross-infection in Bronchiolitis

Baseline characteristics by cohort

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	11 Participants n=7 Participants	48 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
Age, Continuous	0.4 years STANDARD_DEVIATION 0.4 • n=5 Participants	0.6 years STANDARD_DEVIATION 0.5 • n=7 Participants	0.5 years STANDARD_DEVIATION 0.4 • n=5 Participants
Gender Female	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Gender Male	20 Participants n=5 Participants	6 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Netherlands	37 participants n=5 Participants	11 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: duration of hospitalisation, an average of 3-4 days

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Duration of Hospital Stay	3.9 days Standard Deviation 3.6	2.1 days Standard Deviation 1.2

SECONDARY outcome

Timeframe: duration of hospitalisation, an average of 3-4 days

number of days the patient has been tube fed

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Number of Days With Tube Feeding	2.2 days Standard Deviation 3.5	0.7 days Standard Deviation 1.3

SECONDARY outcome

Timeframe: duration of hospitalisation, an average of 3-4 days

number of days that supplemental oxygen was needed

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Supplemental Oxygen Needed	2.1 days Standard Deviation 2.6	1.1 days Standard Deviation 1.6

SECONDARY outcome

Timeframe: duration of hospitalisation, an average of 3-4 days

highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Highest Dyspnoea Score	3.4 units on a scale (0-10) Standard Deviation 2.1	2.9 units on a scale (0-10) Standard Deviation 1.7

SECONDARY outcome

Timeframe: duration of hospitalisation, an average of 3-4 days

Mechanical ventilation and endotracheal intubation needed

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Mechanical Ventilation	2 participants	1 participants

SECONDARY outcome

Timeframe: measured until 1 week after hospital exit

nosocomially acquired cross-infection

Outcome measures

Measure	Group Without Isolation n=37 Participants Patients in this arm are nursed together (in the same room) independent of viral agent.	Group With Isolation n=11 Participants Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
Cross-infection	0 participants	2 participants

Adverse Events

Group Without Isolation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group With Isolation

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

Jolita Bekhof

Princess Amlia Children's Clinic, Isala

Phone: +31384245050

Email: j.bekhof@isala.nl

Results disclosure agreements

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