Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000506897
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
10/05/2012
Date last updated
11/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parental presence on bedside clinical rounds (PPBCR) in a neonatal intensive care unit (NICU).
Scientific title
Effect of parental participation on bedside clinical rounds for their child in NICU compared to non-participation on parental satisfaction and level of parental stress.
Secondary ID [1] 280474 0
Nil
Universal Trial Number (UTN)
U1111-1130-6411
Trial acronym
PPBCR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental presence on bedside clinical rounds in NICU 286407 0
Condition category
Condition code
Public Health 286657 286657 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* The intervention involves the participant (parents or guardian) accompany health care professionals on their bedside clinical rounds to their child.

* After obtaining consent, the participant will be randomised to one of two arms:
1. Attending bedside clinical rounds with health care professionals (PPBCR) group or
2. Non-attending bedside clinical rounds with health care professionals (Non-PPCBR) group.

* Parents will rotate between the above two arms but they will have a break (washout period) before changing from one group to the other.

* The duration of time spent in each group and in washout period depends on their infant gestation. If the infant gestation is more than 30 weeks then duration will be 3 days in each group and washout period (that’s total of 9 days in the whole study). If the infant gestation is less than or equal 30 weeks then duration will be 7 days in each group and washout period (that’s total of 21 days in the whole study).

* At conclusion of each arm, the participant will be asked to complete:
1. NICU parental stressor scale and
2. A satisfaction survey about being involved in clinical bedside rounds.
Intervention code [1] 284793 0
Other interventions
Comparator / control treatment
The comparator or control involves the parents not accompanying health care professionals on their bedside clinical rounds to their child.
Control group
Active

Outcomes
Primary outcome [1] 287060 0
At the conclusion of each of the study arms [study (PPCBR)/control (PPCBR)], parents or guardians will be asked to complete satisfaction surveys which include questions pertaining to parent's insights regarding inclusion or exclusion from bedside clinical rounds. The survey includes questions regarding:
1. Knowledge and understanding
2. Communications and collaboration
3. Privacy and confidentiality
4. Parental Stressor Scale for hospitalized infants.
Timepoint [1] 287060 0
The survey should be completed at the conclusion of each study arm:
1. After attending rounds for 3 or 7 days according to infant gestation
2. After being excluded from rounds for 3 or 7 days according to infant gestation.
Secondary outcome [1] 297377 0
Nil
Timepoint [1] 297377 0
Nil

Eligibility
Key inclusion criteria
Parents (mother and/or their partners) or guardians who fulfil the following criteria will be approached for inclusion in the study:

If their infant is anticipated to stay in NICU for minimal of 11 days. This cut-off is taken as the intervention (PPCBR and non-PPCBR) and washout period will take minimum of 3 days each. In addition we allowed first 2 days for not being included in the study as most mothers will be recovering from delivery/Caesarean Section/Anaesthesia …etc).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents (mother and/or their partners) or guardians who fulfil the following criteria will be excluded from the study:

1. If their infant is anticipated to stay in NICU for less than 11 days

2. If their infant is anticipated to be transferred to another NICU or local hospital in less than 11 days after admission.

3. Refused to participate in the study

4. Parents or guardians who do not have good command of English (it is not practical to include an interpreter during the rounds as this might put pressure on interpreter service (eg. to attend rounds at 08:30 daily for 7 days per patient and also it will lead to significant delay in the rounds).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents will be randomised to start with PPCBR or non-PPCBR intervention using computer generated randomisation protocol. This is done by accessing the trial management website (http://www.discoverquick.com/) which was designed by statistician and information technology consultant not involved in the trial. Access to the website require a password and is restricted to the research team. The randomisation protocol (allocation and sequence) is concealed from the research team and parents and is managed by the trial management website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by accessing a randomisation and sequence protocol. This is done by accessing the trial management website (http://www.discoverquick.com/) which was designed by statistician and information technology consultant not involved in the trial. Access to the website require a password and is restricted to the research team. The randomisation protocol (allocation and sequence) is concealed from the research team and parents and is managed by the trial management website.
To ensure that equal number of parents of extremely premature infants are randomised to start with PPCBR and non-PPCBR intervention, we will stratify the randomisation by infant's gestation (gestation less than or equal 30 and more than 30 weeks) using block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285196 0
Hospital
Name [1] 285196 0
Canberra Hospital Private Practice Trust Fund
Country [1] 285196 0
Australia
Primary sponsor type
Individual
Name
A/Prof Abdel-Latif Mohamed
Address
Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive,
Garran, ACT 2605
Country
Australia
Secondary sponsor category [1] 284067 0
None
Name [1] 284067 0
Nil
Address [1] 284067 0
Nil
Country [1] 284067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287199 0
ACT Health Human Research Ethics
Ethics committee address [1] 287199 0
Ethics committee country [1] 287199 0
Australia
Date submitted for ethics approval [1] 287199 0
14/07/2011
Approval date [1] 287199 0
09/12/2011
Ethics approval number [1] 287199 0
ETH.6.11.121

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34135 0
Address 34135 0
Country 34135 0
Phone 34135 0
Fax 34135 0
Email 34135 0
Contact person for public queries
Name 17382 0
Margaret Broom
Address 17382 0
Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive, Garran, ACT 2605
Country 17382 0
Australia
Phone 17382 0
+61 2 6244 3111
Fax 17382 0
+61 2 6244 3112
Email 17382 0
[email protected]
Contact person for scientific queries
Name 8310 0
A/Prof Abdel-Latif Mohamed
Address 8310 0
Department of Neonatology, The Canberra Hospital, Building 11, Level 3, Yamba Drive, Garran ACT 2605
Country 8310 0
Australia
Phone 8310 0
+61 2 6244 4056
Fax 8310 0
+61 2 6244 3112
Email 8310 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseParental presence on neonatal intensive care unit clinical bedside rounds: Randomised trial and focus group discussion.2015https://dx.doi.org/10.1136/archdischild-2014-306724
N.B. These documents automatically identified may not have been verified by the study sponsor.