Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000276156
Ethics application status
Approved
Date submitted
16/02/2019
Date registered
25/02/2019
Date last updated
16/09/2022
Date data sharing statement initially provided
25/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Positioning the preterm Infant for Neuroprotection (PIN study)
Scientific title
Optimal head position for the first 72 hours of life: Neuroprotection for the preterm infant? A pilot randomised controlled trial
Secondary ID [1] 297431 0
None
Universal Trial Number (UTN)
U1111-1228-7070
Trial acronym
PIN study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature birth 311603 0
Condition category
Condition code
Neurological 310231 310231 0 0
Other neurological disorders
Reproductive Health and Childbirth 310266 310266 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention studied is optimal head positioning practice for preterm infants in the first 72 hours of life in the Neonatal Intensive Care Unit.

This is a pilot study to determine the feasibility of a randomised controlled trial in terms of whether the recruitment and consenting process is acceptable to parents and practical within fours of delivery which is frequently an emergency situation.

Infants will be nursed on a tilted surface up to 30° (ie. full tilt of Giraffe incubator tray plus positioning pillow determined at nurses discretion) and positioned supine with head in midline for the first 72 hours of life. A freestanding patient positioning mould (Z-Flo™ neonatal positioner) will keep the head in a stable and consistent position including supporting the base of the occiput to prevent forward flexion of the head/neck to reduce likelihood of airway obstruction. The positioner has a low friction/shear surface, maximum contouring ability for moulding to accommodate tubing/wires, and zero memory ensuring it does not move once moulded. The infant will be briefly moved to sidelying position with head in neutral midline, every four hours to check skin integrity.

A laminated chart will be placed on the crib to remind staff of position for each infant.
A checklist will be completed by the nurse at the end of each shift to check head position and probe attached, documentation of any problems encountered and removal of positioner etc. Bedside nurse will report changes in head position for unavoidable medical indications and record duration of changes.

Research nurse will conduct compliance audit prior to the study and compliance during the study.
Intervention code [1] 313683 0
Prevention
Comparator / control treatment
Standard care group.
Currently, there is no standardised head positioning practice of preterm infants in the first 72 hours in the NICU. Many are nursed on tilted surface and/or with head in midline, however this is not consistent. There will be no attempt to standardise the early head positioning practices for the purposes of this study. Data will be collected to describe positioning of the infant during the 72 hours.
Control group
Active

Outcomes
Primary outcome [1] 319115 0
Examine the acceptability of the recruitment and consent to parents-
Measured by number of participants enrolled or not enrolled. Views from parents on the recruitment and consent process will also be gathered by the research nurse using a brief semi-structured interview designed for the study.
Timepoint [1] 319115 0
72 hours of life
Primary outcome [2] 319158 0
To determine the practicality of recruiting participants within 4 hours of life-
Measured by time (hours) to recruit/enroll participant recorded on bedside chart.
Timepoint [2] 319158 0
up to 4 hours
Primary outcome [3] 319159 0
% Compliance with study protocol-
Measured by bedside checklist completed at end of shift with audit at 2 points during 72 hours
Timepoint [3] 319159 0
72 hours of life
Secondary outcome [1] 367010 0
Proportion with intraventricular haemorrhage (any grade) on cranial ultrasound as determined by independent radiologist.
Timepoint [1] 367010 0
72 hours of life
Secondary outcome [2] 367011 0
Median cerebral oxygen saturation (Near Infrared Spectroscopy)
Timepoint [2] 367011 0
Continuous monitoring for first 72 hours of life
Secondary outcome [3] 367142 0
Change in early markers of cerebral palsy using ratings on General movements assessment
Timepoint [3] 367142 0
32 weeks and 36 weeks post conceptual age
3 months corrected age
Secondary outcome [4] 367143 0
Motor ability (ie. total score on Test of Infant Motor Impairment)
Timepoint [4] 367143 0
36 weeks post conceptual age
3 months corrected age
Secondary outcome [5] 367144 0
Cognitive outcome (ie. Cognitive Composite score on the Bayley Scales of Infant Development - 3rd Ed.)
Timepoint [5] 367144 0
2 years corrected age
Secondary outcome [6] 367145 0
Presence of cerebral palsy (Clinical examination by paediatrician)
Timepoint [6] 367145 0
2 years corrected age
Secondary outcome [7] 367195 0
Motor outcome (ie. Motor Composite score on Bayley Scales of Infant Development - 3rd Ed.)
Timepoint [7] 367195 0
2 years corrected age
Secondary outcome [8] 367196 0
change in severity of head turn preference using total score on Head turn Preference Scale
Timepoint [8] 367196 0
36 weeks post conceptual age
Secondary outcome [9] 367242 0
To examine staff satisfaction with the intervention protocol-
Measured by survey developed for the study that rates staff satisfaction with the intervention and includes open-ended questions
Timepoint [9] 367242 0
end of 72 hour intervention period

Eligibility
Key inclusion criteria
1. Gestational age <29 weeks
2. Postnatal age <4 hours
3. Parent consent within 4 hours
Minimum age
0 Hours
Maximum age
4 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Exutero transfer
2. Presence of lethal congenital anomalies
3. Serious congenital cardiac disease
4 Pre-existing intraventricular haemorrhage (determined on baseline cranial ultrasound)
5. Parent not consenting for study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation method, stratified for gestation (23-25+6 or 26-28+6 weeks),
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study is a pilot study and is not powered directly to detect significant change in the primary outcomes of the RCT, however information will be obtained to estimate effect size to be used for power calculation in a planned larger trial.

For the pilot, a sample size of 60 infants (30 in each of the intervention and control groups) will provide interim data to confirm that a planned RCT will be designed with maximal precision.

In relation to analyses, quantitative data will be summarised using descriptive statistics and qualitative data will be examined to identify key issues. This study is not powered for use of inferential statistics.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2019
Date of last participant enrolment
Anticipated
31/05/2020
Actual
29/07/2021
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13165 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 25720 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 301998 0
Charities/Societies/Foundations
Name [1] 301998 0
Research Foundation, Cerebral Palsy Alliance
Country [1] 301998 0
Australia
Primary sponsor type
Hospital
Name
Western Sydney Local Health District
Address
Research Office
Western Sydney Local Health District
Westmead Hospital
Hawkesbury and Darcy Rds.
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 301784 0
None
Name [1] 301784 0
Address [1] 301784 0
Country [1] 301784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302673 0
Western Sydney Local Health District HREC
Ethics committee address [1] 302673 0
Research Office, Level 2, REN Building
Westmead Hospital,
Hawkesbury & Darcy Roads,
Westmead NSW 2145
Ethics committee country [1] 302673 0
Australia
Date submitted for ethics approval [1] 302673 0
30/04/2018
Approval date [1] 302673 0
28/06/2018
Ethics approval number [1] 302673 0
AU RED SSA/18/WMEAD/130

Summary
Brief summary
The purpose of the study is to investigate whether specific positioning of the preterm baby’s head in the first 72 hours of life will reduce brain bleeds and lead to improved developmental outcomes. The first stage is to determine whether this study is acceptable to parents and whether it is possible to recruit preterm babies in the first four hours of life when the delivery is often an emergency situation. We hypothesize that the study will be acceptable to parents and that it will be possible to recruit babies within the four hour time frame.
Babies born less than 29 weeks gestation will receive either usual positioning practice for the first 72 hours or the optimal positioning group. For the usual positioning group, there is currently no standard way to position the preterm baby for the first 72 hours. Babies in the optimal positioning group will be placed on a slightly tilted surface, on their back and with their head in the centre, for 72 hours. The head will be placed on a special pillow designed to mould to the baby’s head and keep the position stable during this time. Brain oxygen levels and presence of brain bleeds will be measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91018 0
Dr Traci-Anne Goyen
Address 91018 0
Neonatal Intensive Care Unit
Level 3
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 91018 0
Australia
Phone 91018 0
+61 02 8890 7469
Fax 91018 0
+61 02 8890 7490
Email 91018 0
[email protected]
Contact person for public queries
Name 91019 0
Pranav Jani
Address 91019 0
Neonatal Intensive Care Unit
Level 3
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 91019 0
Australia
Phone 91019 0
+61 02 8890 7375
Fax 91019 0
+61 02 8890 7490
Email 91019 0
[email protected]
Contact person for scientific queries
Name 91020 0
Traci-Anne Goyen
Address 91020 0
Neonatal Intensive Care Unit
Level 3
Westmead Hospital
Hawkesbury and Darcy Rds
Westmead NSW 2145
Country 91020 0
Australia
Phone 91020 0
+61 02 8890 7469
Fax 91020 0
+61 02 8890 7490
Email 91020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a single centre, pilot trial that does not require data sharing


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
No additional documents have been identified.