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Trial registered on ANZCTR


Registration number
ACTRN12615000823572
Ethics application status
Approved
Date submitted
15/07/2015
Date registered
11/08/2015
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the effect of duration of skin-to-skin contact on the physiological parameters of the neonate and parent in a Neonatal Intensive Special Care Unit.
Scientific title
An observational cohort study examining the effect of duration of skin-to-skin contact on the physiological parameters of the neonate and parent in a Neonatal Intensive Special Care Unit.
Secondary ID [1] 287087 0
Nil
Universal Trial Number (UTN)
U1111-1172-1614
Trial acronym
skin2skin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent Physiological Parameters 295599 0
Neonate Physiological Parameters 295742 0
Condition category
Condition code
Reproductive Health and Childbirth 295877 295877 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For each parent-neonate pair involved in the study, one skin-to-skin contact (SSC) between parent and neonate is being observed.
This SSC can take place at any time during the neonate's admission to the NISC, whilst the neonate is aged between 28 weeks gestation to 34 weeks and 6 days gestation and is on oxygen support.
For the purpose of the study, the length of the SSC between parent and neonate is for the time the parent wishes and the neonate is stable for. The SSC will be observed by the Researchers just once for the purpose of the study.
Intervention code [1] 292330 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295558 0
The percentage of time the neonate's oxygen saturation remain within the target range set by the Researchers during the skin-to-skin contact they undertake with their parent.
Timepoint [1] 295558 0
This will be measured and recorded for the neonate during one skin-to-skin contact they undertake with their parent during their admission to the Neonatal Intensive and Special Care Unit. It will be measured using the MasimoSET LNOP Neo-LSPO2 Pulse Oximeter.
Primary outcome [2] 295689 0
The percentage of time the neonate's heart rate and respiratory rate remains within the target range set by the Researchers during the skin-to-skin contact they undertake with their parent.
Timepoint [2] 295689 0
This will be measured and recorded for the neonate during one skin-to-skin contact they undertake with their parent during their admission to the Neonatal Intensive and Special Care Unit. It will be measured using either the Coviden Kendall 1042 PTS Neonatal Electrodes or the Neolead Catalog N306 Electrodes.
Primary outcome [3] 295690 0
The percentage of time the neonate's temperature remains within the target range set by the Researchers during the skin-to-skin contact they undertake with their parent.
Timepoint [3] 295690 0
This will be measured and recorded for the neonate during one skin-to-skin contact they undertake with their parent during their admission to the Neonatal Intensive and Special Care Unit. It will be measured using the Livingstone Fast-Read Thermometer and by holding the thermometer under the neonate’s axilla for two minutes.
Secondary outcome [1] 315848 0
The physiological effect that having skin-to-skin contact with their neonate has on a parent in a Neonatal Intensive Special Care Unit. This will be measured by observing the parent's blood pressure and heart rate.
Timepoint [1] 315848 0
This will be measured and recorded for the parent during one skin-to-skin contact they undertake with their neonate during the neonate's admission to the Neonatal Intensive and Special Care Unit. It will be measured using a Criticare VitalCare 506N3-DN3 machine,

Eligibility
Key inclusion criteria
Neonates who are admitted to The Royal Women's Hospital Neonatal Intensive and Special Care Unit, and their parents, are eligible to participate if they:
1) Are 28 weeks gestation to 34 weeks and 6 days gestation upon admission to the NISC
2) Are currently receiving oxygen therapy
3) The parents are wanting to provide skin-to-skin contact to their neonate
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates who are admitted to The Royal Women's Hospital Neonatal Intensive and Special Care Unit are excluded if they:
1) Are deemed not to be medically stable to have skin-to-skin contact during the conduction of the research study
2) If their parents do not speak English as a first language
3) Have any of the following requirements or conditions:
*Are receiving high frequency ventilation, sensormedics or nitric oxide
*Have experienced a deterioration within the last 24 hours, as defined by the clinical team
*Are requiring multiple phototherapy lights
*Are suffering from alcohol and drug withdrawal

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Information on the parent’s gender and age and the neonate’s gender, gestational age, birth weight and respiratory support will be presented descriptively. If continuous demographic data are normally distributed, they will be presented as the mean and standard deviation. If the continuous demographic data are non-normally distributed, they will be presented as the median and interquartile range.

The association between the duration of skin-to-skin contact (SSC) and the study outcomes (for parents this is their HR and BP and for the neonate this is the percentage of the SSC that their HR, RR, oxygen saturation and temperature remain with the target range) will be explored using regression analyses. To obtain a trend of the data, a line graph will be used showing the mean of each measurement at each time point.

The number of participants needed to achieve study objectives was determined to be 26. This was calculated by determining to find a correlation coefficient as high as 0.5 between the percentage of time the neonate is in the target range for their oxygen saturation and the duration of SSC, with an 80% power.

Thus, we will have a target of recruiting 35 parent-neonate pairs, acknowledging that due to the setting and nature of the study, low participant retention rates are likely. The study is taking place in a tertiary level NISC, and therefore neonates may be transferred to lower level NISCs when they are deemed to require less intensive care, resulting in a withdrawal rate of participants due to this transfer.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
3/08/2015
Date of last participant enrolment
Anticipated
16/10/2015
Actual
20/01/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4051 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 9980 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 291650 0
Self funded/Unfunded
Name [1] 291650 0
Nil
Country [1] 291650 0
Primary sponsor type
Individual
Name
Hannah Jones
Address
The Royal Women's Hospital
20 Flemington Rd
Parkville
3052
VIC
Country
Australia
Secondary sponsor category [1] 290319 0
Individual
Name [1] 290319 0
Nick Santamaria
Address [1] 290319 0
The University of Melbourne
Alan Gilbert Building
104 Grattan Street
Parkville
3050
VIC
Country [1] 290319 0
Australia
Other collaborator category [1] 278528 0
Individual
Name [1] 278528 0
Laura Bignell
Address [1] 278528 0
The Royal Women's Hospital
20 Flemington Rd
Parkville
3052
VIC
Country [1] 278528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293177 0
The Royal Women's Hospital Human Research Ethics Commitee
Ethics committee address [1] 293177 0
Ethics committee country [1] 293177 0
Australia
Date submitted for ethics approval [1] 293177 0
02/06/2015
Approval date [1] 293177 0
29/06/2015
Ethics approval number [1] 293177 0
15/12

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

Contacts
Principal investigator
Name 58782 0
Miss Hannah Jones
Address 58782 0
The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria
Country 58782 0
Australia
Phone 58782 0
+61 3 83452000
Fax 58782 0
Email 58782 0
[email protected]
Contact person for public queries
Name 58783 0
Hannah Jones
Address 58783 0
The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria
Country 58783 0
Australia
Phone 58783 0
+61 3 83452000
Fax 58783 0
Email 58783 0
[email protected]
Contact person for scientific queries
Name 58784 0
Hannah Jones
Address 58784 0
The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria
Country 58784 0
Australia
Phone 58784 0
+61 3 83452000
Fax 58784 0
Email 58784 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
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Documents added automatically
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