ANZCTR - Registration

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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]

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

Neonate Physiological Parameters

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Primary outcome [3]

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]

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Nil

Address [1]

Nil

Country [1]

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]

Individual

Name [1]

Nick Santamaria

Address [1]

The University of Melbourne
Alan Gilbert Building
104 Grattan Street
Parkville
3050
VIC

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Laura Bignell

Address [1]

The Royal Women's Hospital
20 Flemington Rd
Parkville
3052
VIC

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital Human Research Ethics Commitee

Ethics committee address [1]

20 Flemington Road
Parkville
3052
VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/06/2015

Approval date [1]

29/06/2015

Ethics approval number [1]

15/12

Summary

Brief summary

Skin-to-skin contact (SSC) between a parent and their baby is a commonly used intervention in Neonatal Intensive Special Care Units (NISC). It can help parents to feel more connected to their baby, and feel attached and bonded, as well as help them to feel like they are interacting with their newborn baby, and helping them to feel a little more like a "normal" parent. It also offers multiple benefits to the baby and is the closest for them to being back inside their mother's stomach, as they were before being born. They can hear their mother's heart beat and know their smell, so it can offer the baby comfort and warmth and feel love from their parent.

Over recent years, there has been an increased focus on the use of family centred-care interventions, such as SSC, being utilised in NISCs. 

However, there is an overall lack of studies conducted in Australia on the effect that the duration of the SSC between a parent and baby in a NISC setting has on physiological benefits to the baby, as well as physiological benefits to the parents (both mothers and fathers). 

The physiological measurements examined in the current study are the baby's heart rate, respiratory rate, temperature and oxygen saturation. The parent's physiological measurements examined in the current study are the parent's heart rate and blood pressure.

For the current study, it is hypothesized that the effects from the SSC for the baby will be increased when they have longer SSC with their parent. For the parents, it is hypothesized that there will be physiological benefits from the SSC with their baby, reflected as lower heart rate and blood pressure, and that these benefits will increase with a longer duration of SSC.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Hannah Jones

Address

The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria

Country

Australia

Phone

+61 3 83452000

Fax

hannah.jones@thewomens.org.au

Contact person for public queries

Name

Hannah Jones

Address

The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria

Country

Australia

Phone

+61 3 83452000

Fax

hannah.jones@thewomens.org.au

Contact person for scientific queries

Name

Hannah Jones

Address

The Royal Women's Hospital
20 Flemington Road
Parkville
3052
Victoria

Country

Australia

Phone

+61 3 83452000

Fax

hannah.jones@thewomens.org.au

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

No additional documents have been identified.

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