Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000992202
Ethics application status
Approved
Date submitted
5/06/2018
Date registered
13/06/2018
Date last updated
24/10/2019
Date data sharing statement initially provided
24/10/2019
Date results provided
24/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Essential Newborn Observations and Signs study: Investigating vital sign ranges in well newborns greater than 34 weeks gestation. A prospective observation study
Scientific title
The Essential Newborn Observations and Signs study: Investigating vital sign ranges in well newborns greater than 34 weeks gestation. A prospective observation study
Secondary ID [1] 295102 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The ENOS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newborn Health 308175 0
Condition category
Condition code
Reproductive Health and Childbirth 307210 307210 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
This study will explore newborn essential observations such heart and breathing rates, blood pressure, temperature and oxygen levels continuously for up to 6 hours per day for the duration of admission. This will be undertaken to determine the ranges and whether there are differences in each gestational age group for each of these essential (vital) signs.
Intervention code [1] 301436 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306157 0
Heart rate and respiratory rate as assessed by Pulse oximetry
Timepoint [1] 306157 0
From 2 hours post birth then at the beginning and end of monitoring session. One monitoring period per participant.
Primary outcome [2] 306201 0
Temperature as assessed by infrared thermometer
Timepoint [2] 306201 0
From 2 hours post birth then at the beginning and end of monitoring session. One monitoring period per participant.
Primary outcome [3] 306202 0
Blood pressure as assessed by automated digital sphygmomanometer
Timepoint [3] 306202 0
From 2 hours post birth then at the beginning and end of monitoring period. One monitoring period per participant.
Secondary outcome [1] 347801 0
Composite secondary outcome: vital signs during times of feeding, sleeping, awake and alert and crying.

Researcher will ask parents how their baby was during the study to provide context to any variation in vital sign ranges. For example, an increased heart rate may be due to the newborn crying.
Timepoint [1] 347801 0
From 2 hours post birth during monitoring session. One monitoring period per participant.

Eligibility
Key inclusion criteria
Inclusion criteria
• Male and Female Newborns born greater than or equal to 34 weeks gestation
• Born via vaginal delivery or caesarean section
• APGAR score greater than or equal to 7
• Well newborn admitted directly to the postnatal ward, or directly to the special care nursery (for routine
observations in accordance with hospital policy that all newborns born less than 35 weeks gestational age or less than 2400g birthweight require initial admission to the special care nursery.
Minimum age
2 Hours
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
• Male and Female newborns born less than 34 weeks gestation
• Emergency delivery in which the newborn required resuscitative measures at delivery such as assisted
ventilation; cardiopulmonary resuscitation; or surfactant administration
• Admitted directly to the Neonatal Intensive Care nursery
• Has a known congenital disorder (e.g. cardiac, pulmonary)
• Has signs of respiratory distress or a previous episode of respiratory distress requiring treatment
• Had two or more BGLs of less than 2.6mmol/L
• Had two or more temperatures of less than 36.5°C
• Phototherapy requiring additional supportive management/treatment in SCN
• Born to a mother with a significant medical condition and/or history of recreational drug use during
pregnancy.
• Retrieved from another healthcare facility
• Discharged from the Royal Brisbane and Women’s Hospital then re-admitted

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
No published studies have continuously monitored biophysical parameters of well newborns over a continuous period of any length of time, which makes calculating a sample size difficult.

To test this hypothesis we are going to conduct an interim analysis of data once 10 newborns per gestational age group have been recruited (30 newborns in total) to inform us of the total sample size required to observe a clinically significant difference between at least one gestational age group.

Parametric and non-parametric will be used to analyse data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2018
Actual
10/10/2018
Date of last participant enrolment
Anticipated
16/12/2018
Actual
10/10/2019
Date of last data collection
Anticipated
21/12/2018
Actual
10/10/2019
Sample size
Target
170
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22881 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 299682 0
Other Collaborative groups
Name [1] 299682 0
The Australian College of Neonatal Nurses
Country [1] 299682 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland,
School of Nursing, Midwifery and Social Work
Level 3, Chamberlain Building, St Lucia, 4072
Queensland
Country
Australia
Secondary sponsor category [1] 299049 0
None
Name [1] 299049 0
Address [1] 299049 0
Country [1] 299049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300584 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 300584 0
Ethics committee country [1] 300584 0
Australia
Date submitted for ethics approval [1] 300584 0
14/05/2018
Approval date [1] 300584 0
31/07/2018
Ethics approval number [1] 300584 0
Ethics committee name [2] 304595 0
Royal Brisbane and Women’s Hospital Research Ethics Committee
Ethics committee address [2] 304595 0
Ethics committee country [2] 304595 0
Australia
Date submitted for ethics approval [2] 304595 0
14/05/2018
Approval date [2] 304595 0
20/06/2018
Ethics approval number [2] 304595 0
HREC/18/QRBW/238
Ethics committee name [3] 304596 0
The University of Queensland Office of Research Ethics
Ethics committee address [3] 304596 0
Ethics committee country [3] 304596 0
Australia
Date submitted for ethics approval [3] 304596 0
01/08/2018
Approval date [3] 304596 0
08/08/2018
Ethics approval number [3] 304596 0
2018001610/HREC/18/QRBW/238

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

Contacts
Principal investigator
Name 84126 0
Mrs Michelle Paliwoda
Address 84126 0
Royal Brisbane and Women’s Hospital
Grantley Stable Neonatal Nursery
Level 5, Ned Hanlon Building,
Herston, Queensland, 4029
Country 84126 0
Australia
Phone 84126 0
+61 7 36468111
Fax 84126 0
Email 84126 0
[email protected]
Contact person for public queries
Name 84127 0
Michelle Paliwoda
Address 84127 0
Royal Brisbane and Women’s Hospital
Grantley Stable Neonatal Nursery
Level 5, Ned Hanlon Building,
Herston, Queensland, 4029
Country 84127 0
Australia
Phone 84127 0
+61 7 36468111
Fax 84127 0
Email 84127 0
[email protected]
Contact person for scientific queries
Name 84128 0
Michelle Paliwoda
Address 84128 0
Royal Brisbane and Women’s Hospital
Grantley Stable Neonatal Nursery
Level 5, Ned Hanlon Building,
Herston, Queensland, 4029
Country 84128 0
Australia
Phone 84128 0
+61 7 36468111
Fax 84128 0
Email 84128 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
Not at this stage


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysiological vital sign reference ranges for well late preterm newborns calculated during a typical 2 h newborn period between 2 h and 7 days of life.2021https://dx.doi.org/10.1088/1361-6579/ac155b
N.B. These documents automatically identified may not have been verified by the study sponsor.