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Trial registered on ANZCTR


Registration number
ACTRN12617000479303
Ethics application status
Approved
Date submitted
19/03/2017
Date registered
3/04/2017
Date last updated
3/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Thresholds for Phototherapy in Newborns <32 weeks gestational age
Scientific title
Does a higher threshold for phototherapy worsen the rate of rise in bilirubin in the first 72 hours of life for neonates <32 weeks gestation age?
Secondary ID [1] 291405 0
Nil known
Universal Trial Number (UTN)
U1111-1194-0636
Trial acronym
TPIN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Jaundice 302422 0
Condition category
Condition code
Reproductive Health and Childbirth 301989 301989 0 0
Complications of newborn
Blood 302092 302092 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational study with historical controls. It will be focusing on neonatal outcomes (e.g. serum bilirubin, duration of phototherapy, etc) after phototherapy has been commenced according to the guidelines introduced.

In the new guideline, phototherapy threshold is as follows: initiated at 60umol/L at 0 hours. Thresholds increases in a straight line until it reaches the value at the 72 hour plateau from the UK NICE guidelines. The new guidelines were introduced as part of standard care delivered at the site. This project is a quality improvement trial.

The prospective group will be observed from 17/03/17 to 17/09/17. The follow-up period for each participant will be until discharge.

As the exposure is the new guidelines that have been established within the NICU, it will be delivered by the NICU staff. The decision to start phototherapy, duration and type is determined, as per standard practice, by the attending physician and their team.
Intervention code [1] 297439 0
Not applicable
Comparator / control treatment
Historical control who were treated with the previous guidelines for phototherapy. The previous guidelines used were the UK NICE Guidelines [URL: https://www.nice.org.uk/guidance/cg98/.../treatment-threshold-graphs-544300525]. UK NICE phototherapy threshold line begins at 40umol/L at 0 hours until reaching plateau at 72 hours. The plateau varies by gestational age.

The data will be collected from Royal Hospital for Women Powerchart and medical record files. This will include all neonates that match the criteria admitted from 01/01/16 to 31/12/16.
Control group
Historical

Outcomes
Primary outcome [1] 301416 0
Serum Bilirubin from electronic medical records
Timepoint [1] 301416 0
From Birth to 7 days post-natal age
Secondary outcome [1] 332562 0
Duration of Phototherapy taken from the medical records.
Timepoint [1] 332562 0
From birth until discharge of neonate
Secondary outcome [2] 332564 0
Plasma Sodium from Electronic Medical Records
Timepoint [2] 332564 0
From birth until 3 days post-natal age
Secondary outcome [3] 332565 0
Weight from medical records
Timepoint [3] 332565 0
From birth until 7 days post-natal age
Secondary outcome [4] 332566 0
Mortality from the medical records
Timepoint [4] 332566 0
From Birth until discharge of neonate
Secondary outcome [5] 332947 0
Significant morbidity from medical records
Timepoint [5] 332947 0
From birth until discharge of neonate

Eligibility
Key inclusion criteria
Babies <72 hrs old who undergo phototherapy
Babies born at <32 weeks gestational age
Minimum age
0 Hours
Maximum age
72 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known congenital anomalies
Known risk factors for hyperbilirubinemia including blood group incompatibility, G6PD deficiency, multiple bruising
Conjugated hyperbilirubinemia

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
This is a time specific quality improvement project done as part of independent learning project and the anticipated number of infants during the 6 months of the study would be approximately 60. The historical controls will be all the patients matching the criteria from 2016.

Statistical analyses will be performed using SPSS (IBM Corp. IBM SPSS Statistics for Windows, version 24.0.0.0. Released 2017. Armonk, NY). Categorical outcome data will be presented as percentages with odds ratio (OR) and 95% confidence interval (CI). Continuous data will be tested for homogeneity of variance using Levene’s test. Non-parametric variables will be compared using either Mann-Whitney U-test.. Parametric variables will be compared using student t test. All p values will be two-sided and the significance level is set at <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/03/2017
Date of last participant enrolment
Anticipated
17/09/2017
Actual
Date of last data collection
Anticipated
17/09/2017
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7647 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 15558 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 295939 0
Self funded/Unfunded
Name [1] 295939 0
Country [1] 295939 0
Primary sponsor type
Individual
Name
Srinivas Bolisetty
Address
Department of Newborn Services, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 294836 0
None
Name [1] 294836 0
Address [1] 294836 0
Country [1] 294836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297157 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297157 0
G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Enter via Edmund Blacket courtyard
Cnr High and Avoca Street Randwick NSW, 2031
Ethics committee country [1] 297157 0
Australia
Date submitted for ethics approval [1] 297157 0
14/02/2017
Approval date [1] 297157 0
13/03/2017
Ethics approval number [1] 297157 0
17/047

Summary
Brief summary
The purpose of the study is to determine whether higher threshold for commencing phototherapy will worsen the rate of rise in bilirubin in the first 72 hours of life in newborns born <32 weeks gestational age.
We hypothesise that the higher threshold for phototherapy will result in similar trends in bilirubin levels, duration of phototherapy and number of infants reaching bilirubin levels <25umol/L below exchange threshold in both groups.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1566 1566 0 0
/AnzctrAttachments/372528-Phototherapy-Trial-protocol-v4-dated-9-March-2017.docx (Protocol)
Attachments [2] 1567 1567 0 0
/AnzctrAttachments/372528-PAG Study Review TPIN Study.docx (Other)

Contacts
Principal investigator
Name 73170 0
Dr Srinivas Bolisetty
Address 73170 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 73170 0
Australia
Phone 73170 0
+61 2 93826190
Fax 73170 0
+61 2 93826191
Email 73170 0
[email protected]
Contact person for public queries
Name 73171 0
Srinivas Bolisetty
Address 73171 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 73171 0
Australia
Phone 73171 0
+61 2 93826190
Fax 73171 0
+61 2 93826191
Email 73171 0
[email protected]
Contact person for scientific queries
Name 73172 0
Srinivas Bolisetty
Address 73172 0
Department of Newborn Care, Royal Hospital for Women, Barker St, Randwick NSW 2031
Country 73172 0
Australia
Phone 73172 0
+61 2 93826190
Fax 73172 0
+61 2 93826191
Email 73172 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
No additional documents have been identified.