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Trial registered on ANZCTR


Registration number
ACTRN12615001171505
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
2/11/2015
Date last updated
26/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a simple intervention to reduce exchange transfusion rates among inborn and outborn neonates with jaundice in Myanmar, comparing pre- and post-intervention rates
Scientific title
Evaluation of a simple phototherapy-related intervention to reduce exchange transfusion rates, comparing pre- and post-intervention rates in two hospitals treating inborn neonates with jaundice and two hospitals treating outborn neonates with jaundice
Secondary ID [1] 287699 0
None
Universal Trial Number (UTN)
U1111-1175-4663
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exchange transfusion for neonatal jaundice 296533 0
Condition category
Condition code
Reproductive Health and Childbirth 296797 296797 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Provision of high intensity phototherapy and a photo radiometer;
2) Promulgation of standard guidelines for phototherapy and exchange transfusion, as used by the lead Myanmar hospital responsible for neonatal care policy. American Academy of Pediatrics 2004 guidelines for infants born at 35 weeks gestation and above specify Total Serum Bilirubin thresholds for commencement of intensive (>=30 W/cm2 per nm at 430-490 nm) and standard (<30 W/cm2 per nm at 430-490 nm) phototherapy and Exchange transfusion, by infant age in hours and risk factors (including gestational age-group). The UK National Institute of Clinical Excellence 2010 guidelines (used for infants born <35 weeks gestation by the Myanmar lead hospital for neonatal care) provide thresholds for phototherapy and Exchange Transfusion by gestational week at birth, and age in hours. Hospitals were given coloured graphs reproduced from the American Academy of Pediatrics guideline to affix to nursery walls, and MS Excel spreadsheets containing the NICE thresholds. Adherence to the guidelines was not externally monitored during the intervention period.
3) Half day training in use of the equipment and guidelines by an Italian Neonatologist. Training was provided in two cities, Yangon and Mandalay, on separate dates, each catering to key staff from two hospitals; 19 staff attended at one location and 21 at the other. Training was by lecture format, with discussion of the guidelines and exercises to demonstrate use of the guidelines, followed by hands-on practice in use of the equipment.
Intervention code [1] 293092 0
Treatment: Devices
Intervention code [2] 293117 0
Treatment: Other
Comparator / control treatment
The pre-intervention period within each hospital was defined as 1 January to 31 December 2011. Routine care during this period include treatment with existing fluorescent phototherapy machines, none of which provided intensive phototherapy as defined in the American Academy of Pediatrics 2004 guidelines. In this period, each of the four hospitals had its own guideline for commencement and cessation of phototherapy, and for provision of exchange transfusion.
Control group
Historical

Outcomes
Primary outcome [1] 296397 0
Exchange transfusion rate, calculated as a proportion of infants admitted for treatment of jaundice, assessed using data recorded in the exchange transfusion registers and neonatal care unit admission registers, respectively.
Timepoint [1] 296397 0
12 months pre- and post-intervention
Secondary outcome [1] 318338 0
None
Timepoint [1] 318338 0
None

Eligibility
Key inclusion criteria
All infants admitted to the neonatal care unit for treatment of neonatal jaundice, in four Myanmar hospitals, two exclusively treating inborn neonates and two exclusively treating outborn neonates
Minimum age
0 Days
Maximum age
28 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable. Before-after study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Before-After study
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Relative Risk Ratio After vs Before, separately for each hospital, aggregated by the Mantel-Haenszel method separately for the two inborn and outborn strata in the absence of marked heterogeneity. The sample size was pragmatically determined as the number of admissions for jaundice and the number of exchange transfusions performed in a 12 month periods pre- and post-intervention. Historical data indicated that the number of exchange transfusions was likely to be sufficient to detect a halving of the exchange transfusion rate in each of the four hospitals with alpha of 0.05 (two-sided) and at least 80% power, assuming no change in number of admissions for jaundice. Results of this order were considered feasible, as clinicians were performing exchange transfusion due to lack of effective phototherapy to reduces bilirubin levels.. If results were homogenous, within the inborn and outborn strata, aggregation by Mantel-Haenszel methods would increase the power, allowing detection of a smaller reduction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7258 0
Myanmar
State/province [1] 7258 0
Yangon
Country [2] 7259 0
Myanmar
State/province [2] 7259 0
Mandalay

Funding & Sponsors
Funding source category [1] 292251 0
Charities/Societies/Foundations
Name [1] 292251 0
Archdiocese of Trento
Address [1] 292251 0
C/O Amici della Neonatologia, Trentina
Corso 3 Novembre, 116
38122 TRENTO
Country [1] 292251 0
Italy
Funding source category [2] 292252 0
Charities/Societies/Foundations
Name [2] 292252 0
Amici della Neonatologia, Trentina
Address [2] 292252 0
Corso 3 Novembre, 116
38122 TRENTO
Country [2] 292252 0
Italy
Funding source category [3] 292253 0
Other
Name [3] 292253 0
Eric Hemel & Barbara Morgen
Address [3] 292253 0
Private - not for public disclosure
Country [3] 292253 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Thrive Networks
Address
1611 Telegraph Avenue
Suite 1420
Oakland, CA 94612
Country
United States of America
Secondary sponsor category [1] 290928 0
None
Name [1] 290928 0
Not Applicable
Address [1] 290928 0
Not Applicable
Country [1] 290928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293716 0
Ethical Committee on Medical Research Involving Human Subjects, Department of Health, Myanmar
Ethics committee address [1] 293716 0
4 Zeya Htani Rd
Nay Pyi Taw, Myanmar
[Postal code N/A]
Ethics committee country [1] 293716 0
Myanmar
Date submitted for ethics approval [1] 293716 0
07/11/2014
Approval date [1] 293716 0
28/01/2015
Ethics approval number [1] 293716 0
#14/2014

Summary
Brief summary
In Myanmar, approximately half of all neonatal hospital admissions are for hyperbilirubinaemia, and tertiary facilities report high rates of Exchange Transfusion (ET). The aim of this study was to evaluate the effectiveness of the pilot program in reducing ET, separately for inborn and outborn neonates.

The study was conducted in the Neonatal Care Units of four national tertiary hospitals: two exclusively treating inborn neonates, and two solely for outborn neonates. Prior to intervention, no high intensity phototherapy was available in these units. Intervention in late November 2011 comprised, for each hospital, provision of two high intensity LED phototherapy machines, a photo radiometer, and training of personnel. Hospital-specific data were assessed as Relative Risks comparing ET rates pre- and post-intervention, and individual hospital results were pooled when appropriate.
Trial website
None
Trial related presentations / publications
Arnolda G, Thein AA, Trevisanuto D, Aung N, Nwe HM, Thin AA, Aye NSS, Defechereux T, Kumara D, Moccia L: Evaluation of a simple intervention to reduce exchange transfusion rates among inborn and outborn neonates in Myanmar, comparing pre- and post-intervention rates. BMC Pediatrics 2015, 15(1):1-10.
Public notes
Ethical approval was sought and received retrospectively. The intervention was funded by charitable donations on the understanding that the intervention would be promptly implemented.. It was agreed with the Ministry of Health, at the outset, that routinely collected summary data would be used to evaluate the effectiveness of the intervention, and to inform and guide future interventions in Myanmar. The relevant ethics committee meets annually: it was no not considered justified to delay implementation while seeking ethical approval for routine implementation of a proven healthcare intervention (intensive phototherapy); thus it was decided to seek retrospective ethical clearance.

Contacts
Principal investigator
Name 61078 0
Dr Gaston Arnolda
Address 61078 0
Adjunct Senior Lecturer,
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041
Country 61078 0
Australia
Phone 61078 0
+61405720550
Fax 61078 0
N/A
Email 61078 0
gaston.arnolda@gmail.com
Contact person for public queries
Name 61079 0
Dr Gaston Arnolda
Address 61079 0
Adjunct Senior Lecturer
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041
Country 61079 0
Australia
Phone 61079 0
+61405720550
Fax 61079 0
N/A
Email 61079 0
gaston.arnolda@gmail.com
Contact person for scientific queries
Name 61080 0
Dr Gaston Arnolda
Address 61080 0
Adjunct Senior Lecturer,
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041
Country 61080 0
Australia
Phone 61080 0
+61405720550
Fax 61080 0
N/A
Email 61080 0
gaston.arnolda@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary