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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

Treatment: Devices

Intervention code [2]

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]

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]

12 months pre- and post-intervention

Secondary outcome [1]

None

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/01/2011

Date of last participant enrolment

Anticipated

Actual

31/12/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

3000

Accrual to date

Final

2822

Recruitment outside Australia

Country [1]

Myanmar

State/province [1]

Yangon

Country [2]

Myanmar

State/province [2]

Mandalay

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Archdiocese of Trento

Address [1]

C/O Amici della Neonatologia, Trentina
Corso 3 Novembre, 116
38122 TRENTO

Country [1]

Italy

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Amici della Neonatologia, Trentina

Address [2]

Corso 3 Novembre, 116
38122 TRENTO

Country [2]

Italy

Funding source category [3]

Other

Name [3]

Eric Hemel & Barbara Morgen

Address [3]

Private - not for public disclosure

Country [3]

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]

None

Name [1]

Not Applicable

Address [1]

Not Applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Committee on Medical Research Involving Human Subjects, Department of Health, Myanmar

Ethics committee address [1]

4 Zeya Htani Rd
Nay Pyi Taw, Myanmar 
[Postal code N/A]

Ethics committee country [1]

Myanmar

Date submitted for ethics approval [1]

07/11/2014

Approval date [1]

28/01/2015

Ethics approval number [1]

#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

Dr Gaston Arnolda

Address

Adjunct Senior Lecturer,
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041

Country

Australia

Phone

+61405720550

Fax

N/A

gaston.arnolda@gmail.com

Contact person for public queries

Name

Gaston Arnolda

Address

Adjunct Senior Lecturer
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041

Country

Australia

Phone

+61405720550

Fax

N/A

gaston.arnolda@gmail.com

Contact person for scientific queries

Name

Gaston Arnolda

Address

Adjunct Senior Lecturer,
Department of Public Health and Community Medicine,
University of New South Wales
C/o 15 Trouton St
Balmain, NSW, 2041

Country

Australia

Phone

+61405720550

Fax

N/A

gaston.arnolda@gmail.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	Evaluation of a simple intervention to reduce exchange transfusion rates among inborn and outborn neonates in Myanmar, comparing pre- and post-intervention rates	2015	https://doi.org/10.1186/s12887-015-0530-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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