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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001171505
• Date of registration: 02/11/2015
• Prospective Registration: No
• Primary sponsor: Thrive Networks
• 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
• Date of first enrolment: 01/01/2011
• Target sample size: 3000
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001171505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Myanmar

Contacts

• Name: Dr Gaston Arnolda

• Name: Dr Gaston Arnolda

Key inclusion & exclusion criteria

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
Exclusion criteria: None

Age minimum: Days
Age maximum: 28 Days
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Exchange transfusion for neonatal jaundice;
Exchange transfusion for neonatal jaundice

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

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.

Primary Outcome(s)

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.[12 months pre- and post-intervention]

Secondary Outcome(s)

None[None]

Secondary ID(s)

None

Source(s) of Monetary Support

Archdiocese of Trento

Eric Hemel & Barbara Morgen

Amici della Neonatologia, Trentina

Secondary Sponsor(s)

Not Applicable

Ethics review

Status: Approved
Approval date:
Contact:

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