In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12608000357358
• Date of registration: 25/07/2008
• Prospective Registration: Yes
• Primary sponsor: Professor Colin J Morley
• Public title: In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?
• Scientific title: In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?
• Date of first enrolment: 11/11/2008
• Target sample size: 70
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12608000357358.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Australia

Contacts

• Name: Dr. Georg Schmoelzer

• Name: Dr. Georg Schmoelzer

Key inclusion & exclusion criteria

Inclusion criteria: Infants born in the Royal Women's Hospital who need positive pressure ventilation for resuscitation in the delivery room
Exclusion criteria: Infants will be excluded from final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: Congenital Diaphragmatic Hernia. Infants will also be excluded if their parents refuse to give consent to this study.

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

Health Condition(s) or Problem(s) studied

Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life?;
Does the use of a respiratory Function Monitor during positive pressure ventilation reduce face mask leak and improve the target tidal volume in the first ten minutes of life?

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

A randomised controlled trial of a Respiratory Function Monitor during positive pressure ventilation during resuscitation of infants. A flowsensor will be placed between the mask and the Neopuff T-piece-device. This flowsensor measures the airflow and calculates the tidal volume. Each infant requiring positive pressure ventilation at birth will be recorded with the flowsensor in place, the duration of this recording will last during the initial stabilisation in the delivery room.
The duration of the trial is 12 months; we anticipate completing recruitment in October 2009.

Primary Outcome(s)

Reduction of Face mask leak during positive pressure ventilation
The leak is calculated in percentage of inspired tidal volume: leak in percentage= [(inspired tidal volume - expired tidal volume)/inspired tidal volume] * 100.
A t-test for statistical analysis will be performed[when ventilation is no longer required]

Secondary Outcome(s)

Rate of intubation in the delivery room.
During stabilisation in the delivery room the rate of intubation in both groups will be measured. A Chi2 for statistical analysis will be performed[during resuscitation in the delivery room]

Changes in heart rate in the first ten minutes of life
A pulse oximeter will be used to record the heart rate during stabilisation. A Chi2 for statistical analysis will be performed[During the first 10 minutes of life]

Changes in oxygen saturation in the first ten minutes of life
A pulse oximeter will be used to record the oxygen saturation during stabilisation. A Chi2 for statistical analysis will be performed.[During the first 10 minutes of life]

Difference in the delivered tidal volumeThe inspired and the expired tidal volume is measured in both groups. A t-test for statistical analysis will be performed[when ventilation is no longer required]

Days of respiratory support
The total days of respiratory (ventilation, CPAP, oxygen) support during hospital stay will be recorded for each individual baby and both groups will be compared, A Chi2 for statistical analysis will be performed[when ventilation is no longer required]

Days of ventilation
The total days of ventilation support during hospital stay will be recorded for each individual baby and both groups will be compared, A Chi2 for statistical analysis will be performed[when ventilation is no longer required.]

Oxygen treatment at 36 weeks gestational age
If a baby still requires oxygen, CPAP of ventilation. A Chi2 for statistical analysis will be performed[at corrected 36 weeks gestational age]

Secondary ID(s)

NIL

Source(s) of Monetary Support

National Health and Medical Research Council Program Grant

Ethics review

Status: Approved
Approval date:
Contact: