Measuring the increase in exhaled carbon dioxide in spontaneously breathing infants at birth, the RISE study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000174583
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Prof Peter Davis
• Public title: Measuring the increase in exhaled carbon dioxide in spontaneously breathing infants at birth, the RISE study
• Scientific title: Measurement of exhaled carbon dioxide, tidal volume, heart rate, and saturation of peripheral oxygen in infants born >34 6/7 weeks gestation not expected to require respiratory support at birth
• Date of first enrolment: 08/03/2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000174583.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Convenience sample;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Douglas Blank

• Name: Dr Douglas Blank

Key inclusion & exclusion criteria

Inclusion criteria: All inborn infants, term and preterm born at 35 weeks or later gestational age, who are not expected to require respiratory support at birth, are eligible for this study.
Exclusion criteria: Infants will be excluded from analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or respiratory drive including: infants born to mothers receiving general anesthesia and congenital diaphragmatic hernia. Infants will also be excluded if their parents refuse to give consent to this study. During the study, if there are any signs of respiratory compromise, the study will be abandoned and ventilatory support given according to the Australian Neonatal Resuscitation guidelines.

Age minimum: No limit
Age maximum: Hours
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Complications of newborn

Respiratory - Normal development and function of the respiratory system

Reproductive Health and Childbirth - Childbirth and postnatal care

Neonatal resuscitation;Lung aeration at birth;
Neonatal resuscitation
Lung aeration at birth

Intervention(s)

This is a prospective, observational study of spontaneously breathing term and late preterm infants in the delivery room. The primary outcome will be the measured exhaled carbon dioxide levels in the first ten minutes of life.

A combined neonatal CO2/Flow sensor (Neonatal CO2 Flow Sensor, Phillips Healthcare, Massachusetts, USA) will be attached to a face mask (Laerdal round mask, Laerdal, Stavanger, Norway or Neonatal Resuscitation Masks, Fisher&Paykel, Auckland, New Zealand). Immediately after birth, a face mask will be placed over the mouth and the nose. Infants will breathe through the mask.

The NM3 Respiratory Profile Monitor (Phillips Healthcare, Massachusetts, USA). consists of a combined CO2/Flow sensor which measures exhaled carbon dioxide with an infrared light beam at different wavelengths in order to precisely determine gas concentrations in the expired breaths. In addition, the monitor can record pulse and SpO2 via pulse oximetry, with a 2 second averaging time. The respiratory gas measurements are obtained by continuously measuring the infrared light absorption in gas flow through an adapter in the breathing circuit. Gas flow, tidal volume, respiratory rate and airway pressures are measured with a flow sensor. The dead space of the CO2/Flow neonatal sensor is less than 1 mL according to the manufacturer and unlikely to interfere with breathing.

We plan to obtain the measurements immediately after the baby is delivered and continue whilst the baby is lying on the mother’s chest. The purpose of the study is to measure exhaled carbon dioxide during the transition of a healthy newborn, starting with the baby’s first breath. The natural transition of the healthy newborn includes bonding with the mother after birth. To minimize interference

Primary Outcome(s)

The primary outcome for this study will be measuring the exhaled carbon dioxide levels using the NM3 Respiratory Profile Monitor.[Exhaled carbon dioxide levels will be measured every minute for the first ten minutes of life, than once at 1-2 hours of life and once at 12-72 hours of life. ]

Secondary Outcome(s)

The change in saturation of peripheral oxygenation (SpO2) from birth using the NM3 monitor.[Exhaled carbon dioxide measurements will be made continuously during first minute of life, then for 20 seconds every minute of life from 2-10 minutes, then for 20 seconds at 1-2 hours, and again for 20 seconds at 12-72 hours when babies without respiratory distress would be expected to have completed cardiopulmonary transition. A pulse oximetry sensor will be placed on the baby's right wrist and record continuously from birth to 10 minutes of life, then be removed. The pulse oximetry sensor will be reapplied for 1-2 minutes of continuous monitoring at 1-2 hours of life and at 12-72 hours of life at the same time that exhaled carbon dioxide measurements at being recorded. ]

The change in ECO2 from birth to the change in heart rate (HR) from birth using the NM3 monitor. [Exhaled carbon dioxide measurements will be made continuously during first minute of life, then for 20 seconds every minute of life from 2-10 minutes, then for 20 seconds at 1-2 hours, and again for 20 seconds at 12-72 hours when babies without respiratory distress would be expected to have completed cardiopulmonary transition. A pulse oximetry sensor will be placed on the baby's right wrist and record continuously from birth to 10 minutes of life, then be removed. The pulse oximetry sensor will be reapplied for 1-2 minutes of continuous monitoring at 1-2 hours of life and at 12-72 hours of life at the same time that exhaled carbon dioxide measurements at being recorded.]

The change in exhaled tidal volume (TV) from birth using the NM3 Respiratory Profile Monitor. [Exhaled carbon dioxide measurements will be made continuously during first minute of life, then for 20 seconds every minute of life from 2-10 minutes, then for 20 seconds at 1-2 hours, and again for 20 seconds at 12-72 hours when babies without respiratory distress would be expected to have completed cardiopulmonary transition. A pulse oximetry sensor will be placed on the baby's right wrist and record continuously from birth to 10 minutes of life, then be removed. The pulse oximetry sensor will be reapplied for 1-2 minutes of continuous monitoring at 1-2 hours of life and at 12-72 hours of life at the same time that exhaled carbon dioxide measurements at being recorded. ]

Investigate if the change in ECO2 in the first minutes of life is affected by the timing of the baby’s first cry. The timing of the event will be noted by the investigator dictating the timing of the event using an audio recorder placed in the investigators shirt pocket. [Exhaled carbon dioxide measurements will be made continuously during first minute of life, then for 20 seconds every minute of life from 2-10 minutes, then for 20 seconds at 1-2 hours, and again for 20 seconds at 12-72 hours when babies without respiratory distress would be expected to have completed cardiopulmonary transition. A pulse oximetry sensor will be placed on the baby's right wrist and record continuously from birth to 10 minutes of life, then be removed. The pulse oximetry sensor will be reapplied for 1-2 minutes of continuous monitoring at 1-2 hours of life and at 12-72 hours of life at the same time that exhaled carbon dioxide measurements at being recorded.]

The change in exhaled carbon dioxide in the first minutes of life comparing different timing of umbilical cord clamping. The timing of the umbilical cord clamping will be noted by the investigator dictating the timing of the event using an audio recorder placed in the investigators shirt pocket. [Exhaled carbon dioxide measurements will be made continuously during first minute of life, then for 20 seconds every minute of life from 2-10 minutes, then for 20 seconds at 1-2 hours, and again for 20 seconds at 12-72 hours when babies without respiratory distress would be expected to have completed cardiopulmonary transition. A pulse oximetry sensor will be placed on the baby's right wrist and record continuously from birth to 10 minutes of life, then be removed. The pulse oximetry sensor will be reapplied for 1-2 minutes of continuous monitoring at 1-2 hours of life and at 12-72 hours of life at the same time that exhaled carbon dioxide measurements at being recorded.]

Secondary ID(s)

None

Source(s) of Monetary Support

National Health and Medical Research Council Program Grant

The Royal Women's Hospital

Secondary Sponsor(s)

Dr Omar Kamlin

Ethics review

Status: Approved
Approval date:
Contact:

The Royal Women's Hospital Research and Human Research Ethics Committees