Co2 Monitoring at Preterm Delivery-Observational Study

• Conditions: Resuscitation
• Interventions: Device: Carbon dioxide monitoring

• Registration Number: NCT04699708
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation.

Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This study involves monitoring of CO2 during preterm stabilisation.

Detailed Description

Measurement of exhaled CO2 in the delivery room is feasible, but clinical benefits of during neonatal transition have not been studied. Volume ventilation in the Neonatal unit has been shown to improve outcomes such BPD or death. Despite the proven benefits of volume ventilation in the neonatal unit volume guided resuscitation at birth remains an unproven and under-studied technique.

CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation. Currently there is insufficient data on Co2 levels for preterm babies requiring resuscitation. This data would help in finding out optimal resuscitation strategies (Pressures/volume, frequency of breaths) rather than providing the same for all infants throughout the process of resuscitation and would help us in better interpretation Co2 levels in the future resuscitation.

Investigators aim to study the impact of various clinical (Gestation, Birth weight, need for intubation/bag-mask ventilation) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on CO2 during preterm stabilisation.

Study Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-05-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-30
• Primary Completion: 2022-03
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. All preterm infants ≤ 32 weeks born at the study centres.
2. Needing resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.

Exclusion Criteria

1. Preterm infants below the threshold of viability as determined by the study team.
2. Major congenital or chromosomal abnormality (including congenital heart disease, Diaphragmatic hernia, congenital pulmonary airway malformations).
3. Severe oligohydramnios (Amniotic fluid index <5 or deep vertical pool≤2).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants ≤ 32 weeks	Carbon dioxide monitoring	All preterm infants ≤ 32 weeks born in two study centers receiving resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.

Primary Outcome Measures

Name	Time	Method
Factors influencing carbon dioxide levels during preterm resuscitation	1 year	To study the impact/correlation of various clinical factors (Gestation, Birth weight, need for intubation/bag-mask ventilation, surfactant administration, delayed cord clamping) and resuscitative factors (use of inflation pressures, ventilation pressures, frequency of breaths, face mask ventilation, intubation) on carbon dioxide measurements using MASIMO NOMOLINE capnography during preterm stabilisation.

Secondary Outcome Measures

Name	Time	Method
Correlation of Co2 with other parameters	1 year	Correlation between oxygen saturation, CO2 and pulse rate.

Trial Locations

Locations (2)

James Cook University Hospital; 🇬🇧 Middlesbrough, Stockton ON TEES, United Kingdom

Imran Ahmed; 🇬🇧 Sunderland, United Kingdom