Co2 Monitoring at Preterm Delivery-Observational Study

Resuscitation Clinical Trial

— COSTA  

Official title:

Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699708
• Other study ID #: 291372
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: June 2022

Study information

• Verified date: June 2021
• Source: South Tees Hospitals NHS Foundation Trust
• Contact: Prakash Loganathan, MD
• Phone: +447481492632
• Email: pkannanloganathan[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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).

Related Conditions & MeSH terms

• Resuscitation

Intervention

Device:
• Carbon dioxide monitoring
Blinded recording of CO2 during preterm resuscitation.

Locations

Country	Name	City	State
United Kingdom	James Cook University Hospital	Middlesbrough	Stockton ON TEES
United Kingdom	Imran Ahmed	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
South Tees Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors influencing carbon dioxide levels during preterm resuscitation	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.	1 year
Secondary	Correlation of Co2 with other parameters	Correlation between oxygen saturation, CO2 and pulse rate.	1 year