Co2 Monitoring at Preterm Delivery-Observational Study

NCT ID: NCT04699708

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-06-30

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.

Conditions

Resuscitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm infants ≤ 32 weeks

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.

Carbon dioxide monitoring

Intervention Type: DEVICE

Blinded recording of CO2 during preterm resuscitation.

Interventions

Carbon dioxide monitoring

Blinded recording of CO2 during preterm resuscitation.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

James Cook University Hospital

Middlesbrough, Stockton ON TEES, United Kingdom

Site Status: RECRUITING

Imran Ahmed

Sunderland, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

United Kingdom

Central Contacts

Prakash Loganathan, MD

Role: CONTACT

pkannanloganathan@nhs.net

+447481492632

Facility Contacts

Joe Millar

Role: primary

joe.millar@nhs.net

01642 854089

Imran Ahmed, MRCPCH

Role: primary

i.ahmed@nhs.net

Other Identifiers

291372

Identifier Type: -

Identifier Source: org_study_id