Co2 Monitoring at Preterm Delivery-Observational Study (COSTA)

Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery

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.

Study Overview

• Status: Recruiting
• Conditions: Resuscitation
• Intervention / Treatment: Device: Carbon dioxide monitoring

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Prakash Loganathan, MD; Phone Number: +447481492632; Email: pkannanloganathan@nhs.net

Study Locations

• United Kingdom
  • Sunderland, United Kingdom
    • Not yet recruiting
    • Imran Ahmed
    • Contact: Imran Ahmed, MRCPCH; Email: i.ahmed@nhs.net
  • Stockton ON TEES
    • Middlesbrough, Stockton ON TEES, United Kingdom, TS4 3BW
      • Recruiting
      • James Cook University Hospital
      • Contact: Joe Millar; Phone Number: 01642 854089; Email: joe.millar@nhs.net
      • Principal Investigator: Prakash Loganathan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Carbon dioxide monitoring; Blinded recording of CO2 during preterm resuscitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Co2 with other parameters	Correlation between oxygen saturation, CO2 and pulse rate.	1 year

Collaborators and Investigators

• Sponsor: South Tees Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Resuscitation; Preterm; Carbon dioxide monitoring
• Other Study ID Numbers: 291372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No