Co2 Monitoring at Preterm Delivery-Observational Study
COSTA
Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery
1 other identifier
observational
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedStudy Start
First participant enrolled
May 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJune 30, 2021
June 1, 2021
10 months
December 30, 2020
June 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Correlation of Co2 with other parameters
1 year
Study Arms (1)
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.
Interventions
Blinded recording of CO2 during preterm resuscitation.
Eligibility Criteria
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.
You may qualify if:
- All preterm infants ≤ 32 weeks born at the study centres.
- Needing resuscitative measures at the time of birth either in the form of face mask ventilation or intubation.
You may not qualify if:
- Preterm infants below the threshold of viability as determined by the study team.
- Major congenital or chromosomal abnormality (including congenital heart disease, Diaphragmatic hernia, congenital pulmonary airway malformations).
- Severe oligohydramnios (Amniotic fluid index \<5 or deep vertical pool≤2).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
James Cook University Hospital
Middlesbrough, Stockton ON TEES, TS4 3BW, United Kingdom
Imran Ahmed
Sunderland, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2020
First Posted
January 7, 2021
Study Start
May 15, 2021
Primary Completion
March 1, 2022
Study Completion
June 1, 2022
Last Updated
June 30, 2021
Record last verified: 2021-06