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Co2 Monitoring at Preterm Delivery-Observational Study

Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04699708
Acronym
COSTA
Enrollment
150
Registered
2021-01-07
Start date
2021-05-15
Completion date
2022-06-30
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resuscitation

Keywords

Carbon dioxide monitoring, Preterm, Resuscitation

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.

Interventions

DEVICECarbon dioxide monitoring

Blinded recording of CO2 during preterm resuscitation.

Sponsors

South Tees Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Factors influencing carbon dioxide levels during preterm resuscitation1 yearTo 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

MeasureTime frameDescription
Correlation of Co2 with other parameters1 yearCorrelation between oxygen saturation, CO2 and pulse rate.

Countries

United Kingdom

Contacts

Primary ContactPrakash Loganathan, MD
pkannanloganathan@nhs.net+447481492632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026