ResuscitationCOSTANCT04699708
Co2 Monitoring at Preterm Delivery-Observational Study
An observational study of Resuscitation, run by South Tees Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Resuscitation
- What is being tested?
- Carbon dioxide monitoring
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 May 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
James Cook University Hospital
Middlesbrough, Stockton ON TEES, TS4 3BW
Joe Millar, 01642 854089, joe.millar@nhs.net
Prakash Loganathan, MD
- Not yet recruiting
Imran Ahmed
Sunderland
Imran Ahmed, MRCPCH, i.ahmed@nhs.net
About this study
Official title: 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.
Read the 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
- Being tested
- Carbon dioxide monitoring
- Keywords
- Carbon dioxide monitoring, Preterm, Resuscitation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide monitoringDevice
Blinded recording of CO2 during preterm resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Carbon dioxide monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Correlation of Co2 with other parameters
Correlation between oxygen saturation, CO2 and pulse rate.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 May 2021
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tees Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699708
- Sponsor's protocol ID
- 291372
- Acronym
- COSTA
- Status last verified
- Jun 2021
- First submitted
- 30 Dec 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon -Di-Oxide Monitoring During Neonatal STAbilization at Delivery
- ClinicalTrials.gov ID
- NCT04699708
- Acronym / sponsor ID
- COSTA / 291372
- Conditions
- Resuscitation
- Keywords
- Carbon dioxide monitoring, Preterm, Resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- South Tees Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants ≤ 32 weeks | – | Device: Carbon dioxide monitoringAll 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. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon dioxide monitoringBlinded recording of CO2 during preterm resuscitation. | Device | Preterm infants ≤ 32 weeks |
Primary outcome
Factors influencing carbon dioxide levels during preterm resuscitation
Time frame: 1 year
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 secondary outcome
Correlation of Co2 with other parameters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation, run by South Tees Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prakash Loganathan, MD (+447481492632, pkannanloganathan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors influencing carbon dioxide levels during preterm resuscitation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.