Pre-TermCOSMICNCT06526091
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
An observational study of Pre-Term, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort Read more about this study
- Who is it for?
- Ages 1 minute to 24 hours
- Conditions the study is for
- Pre-Term
- What is being tested?
- Cerebral NIRS monitoring at delivery
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2023to 1 Oct 2024
- 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 1 minute to 24 hours
- All sexes
- Child
Study population: Preterm infants born at less than 34 completed weeks gestational age at Queen Charlotte and Chelsea Hospital (London) undergoing optimum cord management during birth
Who may be able to join
- All babies eligible for optimum cord management born before 34 completed weeks gestational age
- Parental consent
Who cannot join
- Multiple pregnancies
- Infants for whom resuscitation at birth is not appropriate
- Antenatal or immediate postnatal diagnosis of severe congenital anomaly
- Infants with complex congenital cardiac disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Becky Ward, Becky.Ward@imperial.ac.uk
About this study
Official title: Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort
Read the detailed description
Optimal cord management is defined by delaying clamping of the umbilical cord for 1 minute after delivery and is recommend in all neonates, regardless of gestational age. Transfusion of blood from placenta to baby in this minute enables smooth cardiovascular transition and stable cerebral perfusion. Preterm infants are at increased risk of haemodynamic instability and brain injury if the cord is clamped too early. It remains unclear what the optimum time is to clamp the cord in preterm infants, and it is likely different for each baby. Current monitoring of heart rate and peripheral oxygen saturations does not correlate well with oxygen delivery to the brain. Near infrared spectroscopy (NIRS) is a non-invasive method of measuring regional cerebral oxygenation saturations. NIRS may be a helpful monitoring tool to guide optimum timing of cord clamping in preterm infants.
This study aims to assess the feasibility of using the INVOS 5100 NIRS monitor immediately after delivery in preterm infants born before 34 weeks gestational age. The investigators aim to assess if they can generate meaningful data on brain oxygen levels in the first few minutes of life. The secondary objectives are to use this data to describe the changes in heart rate, peripheral oxygen and cerebral oxygen saturations during placental transfusion and cord clamping.
The investigators will use the INVOS device to measure cerebral oxygenation immediately after delivery, during placental transfusion and cord clamping. We will assess the feasibility of the INVOS device for this purpose. We will use the INVOS data and routinely collected data at delivery to evaluate the effect of optimum cord management on cerebral perfusion, heart rate and peripheral oxygen saturations.
- Conditions
- Pre-Term
- Being tested
- Cerebral NIRS monitoring at delivery
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral NIRS monitoring at deliveryOther
Application of cerebral NIRS monitoring immediately after delivery and during optimum cord management
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Preterm infants born at less than 34 completed weeks gestation Receives: Other: Cerebral NIRS monitoring at delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord management in preterm infants
Measured: 2 years
Secondary outcomes (2)
Arterial saturation (SaO2 in %) monitoring
Evaluating the effect of optimum cord management on SaO2
Measured: 2 years
Oxygenation (FiO2 in %) during stabilisation
Evaluating the effect of preterm stabilisation including optimum cord management on FiO2 (%)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start15 Feb 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-TermStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayanta Banerjee, MD (Res), Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526091
- Sponsor's protocol ID
- 22QC7933
- Acronym
- COSMIC
- Status last verified
- Jul 2024
- First submitted
- 26 Aug 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)
- ClinicalTrials.gov ID
- NCT06526091
- Acronym / sponsor ID
- COSMIC / 22QC7933
- Conditions
- Pre-Term
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 29 Jul 2024 (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.
This study will assess the feasibilty measuring cerebral oxygen saturations using a Near Infrared Spectroscopy (NIRS) monitor immediately after delivery of preterm infants. The investigators aim to evaluate the effects of optimum cord management on cerebral oxygenation in this cohort
Detailed description
Optimal cord management is defined by delaying clamping of the umbilical cord for 1 minute after delivery and is recommend in all neonates, regardless of gestational age. Transfusion of blood from placenta to baby in this minute enables smooth cardiovascular transition and stable cerebral perfusion. Preterm infants are at increased risk of haemodynamic instability and brain injury if the cord is clamped too early. It remains unclear what the optimum time is to clamp the cord in preterm infants, and it is likely different for each baby. Current monitoring of heart rate and peripheral oxygen saturations does not correlate well with oxygen delivery to the brain. Near infrared spectroscopy (NIRS) is a non-invasive method of measuring regional cerebral oxygenation saturations. NIRS may be a helpful monitoring tool to guide optimum timing of cord clamping in preterm infants.
This study aims to assess the feasibility of using the INVOS 5100 NIRS monitor immediately after delivery in preterm infants born before 34 weeks gestational age. The investigators aim to assess if they can generate meaningful data on brain oxygen levels in the first few minutes of life. The secondary objectives are to use this data to describe the changes in heart rate, peripheral oxygen and cerebral oxygen saturations during placental transfusion and cord clamping.
The investigators will use the INVOS device to measure cerebral oxygenation immediately after delivery, during placental transfusion and cord clamping. We will assess the feasibility of the INVOS device for this purpose. We will use the INVOS data and routinely collected data at delivery to evaluate the effect of optimum cord management on cerebral perfusion, heart rate and peripheral oxygen saturations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Other: Cerebral NIRS monitoring at deliveryPreterm infants born at less than 34 completed weeks gestation |
Who may qualify
- Ages
- 1 minute to 24 hours
- Sex
- All
- Age groups
- Child
- Study population
- Preterm infants born at less than 34 completed weeks gestational age at Queen Charlotte and Chelsea Hospital (London) undergoing optimum cord management during birth
Key inclusion criteria (2 listed)
- All babies eligible for optimum cord management born before 34 completed weeks gestational age
- Parental consent
Key exclusion criteria (4 listed)
- Multiple pregnancies
- Infants for whom resuscitation at birth is not appropriate
- Antenatal or immediate postnatal diagnosis of severe congenital anomaly
- Infants with complex congenital cardiac disease
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 |
|---|---|---|
| Cerebral NIRS monitoring at deliveryApplication of cerebral NIRS monitoring immediately after delivery and during optimum cord management | Other | Preterm infants |
Primary outcome
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord
Time frame: 2 years
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord management in preterm infants
2 secondary outcomes
Arterial saturation (SaO2 in %) monitoring
Time frame: 2 years
Oxygenation (FiO2 in %) during stabilisation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Jayanta Banerjee, MD (Res) principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term, run by Imperial College Healthcare NHS Trust at 1 site 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 4 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jayanta Banerjee, MD (Res) (07771826045, jayanta.banerjee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of regional cerebral saturation (rSO2 in %) monitoring using NIRS during optimum cord (time frame: 2 years). 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 29 Jul 2024.