Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526091
Status:
RECRUITING
Last Update Posted:
None
First Post:
2022-08-26
Brief Title:
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm COSMIC Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSMIC
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None