Actively Recruiting
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm (COSMIC Pilot Study)
Led by Imperial College Healthcare NHS Trust · Updated on 2024-07-29
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of measuring brain oxygen levels in preterm infants using a Near Infrared Spectroscopy (NIRS) monitor immediately after birth. The study focuses on infants born before 34 weeks of gestation and aims to understand how delaying umbilical cord clamping for one minute affects cerebral oxygenation. This approach is important because preterm infants are at higher risk for brain injury if the cord is clamped too early, and current monitoring methods do not directly measure oxygen delivery to the brain. The study uses the INVOS 5100 NIRS device to monitor cerebral oxygen saturation right after delivery during the period of optimal cord management, defined as clamping the umbilical cord one minute after birth. The research team will observe changes in heart rate, peripheral oxygen saturation, and cerebral oxygen levels during placental blood transfusion and cord clamping. The goal is to assess if meaningful brain oxygenation data can be gathered using this non-invasive monitor. Participants will be monitored immediately after birth with the INVOS device while routine clinical data are also collected. The researchers will evaluate the feasibility of using the NIRS monitor in this setting and analyze the effects of optimal cord management on cerebral perfusion and oxygenation over a two-year period. This observational study involves follow-up assessments related to oxygen saturation and oxygen delivery during stabilization of the infant.
CONDITIONS
Brief Title
Cerebral Oxygen Saturation Monitoring During Optimum Cord Management in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All babies eligible for optimum cord management born before 34 completed weeks gestational age
- Parental consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Immediately after delivery
Participants undergo cerebral NIRS monitoring immediately after delivery during optimum cord management to assess brain oxygen levels.
1 visit (in-person)
Duration - 2 years
Participants are observed over 2 years to assess cerebral oxygen saturation, arterial saturation, and oxygenation during stabilization.
Trial Site Locations
Total: 1 location
1
Imperial College Healthcare NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
J
Jayanta Banerjee, MD (Res)
L
Laura Edgar, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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