COSMIC Pilot Study
Research type
Research Study
Full title
Cerebral Oxygen Saturation Monitoring during Optimum Cord Management in Preterm Infants(COSMIC pilot study)
IRAS ID
316018
Contact name
Jayanta Banerjee
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust/Imperial College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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. We aim to assess if we can generate meaningful data on brain oxygen levels in the first few minutes of life. Our 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.
We 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.
REC name
North of Scotland Research Ethics Committee 2
REC reference
22/NS/0129
Date of REC Opinion
24 Oct 2022
REC opinion
Further Information Favourable Opinion