NeoPerf Study

• Research type

  Research Study

• Full title

  Neonatal perfusion study – A feasibility study examining the use of laser Doppler speckle imaging to assess neonatal perfusion

• IRAS ID

  155945

• Contact name

  Don Sharkey

• Contact email

  don.sharkey@nottingham.ac.uk

• Research summary

  The aim of the study is to:
  -assess whether laser speckle imaging (LSI) can be used to assist the clinician to predict early deterioration in blood flow (either of bowel or during arterial line use) to prevent associated complications (e.g loss of fingers/ intestine) and unnecessary procedures (removal of dead bowel or arterial lines).
  - assess whether LSI can be used to assist surgeons during operations to remove abnormal intestine to safely predict how much bowel to remove and whether the join/stoma has been made in an area of healthy bowel with good blood flow. Overall this may avoid the unnecessary removal of healthy bowel, which can have a major impact on a child’s ability to absorb nutrients in the long term. Also, making the join in a healthy part avoids complications such as leakage and stricture (scarring of the intestine causing blockage).

  A LSI is a device using a low power safe laser to create a colour coded map of blood flow and can calculate the blood flow to a given area. Potentially a surgeon could use it during an operation to assess the blood flow to a given area and assist in their decision making. At present only visual assessment of the intestine is used to assess the health of the bowel.

  Gastroschisis is a condition where the gut develops on the outside of the body, which is sometimes treated by placing it in a plastic covering (silo). This allows slow return back inside the body.

  An arterial line is device placed into an artery to measure blood pressure.

  The study will be conducted at Nottingham University Hospital sites on the NICU and operating theatres over 12 months.

  Neonates eligible for the study are those:
  -undergoing operation for bowel surgery
  - born with gastroschisis +/- managed with a silo
  - requiring placement of an arterial line

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  14/EM/1081

• Date of REC Opinion

  7 Aug 2014

• REC opinion

  Favourable Opinion