Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Regional Blood Saturation Levels in Gastroschisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533439
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
NHS Lothian

Brief Summary:

Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%. The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo.

Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this does not seem to be the norm, as most cases do well in the silo. Cases of intestinal ischaemia within the silo have been described in patients. Any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome.

Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen saturation using NIRS is already in clinical application in other neonatal and paediatric medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery.

The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients.

The aim of the study will be to:

  1. Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
  2. Identify the clinical progress of patients with gastroschisis in the postnatal period
  3. Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications

Condition or disease Intervention/treatment
Gastroschisis Intestinal Ischemia Diagnostic Test: Near infrared spectroscopy

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regional Haemoglobin Oxygen Saturation in the Splanchnic Circulation in Neonates With Gastroschisis; Quantifying and Qualifying the Role for Routine Monitoring
Actual Study Start Date : October 15, 2013
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Near infrared spectroscopy
    Four channel measurement of regional haemoglobin oxygen saturation (SO2) in the blood of the bowel, kidney and brain of neonates with gastroschisis during reduction within a silo and after surgery will be performed.• Routine surgical procedure will be followed (clinically indicated silo placement and closure as is currently practised). There will be no change in the clinical practice in place during this pilot study. Clinical management will be as already practiced with the supervision of the consultant with clinical responsibility dictating management
    Other Name: in-vivo optical spectroscopy oximeter; INVOS (Somanetics, Troy, Mich).


Primary Outcome Measures :
  1. The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2 [ Time Frame: Through study completion, an average of 6 weeks ]

Secondary Outcome Measures :
  1. Time to full feeds [ Time Frame: Through study completion, an average of 6 weeks ]
  2. Changes in renal oxygenation measured by near infra-red spectroscopy [ Time Frame: Through study completion, an average of 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newborn babies at neonatal unit
Criteria

Inclusion Criteria:

  • Gastroschisis diagnosed antenatally or at birth

Exclusion Criteria:

  • Associated congenital condition affecting respiratory system , cardiovascular system or global development
  • Generalised sepsis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533439


Sponsors and Collaborators
NHS Lothian
Investigators
Layout table for investigator information
Principal Investigator: Merrill McHoney, PhD NHS Lothian
Layout table for additonal information
Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT03533439    
Other Study ID Numbers: 2013/0117
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroschisis
Ischemia
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical