GastroschisisNCT03533439
Regional Blood Saturation Levels in Gastroschisis
An observational study of Gastroschisis and Intestinal Ischemia, run by NHS Lothian.
Trial 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%. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Gastroschisis, Intestinal Ischemia
- What is being tested?
- Near infrared spectroscopy
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2013to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn babies at neonatal unit
Who may be able to join
- Gastroschisis diagnosed antenatally or at birth
Who cannot join
- Associated congenital condition affecting respiratory system , cardiovascular system or global development
- Generalised sepsis
About this study
Official title: Regional Haemoglobin Oxygen Saturation in the Splanchnic Circulation in Neonates With Gastroschisis; Quantifying and Qualifying the Role for Routine Monitoring
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.
Read more
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:
- Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
- Identify the clinical progress of patients with gastroschisis in the postnatal period
- Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications
- Conditions
- Gastroschisis, Intestinal Ischemia
- Being tested
- Near infrared spectroscopy
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDiagnostic test
Also called in-vivo optical spectroscopy oximeter; INVOS (Somanetics, Troy, Mich).
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
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2
Measured: Through study completion, an average of 6 weeks
Secondary outcomes (2)
Time to full feeds
Measured: Through study completion, an average of 6 weeks
Changes in renal oxygenation measured by near infra-red spectroscopy
Measured: Through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start15 Oct 2013
- Primary completion31 Aug 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Merrill McHoney, PhD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533439
- Sponsor's protocol ID
- 2013/0117
- Status last verified
- Jan 2018
- First submitted
- 23 Apr 2018
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Haemoglobin Oxygen Saturation in the Splanchnic Circulation in Neonates With Gastroschisis; Quantifying and Qualifying the Role for Routine Monitoring
- ClinicalTrials.gov ID
- NCT03533439
- Acronym / sponsor ID
- 2013/0117
- Conditions
- Gastroschisis, Intestinal Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
- Identify the clinical progress of patients with gastroschisis in the postnatal period
- Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn babies at neonatal unit
Key inclusion criteria (1 listed)
- Gastroschisis diagnosed antenatally or at birth
Key exclusion criteria (2 listed)
- Associated congenital condition affecting respiratory system , cardiovascular system or global development
- Generalised sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopyAlso: in-vivo optical spectroscopy oximeter; INVOS (Somanetics, Troy, Mich).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 | Diagnostic test | – |
Primary outcome
The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2
Time frame: Through study completion, an average of 6 weeks
2 secondary outcomes
Time to full feeds
Time frame: Through study completion, an average of 6 weeks
Changes in renal oxygenation measured by near infra-red spectroscopy
Time frame: Through study completion, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroschisis
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Gastroschisis Outcomes of Delivery (GOOD) Study
Gastroschisis
Recruiting
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Gastrointestinal Complication, Intestinal Obstruction
Recruiting
Early Feeds in Gastroschisis
Gastroschisis
RecruitingObservational study
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merrill McHoney, PhD principal investigator
NHS Lothian
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis and Intestinal Ischemia, run by NHS Lothian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of intestinal ischemia requiring intervention and its correlation to measured GSO2 (time frame: Through study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.