Necrotising EnterocolitisNCT03188380
Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
An observational study of Necrotising Enterocolitis, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.
Trial summary
Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Necrotising Enterocolitis
- What is being tested?
- Plain abdominal radiography and Abdominal ultrasound
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: In this single-gate study we plan to include all consecutive preterm infants (born at <32 weeks of gestation) with suspected necrotizing enterocolitis based on the presence of at least three of the above mentioned clinical symptoms 4-7:
Who may be able to join
- Abdominal distension
- Visible bowels loops
- Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of >50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis)
- Temperature instability (defined as ≥ 2 consecutive measurements)
- Frank bloody stools
- Cardiovascular instability (hypotension; defined as MAP < 30mmHg, tachycardia >160/' or bradycardia < 80/')
Show all 15Show fewer
- Recurrent apnea
- Increase of abdominal girth > 2cm (allowing inter-observer variability of 1 cm) within 12 h
- Abdominal wall erythemia
- And/or at least 2 of the below laboratory findings5:
- Thrombocytopenia < 50 x103/uL
- Leukopenia <6 x106/uL
- CRP > 10 mg/L
- PCT > 1 ng/ml
- Coagulopathy
Who cannot join
- • < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound)
- Congenital abnormalities
- No parental consent
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
Joanna Seliga-Siwecka, MD PhD, +48225966155, joanna.seliga@wum.edu.pl
Joanna Seliga-Siwecka
About this study
Official title: The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%.
Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in expediting diagnosis and management of NEC.
Read more
Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks.
Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.
- Conditions
- Necrotising Enterocolitis
- Being tested
- Plain abdominal radiography, Abdominal ultrasound
- Keywords
- nec, abdominal ultrasound, abdominal radiograph, preterm
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain abdominal radiographyDiagnostic test
After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine.
Abdominal ultrasoundDiagnostic test
If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
| Study group | Role | What they receive |
|---|---|---|
| Plain abdominal radiograph (AR) | After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine. Receives: Diagnostic Test: Plain abdominal radiography; Diagnostic Test: Abdominal ultrasound | |
| Abdominal ultrasound (AUS) | If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. Receives: Diagnostic Test: Plain abdominal radiography; Diagnostic Test: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention time
The time required to initiate conservative and/or surgical treatment after diagnosing NEC with AR versus AR and AUS
Measured: until 40 weeks of post-conceptional age
Secondary outcomes (1)
Sensitivity and specificity
Sensitivity and specificity of a diagnostic strategy involving a combination of AR (reference test) followed by AUS (index test) as compared to AR (reference test) in diagnosing NEC.
Measured: until 40 weeks of post-conceptual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotising EnterocolitisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, Ujastek Obstetrics and Gynaecology Hospital, University Children's Hospital of Cracow
- Responsible party
- Principal investigator, Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188380
- Sponsor's protocol ID
- KAROWA USG VERSION 1.0
- Status last verified
- May 2020
- First submitted
- 11 May 2017
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All de-identified data collected during the trial will be available. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
Publications
Seliga-Siwecka J, Rutkowski J, Margas W, Puskarz-Gasowska J, Bokiniec R. Sensitivity and specificity of different imaging modalities in diagnosing necrotising enterocolitis in a Polish population of preterm infants: a diagnostic test accuracy study protocol. BMJ Open. 2020 Jul 20;10(7):e033519. doi: 10.1136/bmjopen-2019-033519.
PubMed 32690727
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
- ClinicalTrials.gov ID
- NCT03188380
- Acronym / sponsor ID
- KAROWA USG VERSION 1.0
- Conditions
- Necrotising Enterocolitis
- Keywords
- nec, abdominal ultrasound, abdominal radiograph, preterm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Jagiellonian University, Ujastek Obstetrics and Gynaecology Hospital, University Children's Hospital of Cracow
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Jun 2017 (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.
Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%.
Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in expediting diagnosis and management of NEC.
Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks.
Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain abdominal radiograph (AR) | – | Diagnostic Test: Plain abdominal radiography, Diagnostic Test: Abdominal ultrasoundAfter meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine. |
| Abdominal ultrasound (AUS) | – | Diagnostic Test: Plain abdominal radiography, Diagnostic Test: Abdominal ultrasoundIf plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In this single-gate study we plan to include all consecutive preterm infants (born at <32 weeks of gestation) with suspected necrotizing enterocolitis based on the presence of at least three of the above mentioned clinical symptoms 4-7:
Key inclusion criteria (15 listed)
- Abdominal distension
- Visible bowels loops
- Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of >50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis)
- Temperature instability (defined as ≥ 2 consecutive measurements)
- Frank bloody stools
Key exclusion criteria (3 listed)
- • < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound)
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 |
|---|---|---|
| Plain abdominal radiographyAfter meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine. | Diagnostic test | Abdominal ultrasound (AUS), Plain abdominal radiograph (AR) |
| Abdominal ultrasoundIf the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. | Diagnostic test | Abdominal ultrasound (AUS), Plain abdominal radiograph (AR) |
Primary outcome
Intervention time
Time frame: until 40 weeks of post-conceptional age
The time required to initiate conservative and/or surgical treatment after diagnosing NEC with AR versus AR and AUS
1 secondary outcome
Sensitivity and specificity
Time frame: until 40 weeks of post-conceptual age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 32690727Seliga-Siwecka J, Rutkowski J, Margas W, Puskarz-Gasowska J, Bokiniec R. Sensitivity and specificity of different imaging modalities in diagnosing necrotising enterocolitis in a Polish population of preterm infants: a diagnostic test accuracy study protocol. BMJ Open. 2020 Jul 20;10(7):e033519. doi: 10.1136/bmjopen-2019-033519.
- Individual participant dataSharing planned: Undecided. All de-identified data collected during the trial will be available. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
Related trials for Necrotising Enterocolitis
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Recruiting
WithHolding Enteral Feeds Around Blood Transfusion (International)
Necrotizing Enterocolitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotising Enterocolitis, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.
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 15 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanna Seliga-Siwecka, MD PhD (+48225966155, seliga.joanna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention time (time frame: until 40 weeks of post-conceptional age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188380, which also lists 1 linked publication.
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 14 May 2020.