Clinical trial NCT03188380: Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
Official title: The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotising Enterocolitis
Keywords: nec
abdominal ultrasound
abdominal radiograph
preterm
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: Ujastek Obstetrics and Gynaecology Hospital
name: University Children's Hospital of Cracow
First posted: 2017-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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:

Brief 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%.

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.


Eligibility criteria: Inclusion Criteria:

* 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/')
* 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

Exclusion Criteria:

* • \< 22 weeks of gestational age or \> 32 weeks (estimated by ultrasound)

  * Congenital abnormalities
  * No parental consent

Primary outcomes:
measure: Intervention time
timeFrame: until 40 weeks of post-conceptional age
Secondary outcomes:
measure: Sensitivity and specificity
timeFrame: until 40 weeks of post-conceptual age
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Study officials:
References:
citation: 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.