Skip to content

Association between hyponatremia and severe Necrotising enterocolitis in newborn infants

Cohort study on hyponatremia and risk for bowel ischemia or death in infants with Necrotising enterocolitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000219785
Acronym
NaNEC
Enrollment
89
Registered
2022-02-08
Start date
2020-03-02
Completion date
2020-11-05
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our hypothesis is that a drop in plasmatic sodium at the onset of necrotising enterocolitis in neonates is associated with higher risk of ischemic/perforated bowel and therefore with the severity of the disease. We are going to performed a retrospective cohort study. We are going to collect data on patients who developed necrotising enterocolitis from 2009-2014 in SLL.. Patients' records are examined, based on established clinical and radiological criteria, to check the accuracy of the diagnosis. NEC diagnosis was based on clinical signs plus the presence of intramural gas/portal gas on abdominal radiographs and/or histological evidence of NEC. Infants with uncertain diagnosis of NEC (Bell´s stage <II) were not considered having NEC. We are going to collect data from blood samples on metabolic status ( sodium, creatinine, lactate, glucose) from a 3 days before diagnosis NEC to surgery because of NEC from journal charts. We are going to calculate the sodium difference ( = plasmatic sodium from 1-3 days before diagnosis – plasmatic sodium at first symptoms). Primary outcome: To assess if sodium difference is associated with severe NEC (bowel necrosis/perforation and/or death because of NEC in 14 days from symptoms) Secondary outcome: To assess if sodium difference is associated with severe NEC (bowel necrosis/perforation and/or death because of NEC in 14 days from symptoms) in infants without radiological indication for surgery (pneumoperitoneum). Results are going to be presented as odds ration

Interventions

The presence of plasmatic hyponatremia or a decrease in plasmatic sodium at first symptoms in infants with Necrotising enterocolitis during their staying in the neonatal ward. Retrospective cohort study, no active participation, only data from medical records collected for the study. All patients from the Stockholm County who received a NEC diagnosis (P77.9 according to ICD-10) from 1st of January 2009 to 31st of December 2014 were identified in the Swedish Neonatal Quality Register (SNQ). All

The presence of plasmatic hyponatremia or a decrease in plasmatic sodium at first symptoms in infants with Necrotising enterocolitis during their staying in the neonatal ward. Retrospective cohort study, no active participation, only data from medical records collected for the study. All patients from the Stockholm County who received a NEC diagnosis (P77.9 according to ICD-10) from 1st of January 2009 to 31st of December 2014 were identified in the Swedish Neonatal Quality Register (SNQ). All infants who present with Necrotising enterocolitis will be assessed for 2 weeks from NEC diagnosis. Patients' records are examined, based on established clinical and radiological criteria, to check the accuracy of the diagnosis. NEC diagnosis was based on clinical signs plus the presence of intramural gas/portal gas on abdominal radiographs and/or histological evidence of NEC.

Sponsors

Karolinska University Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
2 Days to 90 Days
Healthy volunteers
No

Inclusion criteria

_Patients from the Stockholm County Council (SLL) who received NEC diagnosis, ICD-10 P77.9 A-X, from 2009 through 2014 are eligibile for the study - Only Patients with a confirmed NEC diagnosis (based on clinical signs plus the presence of intramural gas/portal gas on abdominal radiographs and/or histological evidence of NEC) were included.

Exclusion criteria

- Infants with uncertain diagnosis of NEC (Bell´s stage <II) were not considered having NEC and excluded from the study - infants with major abdominal malformations

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026