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Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry

Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06874153
Enrollment
42
Registered
2025-03-13
Start date
2025-03-05
Completion date
2026-06-05
Last updated
2025-03-13

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

Conditions

Electrical Cardiometry, Feeding Intolerance in Preterm, NEC, PreTerm Neonate

Keywords

preterm, NEC, Electrical Cardiometry, SMA flow, feeding intolerance in preterm, Fecal lipocalin-2

Brief summary

Prospective observational study to evaluate the efficiency of using electrical cardiometry in combination with fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance

Detailed description

Necrotizing enterocolitis is one of the most life-threatening conditions for premature infants in neonatal intensive care units (NICU) and is associated with severe intestinal inflammation and necrosis, which occurs in 5-16% of very low birth weight (VLBW) infants with a mortality rate of 20-50% and various long-term clinical sequelae for the survivors. Although preterm intestinal epithelium is suggested to be predisposed to an exaggerated inflammatory response to the present microbiome, impaired mesenteric perfusion inducing bowel hypoxia and ischemia is suggested to be one of the factors playing a major role in the development of NEC. Pathogenesis of NEC is multifactorial; however, one of the major factors is the disturbance in the end-organ blood flow with early hypoperfusion and hypotension, predisposing for developing NEC in preterm neonates. Electrical cardiometry (EC) is an impedance-based method that has been introduced for continuous noninvasive hemodynamic monitoring for cardiac output (CO) and DO2 in both term and preterm infants. Clinical studies have shown that abnormal perfusion in the splanchnic circulation, particularly in the superior mesenteric artery (SMA), may have a role in the development of NEC in newborns so can be used for early diagnosis and evaluation of NEC progression. Fecal lipocalin-2 (LCN2), also known as neutrophil gelatinase-associated lipocalin, is an anti-microbial molecule that was identified as a new robust biomarker for predicting NEC development in very low birth weight infants. LCN2 can predict half of the cases who will develop NEC in low birth weight preterms.

Interventions

None listed

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

Preterm neonates with gestational age ≤ 35 weeks, admitted to NICU, started enteral feeding and diagnosed as having feeding intolerance defined as stage IA and IB by modified bell's staging

Exclusion criteria

1. Chromosomal anomaly or multiple congenital malformations. 2. Patient with surgical malformation of the intestinal tract (i.e. omphalocele, gastroschisis, malrotation, intestinal atresia) 3. Patient diagnosed as hypoxic ischemic encephalopathy.

Design outcomes

Primary

MeasureTime frameDescription
Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance48 hourslow cardiac output measured by electrical cardiometry predict NEC in preterm with feeding intolerance

Secondary

MeasureTime frameDescription
Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance48 hoursHigh level of lipocalin-2 in stool sample predict NEC in preterm neonates with feeding intolerance
SMA flow in prediction of NEC in preterm neonates with feeding intolerance48 hourslow flow through SMA predict NEC in preterm neonates with feeding intolerance

Countries

Egypt

Contacts

Primary ContactMohamed s Hassan, assistant lecturer
dr.mohamedsayedhassan@gmail.com+201096997827

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026