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

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

Study Overview

• Status: Not yet recruiting
• Conditions: PreTerm Neonate; NEC; Electrical Cardiometry; Feeding Intolerance in Preterm

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.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Mohamed s Hassan, assistant lecturer; Phone Number: +201096997827; Email: dr.mohamedsayedhassan@gmail.com

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11517
      • Faculty of Medicine, Ain Shams University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

feeing intolerance group; Preterm neonates with gestational age ≤ 35 weeks, admitted to the NICU, started enteral feeding and were diagnosed as having feeding intolerance defined as stages IA and IB by modified bell's staging. Measuring superior mesenteric artery will be done on day 1 of diagnosis of feeding intolerance Cardiac output and delivery of oxygen to tissues (do2) will be measured on day 1 of the diagnosis of feeding intolerance, and follow-up will be done after 24 hours by electrical bioimpedance. Fecal Lipocalin-2 assessment in Stool sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance	low cardiac output measured by electrical cardiometry predict NEC in preterm with feeding intolerance	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance	High level of lipocalin-2 in stool sample predict NEC in preterm neonates with feeding intolerance	48 hours
SMA flow in prediction of NEC in preterm neonates with feeding intolerance	low flow through SMA predict NEC in preterm neonates with feeding intolerance	48 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2025
• Primary Completion (Estimated): March 5, 2026
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: preterm; NEC; Electrical Cardiometry; SMA flow; feeding intolerance in preterm; Fecal lipocalin-2
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Premature Birth; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: NEC prediction in preterm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No