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

NCT ID: NCT06874153

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2026-06-05

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sayed Hassan

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Ain Shams university.

Cairo, Abbasia, Egypt

Countries

Egypt

Central Contacts

Mohamed s Hassan, assistant lecturer

Role: CONTACT

dr.mohamedsayedhassan@gmail.com

+201096997827

Other Identifiers

NEC prediction in preterm

Identifier Type: -

Identifier Source: org_study_id