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

N/ANot Yet RecruitingNCT06874153

Ain Shams University42 enrolled

Overview

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

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

Conditions

Feeding Intolerance in Preterm NEC Electrical Cardiometry PreTerm Neonate

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of medicine, Ain Shams university.

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

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

Time frame: 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

Time frame: 48 hours

Central Contacts

Mohamed s Hassan, assistant lecturer

CONTACT

+201096997827 dr.mohamedsayedhassan@gmail.com

Data from ClinicalTrials.gov

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