Clinical trial NCT06874153: Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
Official title: Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Feeding Intolerance in Preterm
NEC
Electrical Cardiometry
PreTerm Neonate
Keywords: preterm
NEC
Electrical Cardiometry
SMA flow
feeding intolerance in preterm
Fecal lipocalin-2
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance
timeFrame: 48 hours
Secondary outcomes:
measure: Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance
timeFrame: 48 hours
measure: SMA flow in prediction of NEC in preterm neonates with feeding intolerance
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Ain Shams university.
state: Abbasia
Study officials:
References: