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NCT Number: NCT06874153

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

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

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Ain Shams university.

Cairo, Abbasia, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance

    Time frame: 48 hours

    low cardiac output measured by electrical cardiometry predict NEC in preterm with feeding intolerance

Secondary outcomes

  1. Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance

    Time frame: 48 hours

    High level of lipocalin-2 in stool sample predict NEC in preterm neonates with feeding intolerance

  2. SMA flow in prediction of NEC in preterm neonates with feeding intolerance

    Time frame: 48 hours

    low flow through SMA predict NEC in preterm neonates with feeding intolerance

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed s Hassan, assistant lecturer

CONTACT

[email protected]

+201096997827

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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