Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Feeding Intolerance in Preterm, NEC, Electrical Cardiometry, PreTerm Neonate. Basic parameters: 1 Day — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance
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
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.
Primary outcome measures
- Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance [Time frame: 48 hours]
Secondary outcome measures (2)
- Fecal lipocalin-2 for prediction of NEC in preterm neonates with feeding intolerance [Time frame: 48 hours]
- SMA flow in prediction of NEC in preterm neonates with feeding intolerance [Time frame: 48 hours]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Faculty of medicine, Ain Shams university. — Cairo
Identifiers
NCT: NCT06874153 · NEC prediction in preterm