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

NCT06874153 | Not Yet Recruiting

• 1 other identifier: NEC prediction in preterm
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

preterm; NEC; Electrical Cardiometry; SMA flow; feeding intolerance in preterm; Fecal lipocalin-2

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (2)

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

  48 hours

• SMA flow in prediction of NEC in preterm neonates with feeding intolerance

  48 hours

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine, Ain Shams university.

Cairo, Abbasia, 11517, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Mohamed s Hassan, assistant lecturer

CONTACT

+201096997827; dr.mohamedsayedhassan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 13, 2025
• Study Start: March 5, 2025
• Primary Completion: March 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

EG (1)