Feeding Intolerance in PretermNCT06874153
Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance Using Fecal Lipocalin-2 and Electrical Cardiometry
An observational study of Feeding Intolerance in Preterm and NEC, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Feeding Intolerance in Preterm, NEC, Electrical Cardiometry
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2025to 5 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance
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
Read the 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.
- Keywords
- preterm, NEC, Electrical Cardiometry, SMA flow, feeding intolerance in preterm, Fecal lipocalin-2
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (2)
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
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start5 Mar 2025 (estimated)
- Primary completion5 Mar 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding Intolerance in PretermStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sayed Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874153
- Sponsor's protocol ID
- NEC prediction in preterm
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Prediction of Necrotizing Enterocolitis in Preterm Neonates with Feeding Intolerance
- ClinicalTrials.gov ID
- NCT06874153
- Acronym / sponsor ID
- NEC prediction in preterm
- Keywords
- preterm, NEC, Electrical Cardiometry, SMA flow, feeding intolerance in preterm, Fecal lipocalin-2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (estimated)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Intolerance in Preterm and NEC, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed s Hassan, assistant lecturer (+201096997827, dr.mohamedsayedhassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical cardiometry for prediction of NEC in preterm neonates with feeding intolerance (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.