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Not yet recruitingNCT06632041Updated Oct 10, 2024

Necrotizing Enterocolities

An observational study in Necrotizing Enterocolitis of Newborn, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
1 Day to 30 Days
Sex
All
01

Study summary

Haematological disturbances in neonates with necrotizing enterocolities

Read the detailed description

Necrotizing enterocolitis (NEC) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. With an incidence of about 7% in infants with BW \< 1500 g and mortality up to 30%, NEC presents as a medical and surgical emergency It is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. While exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis

  • in this devastating disease with undetermined etiology. Breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in NEC
  • The hematological abnormalities associated with NEC were first described 25 years ago by Hutter et al.The abnormalities observed in a series of 40 patients with NEC included thrombocytopenia, with
  • and without disseminated intravascular coagulation (DIC), neutrophilia or neutropenia, and hemolytic anemia.
02

Conditions studied

  • Necrotizing Enterocolitis of Newborn
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 70 is below the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neonates with necrotizing enterocolities

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • preterm less than 36 weeks
  • Or very low birth weight less than 1500 gram

Exclusion criteria

Exclusion Criteria:

  • full term
  • Normal birth weight ,Preterm with early breast feeding or more than 1500 gm
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neonates with necrotizing enterocolities

    Diagnostic Test: Complete blood count · Other: Complete blood count

Interventions

  • Diagnostic testComplete blood count

    Study haemtological disturbances in neonates with necrotizing enterocolities

  • OtherComplete blood count

    Haemtological disturbances in neonates with necrotizing enterocolities

06

What researchers measure

Primary outcomes

  1. Aim

    :to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Nov 2025, 10 months later.

Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2024
First posted
Oct 8, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
Nov 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06632041
Lead sponsor
Assiut University
Responsible party
Mervat maher saad zakhary (Principal investigator, Assiut University) — Principal investigator
First posted
Oct 8, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

Mervat Maher Zakhary
Contact
mahersaaad56@gmail.com
01026767826

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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