ClinicalTrials.gg
Not yet recruitingNCT07526636Updated Apr 13, 2026

Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital

An observational study in Necrotizing Enterocolitis, Intestinal Atresia and Malrotation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Minute to 28 Days. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
1 Minute to 28 Days
Sex
All
01

Study summary

This prospective observational study aims to evaluate the pattern, clinical presentation, complications, and short-term outcomes of neonates admitted with gastrointestinal emergencies to the NICU at Assiut University Children Hospital. Data will be collected from admission through discharge, including demographic, antenatal, natal, clinical, nutritional, laboratory, and radiological information, to identify the most common emergencies and factors associated with adverse outcomes.

Read the detailed description

This prospective observational cohort study will be conducted at the Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital. The study aims to evaluate the pattern, clinical presentation, complications, and short-term outcomes of neonatal gastrointestinal emergencies.

Eligible neonates will be enrolled consecutively from admission until discharge. Both term and preterm neonates will be included. Data will be systematically collected on demographic characteristics, antenatal and natal history, clinical presentation, feeding practices, laboratory investigations, and radiological findings.

Management approaches, including medical and surgical interventions, will be documented. Patients will be followed throughout their hospital stay to assess outcomes, including recovery, complications, need for surgical intervention, and mortality.

The study also aims to identify the most common types of gastrointestinal emergencies and determine the clinical and demographic factors associated with adverse outcomes among affected neonates.

02

Conditions studied

  • Necrotizing Enterocolitis
  • Intestinal Atresia
  • Malrotation
  • Hirschsprung Disease

Keywords

  • Neonate
  • NICU
  • Gastrointestinal emergency
  • Intestinal obstruction
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 120 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.

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

04

Who can participate

Ages eligible
1 Minute to 28 Days
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Neonates admitted to the NICU at Assiut University Children Hospital with gastrointestinal emergencies, including both term and preterm infants from 28 weeks gestational age, observed from admission through discharge.

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

  • Neonates aged 0-28 days (corrected age if preterm)
  • Admitted to the NICU with a clinical diagnosis of a gastrointestinal emergency requiring urgent intervention
  • Written obtained from parent(s) or legal guardian(s)

Exclusion criteria

Exclusion Criteria:

  • Other gastrointestinal problems not requiring urgent intervention
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of the most common gastrointestinal emergencies among neonates admitted to the NICU

    The prevalence of each type of neonatal gastrointestinal emergency will be calculated as the proportion of cases among all enrolled neonates admitted to the NICU during the study period. Diagnoses will be based on clinical, laboratory, and radiological findings.

    Time frame: Up to 28 days (hospital stay)

Secondary outcomes

  1. Mortality Rate

    Proportion of neonates who die during hospitalization

    Time frame: Up to 28 days (hospital stay

  2. Length of Hospital Stay

    Duration of hospitalization in days from NICU admission until discharge or death

    Time frame: From admission to discharge, up to 28 days

  3. Requirement for surgical intervention

    The proportion of neonates requiring surgical management among the enrolled cases.

    Time frame: During hospitalization, up to 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07526636
Lead sponsor
Assiut University
Responsible party
Nourhan Osama Hassan Abdellatif (Resident Of Pediatrics, Assiut University) — Principal investigator
First posted
Apr 13, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 13, 2026

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 Apr 2026. You cannot join it, but the record below documents what was studied.

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