Necrotizing EnterocolitisNCT07526636
Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital
An observational study of Necrotizing Enterocolitis and Intestinal Atresia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Necrotizing Enterocolitis, Intestinal Atresia, Malrotation
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Apr 2027
- 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 minute to 28 days
- All sexes
- Child
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.
Who may be able to join
- 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 informed consent obtained from parent(s) or legal guardian(s)
Who cannot join
- Other gastrointestinal problems not requiring urgent intervention
About this study
Official title: Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital: A Prospective Observational Cohort Study
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.
- Keywords
- Neonate, NICU, Gastrointestinal emergency, Intestinal obstruction
- Medical subject headings
- Enterocolitis, Necrotizing, Intestinal Atresia, Volvulus Of Midgut, Hirschsprung Disease, Intestinal Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days (hospital stay)
Secondary outcomes (3)
Mortality Rate
Proportion of neonates who die during hospitalization
Measured: Up to 28 days (hospital stay
Length of Hospital Stay
Duration of hospitalization in days from NICU admission until discharge or death
Measured: From admission to discharge, up to 28 days
Requirement for surgical intervention
The proportion of neonates requiring surgical management among the enrolled cases.
Measured: During hospitalization, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Osama Hassan Abdellatif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526636
- Sponsor's protocol ID
- AUCH-NGIT-2026
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07526636
- Acronym / sponsor ID
- AUCH-NGIT-2026
- Keywords
- Neonate, NICU, Gastrointestinal emergency, Intestinal obstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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 informed consent obtained from parent(s) or legal guardian(s)
Key exclusion criteria (1 listed)
- Other gastrointestinal problems not requiring urgent intervention
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
Prevalence of the most common gastrointestinal emergencies among neonates admitted to the NICU
Time frame: Up to 28 days (hospital stay)
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.
3 secondary outcomes
Mortality Rate
Time frame: Up to 28 days (hospital stay
Length of Hospital Stay
Time frame: From admission to discharge, up to 28 days
Requirement for surgical intervention
Time frame: During hospitalization, up to 28 days
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 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis and Intestinal Atresia, run by Assiut University.
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 3 inclusion and 1 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the most common gastrointestinal emergencies among neonates admitted to the NICU (time frame: Up to 28 days (hospital stay)). 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 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.