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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Necrotizing Enterocolitis; Intestinal Atresia; Hirschsprung Disease; Malrotation

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 Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 informed consent obtained from parent(s) or legal guardian(s)

Exclusion Criteria:

• Other gastrointestinal problems not requiring urgent intervention

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 28 days (hospital stay)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Proportion of neonates who die during hospitalization	Up to 28 days (hospital stay
Length of Hospital Stay	Duration of hospitalization in days from NICU admission until discharge or death	From admission to discharge, up to 28 days
Requirement for surgical intervention	The proportion of neonates requiring surgical management among the enrolled cases.	During hospitalization, up to 28 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: NICU; Neonate; Intestinal obstruction; Gastrointestinal emergency
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Congenital Abnormalities; Digestive System Abnormalities; Enterocolitis; Megacolon; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intestinal Obstruction; Enterocolitis, Necrotizing; Hirschsprung Disease; Intestinal Atresia; Volvulus Of Midgut
• Other Study ID Numbers: AUCH-NGIT-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No