NCT07526636

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

April 3, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

NeonateNICUGastrointestinal emergencyIntestinal obstruction

Outcome Measures

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.

    Up to 28 days (hospital stay)

Secondary Outcomes (3)

  • Mortality Rate

    Up to 28 days (hospital stay

  • Length of Hospital Stay

    From admission to discharge, up to 28 days

  • Requirement for surgical intervention

    During hospitalization, up to 28 days

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Other gastrointestinal problems not requiring urgent intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Enterocolitis, NecrotizingIntestinal AtresiaVolvulus Of MidgutHirschsprung DiseaseIntestinal Obstruction

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMegacolonColonic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Of Pediatrics

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 13, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04