Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes (OIN)

Neonatal Intestinal Obstruction: A Retrospective Observational Study on Prenatal Prognostic Factors and Postnatal Outcomes

Neonatal intestinal obstruction is one of the most common surgical emergencies in newborns. In some cases, signs of possible intestinal obstruction can already be detected during pregnancy through prenatal ultrasound. However, not all prenatal ultrasound findings accurately predict whether a newborn will truly have an intestinal obstruction after birth.

The purpose of this retrospective observational study is to evaluate which prenatal ultrasound findings are most strongly associated with confirmed intestinal obstruction after birth. In particular, the study aims to identify a specific cutoff value for fetal bowel dilation that best predicts postnatal intestinal obstruction. Other prenatal ultrasound features, such as excess amniotic fluid (polyhydramnios), ascites, echogenic bowel, and other abdominal findings, will also be analyzed.

The study will include newborns with a prenatal suspicion of intestinal obstruction who were evaluated at Meyer Children's Hospital between January 2016 and December 2024. Researchers will review existing medical records and ultrasound data. No additional tests or interventions will be performed for study purposes.

The results of this study may help improve prenatal counseling, optimize delivery planning in specialized centers, and support early postnatal management of newborns at risk for intestinal obstruction.

Study Overview

• Status: Recruiting
• Conditions: Intestinal Obstruction

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Antonino Morabito; Phone Number: 390555662545; Email: antonino.morabito@unifi.it

Study Locations

• Italy
  • Florence
    • Florence, Florence, Italy, 50139
      • Recruiting
      • Aou Meyer IRCSS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of neonates with prenatal ultrasound suspicion of intestinal obstruction who were evaluated at Meyer Children's Hospital (Azienda Ospedaliero Universitaria Meyer IRCCS) between January 2016 and December 2024.

The study includes newborns from singleton pregnancies with available prenatal ultrasound data and complete postnatal follow-up. All participants were managed according to standard clinical practice, and data were retrospectively collected from electronic medical records.

Description

Inclusion Criteria:

• Neonates from singleton pregnancies with prenatal ultrasound suspicion of intestinal obstructive pathology
• Availability of complete postnatal follow-up data

Exclusion Criteria:

• Missing delivery data
• Missing prenatal ultrasound data

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Neonates with confirmed postnatal intestinal obstruction; Neonates with prenatal ultrasound suspicion of intestinal obstruction and a confirmed diagnosis of intestinal obstruction after birth. Diagnosis was established based on clinical evaluation, imaging findings, and/or need for surgical intervention.
Normal Postnatal Gastrointestinal Function; Neonates with prenatal ultrasound suspicion of intestinal obstruction who showed normal gastrointestinal function after birth and did not receive a postnatal diagnosis of intestinal obstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal Obstruction	Determination of the optimal cutoff value (in millimeters) of fetal bowel diameter measured by prenatal ultrasound that predicts confirmed intestinal obstruction after birth. Diagnostic performance will be evaluated using receiver operating characteristic (ROC) curve analysis, including sensitivity, specificity, area under the curve (AUC), and Youden index.	From birth up to 28 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Prenatal Ultrasound Findings in Neonates With and Without Confirmed Intestinal Obstruction	Percentage of neonates presenting specific prenatal ultrasound findings (polyhydramnios, ascites, echogenic bowel, abnormal peristalsis, intra-abdominal calcifications, gastric dilatation, abnormal bowel content echogenicity, and fetal anemia) in the group with confirmed postnatal intestinal obstruction compared to the group without obstruction. Each ultrasound finding will be recorded as present or absent (yes/no) based on prenatal ultrasound assessment.	From birth up to 28 days of life

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: OIN

Drug and device information, study documents

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