Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes

NCT07434596 | Recruiting

• 1 other identifier: OIN
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intestinal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Prenatal Ultrasound Findings in Neonates With and Without Confirmed Intestinal Obstruction

  From birth up to 28 days of life

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Missing delivery data
• Missing prenatal ultrasound data

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Aou Meyer IRCSS

Florence, Florence, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Antonino Morabito

CONTACT

390555662545; antonino.morabito@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 25, 2026
• Study Start: March 11, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

IT (1)