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Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07434596
Acronym
OIN
Enrollment
60
Registered
2026-02-25
Start date
2025-03-11
Completion date
2026-12-01
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Obstruction

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.

Interventions

None listed

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal ObstructionFrom birth up to 28 days of lifeDetermination 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.

Secondary

MeasureTime frameDescription
Incidence of Prenatal Ultrasound Findings in Neonates With and Without Confirmed Intestinal ObstructionFrom birth up to 28 days of lifePercentage 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.

Countries

Italy

Contacts

CONTACTAntonino Morabito
antonino.morabito@unifi.it390555662545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026