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NCT Number: NCT07434596

Neonatal Intestinal Obstruction: Prenatal 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.

Recruiting

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Aou Meyer IRCSS

Florence, 50139, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal Obstruction

    Time frame: From birth up to 28 days of life

    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.

Secondary outcomes

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

    Time frame: From birth up to 28 days of life

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonino Morabito

CONTACT

[email protected]

390555662545

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

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

Acronym: OIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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