An observational study in Intestinal Obstruction, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 1 site in Italy. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Meyer Children's Hospital IRCCS · Observational
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.
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's planned enrollment of 60 is below the median of 107 across 40 observational studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Time frame: From birth up to 28 days of life
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.
Time frame: From birth up to 28 days of life
Started Mar 2025 (actual). Primary completion is estimated for Apr 2026, 13 months after the start.
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