Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes
ConditionIntestinal Obstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorMeyer Children's Hospital IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates from singleton pregnancies with prenatal ultrasound suspicion of intestinal obstructive pathology
Availability of complete postnatal follow-up data
Disqualifiers
Missing delivery data
Missing prenatal ultrasound data
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Neonates with confirmed postnatal intestinal obstruction
Group B: Normal Postnatal Gastrointestinal Function
Trial outcomes
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.
Time frame
From birth up to 28 days of lifeSecondary outcomes
1
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 lifeSponsors and contacts
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Source ClinicalTrials.gov