Aou Meyer IRCSS
Florence, 50139, Italy
Location status: Recruiting
NCT Number: NCT07434596
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.
Interested in participating?
Request Info0 day–28 day
All sexes
Observational
Florence, 50139, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Meyer Children's Hospital IRCCS
Other
Neonatal Intestinal Obstruction: A Retrospective Observational Study on Prenatal Prognostic Factors and Postnatal Outcomes
Acronym: OIN
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.
Published trials that share one or more normalized conditions with this study.
NCT07705139
Bowel Sounds, Colonic Diseases
Wuhan, Hubei, China
View Trial DetailsNCT06072976
Colonic Diseases, Congenital Abnormalities
Seattle, Washington, United States
View Trial DetailsNCT07650461
Digestive System Diseases, Emergency Laparotomy
Muzaffargarh, Punjab Province, Pakistan
View Trial DetailsNCT07432542
Colorectal Neoplasms, Digestive System Diseases
Guangzhou, Guangdong, China
View Trial Details