Neonatal Intestinal Obstruction: A Retrospective Observational Study on Prenatal Prognostic Factors and Postnatal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal Obstruction
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates from singleton pregnancies with prenatal ultrasound suspicion of intestinal obstructive pathology
- •Availability of complete postnatal follow-up data
排除标准
- •Missing delivery data
- •Missing prenatal ultrasound data
研究组 & 干预措施
Normal Postnatal Gastrointestinal Function
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.
Neonates with confirmed postnatal intestinal obstruction
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.
结局指标
主要结局
Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal Obstruction
时间窗: 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.
次要结局
- Incidence of Prenatal Ultrasound Findings in Neonates With and Without Confirmed Intestinal Obstruction(From birth up to 28 days of life)
研究者
Antonino Morabito
Principal Investigator
Meyer Children's Hospital IRCCS