Intestinal ObstructionOINNCT07434596
Neonatal Intestinal Obstruction: Prenatal Factors and Postnatal Outcomes
An observational study of Intestinal Obstruction, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Intestinal Obstruction
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study 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.
Who may be able to join
- Neonates from singleton pregnancies with prenatal ultrasound suspicion of intestinal obstructive pathology
- Availability of complete postnatal follow-up data
Who cannot join
- Missing delivery data
- Missing prenatal ultrasound data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neonatal Intestinal Obstruction: A Retrospective Observational Study on Prenatal Prognostic 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.
Read more
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.
- Conditions
- Intestinal Obstruction
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth up to 28 days of life
Secondary 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.
Measured: From birth up to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start11 Mar 2025
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Morabito, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434596
- Sponsor's protocol ID
- OIN
- Acronym
- OIN
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Intestinal Obstruction: A Retrospective Observational Study on Prenatal Prognostic Factors and Postnatal Outcomes
- ClinicalTrials.gov ID
- NCT07434596
- Acronym / sponsor ID
- OIN / OIN
- Conditions
- Intestinal Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study 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.
Key inclusion criteria (2 listed)
- Neonates from singleton pregnancies with prenatal ultrasound suspicion of intestinal obstructive pathology
- Availability of complete postnatal follow-up data
Key exclusion criteria (2 listed)
- Missing delivery data
- Missing prenatal ultrasound data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Incidence of Prenatal Ultrasound Findings in Neonates With and Without Confirmed Intestinal Obstruction
Time frame: From birth up to 28 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Obstruction, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonino Morabito (390555662545, antonino.morabito@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Prenatal Fetal Bowel Diameter for Predicting Postnatal Intestinal Obstruction (time frame: From birth up to 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.