Preterm Infants Clinical Trial
— ECUN
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in
premature infants.
The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to
date is the reference examination to confirm or refute the diagnosis. Indeed, the presence
of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the
diagnosis. The prognostic value of these radiographic findings is currently controversial.
Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began
to be considered for some years. It also has other advantages, including that of not being a
radiating examination. Studies on the prognostic value of abdominal ultrasound are rather
few. Moreover, they involve a series of heterogeneous patients in terms of gestational age.
Or the pathophysiology of ECUN in children born at term and in children born prematurely is
not the same.
The objective is to study prospectively the prognostic contribution of abdominal ultrasound
in the ECUN in premature under 33SA.
Status | Not yet recruiting |
Enrollment | 95 |
Est. completion date | April 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 33 Weeks |
Eligibility |
Inclusion Criteria: - Birth Term strictly less than 33SA - Gestational age some (assessed on early ultrasound dating) - Congenital malformation of Absence - Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic) - Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN - Maximum interval between imaging tests 2 hours - No parental opposition to the participation of children in the study Exclusion Criteria: - Term higher or equal to 33 weeks - Congenital malformation - Parental Opposition (or legal representatives) to participate in the study |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hôpitaux de Marseille | Marseille |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comment prognostic evaluation by abdominal ultrasound | Assessment in clinical outcome prognosis by abdominal ultrasound | 36 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02159534 -
Primebrain Stimulation
|
N/A | |
Recruiting |
NCT01813682 -
Effect of Iron-fortified TPN on Preterm Infants Anemia
|
N/A | |
Not yet recruiting |
NCT01615523 -
Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function
|
N/A | |
Completed |
NCT02103777 -
High Versus Low Dose of Caffeine for Apnea of Prematurity
|
Phase 3 | |
Recruiting |
NCT06201962 -
Effect of Massage and Foot Reflexology on Newborns' Sleep
|
N/A | |
Completed |
NCT05230706 -
Light/Dark Cycle Promotes Weight Gain in Preterm Infants
|
N/A | |
Recruiting |
NCT05138276 -
Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
|
Early Phase 1 | |
Terminated |
NCT01430832 -
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
|
||
Recruiting |
NCT01786759 -
Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion
|
Phase 4 | |
Completed |
NCT00838474 -
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
|
N/A | |
Completed |
NCT05656677 -
Parental Involvement in Pain Reducing Measures
|
N/A | |
Active, not recruiting |
NCT01487187 -
The Effect of Cord Milking on Hemodynamic Status of Preterm Infants
|
N/A | |
Completed |
NCT00838188 -
Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
|
N/A | |
Recruiting |
NCT03121781 -
Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula
|
N/A | |
Completed |
NCT02770976 -
Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants
|
N/A | |
Completed |
NCT01841268 -
Skin Lipid Profiles in Term and Preterm Infants
|
||
Not yet recruiting |
NCT00320840 -
Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants
|
N/A | |
Completed |
NCT00707837 -
Nutritional Study in Preterm Infants
|
Phase 3 | |
Completed |
NCT01083303 -
Weaning Preterm Infants at 1500 Grams From Incubators
|
N/A | |
Recruiting |
NCT03631264 -
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
|
N/A |