Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler. (AREDF-SO)
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|ClinicalTrials.gov Identifier: NCT02971566|
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing enterocolitis or spontaneous intestinal perforation. Due to the fear of the aforementioned conditions, the establishment of adequate enteral feeds is frequently hampered in this population. Previous postnatal Doppler studies have shown that AREDF preterm infants who later developed feeding intolerance have a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed; to date, however, it is not known whether this hemodynamic impairment persists over time, or if it is associated with reduced splanchnic oxygenation and perfusion, monitored by Near-infrared spectroscopy (NIRS).
This observational prospective study aims:
- to assess the patterns of abdominal oxygenation and perfusion in response to enteral feeds in AREDF preterm infants at different phases of enteral feeding establishment;
- to evaluate a possible correlation with the development of gastrointestinal complications.
|Condition or disease|
|Placental Insufficiency NEC - Necrotizing Enterocolitis Newborn, Premature Feeding Disorder Neonatal|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Splanchnic Oxygenation and Perfusion Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler: Pattern Assessment and Correlation With Feeding Intolerance|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Development of one ore more of the following gastrointestinal complications:
no evidence of gastrointestinal complications during the hospitalization
- Increase/reduction of SrSO2 after enteral feeds [ Time Frame: 3.5 hours ]Increase/reduction of SrSO2 values in response to enteral feeds in infants who have developed gastrointestinal complications during their hospitalization.
- Increase/reduction of FSOE after enteral feeds [ Time Frame: 3.5 hours ]Increase/reduction of SrSO2 values in response to enteral feeds in infants who have developed gastrointestinal complications during their hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971566
|Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital|
|Bologna, Italy, 40138|
|Principal Investigator:||Luigi T Corvaglia, Prof||Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi|