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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
Sponsor:
Information provided by (Responsible Party):
Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Gastrointestinal complications

Development of one ore more of the following gastrointestinal complications:

  • necrotizing enterocolitis (stage ≥2)
  • spontaneous intestinal perforation
  • feeding intolerance, defined as enteral feeding withholding ≥1 day because of suggestive clinical signs
Controls
no evidence of gastrointestinal complications during the hospitalization



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 preterm infants admitted to the Neonatal Intensive Care Unit of Sant'Orsola-Malpighi University Hospital and fulfilling the inclusion criteria are going to be enrolled.
Criteria

Inclusion Criteria:

  • gestational age ≤34 weeks
  • stable clinical conditions
  • documented evidence of antenatal umbilical Doppler impairment
  • written informed consent obtained from parents/guardians

Exclusion Criteria:

  • Enteral feeding prior to the enrollment
  • Major congenital abnormalities (including congenital heart diseases, gastroschisis, exomphalos)
  • Hemodynamic instability, hypotension, patent ductus arteriosus, anemia, sepsis or other infections at time of NIRS monitoring

Information from the National Library of Medicine

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


Locations
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Italy
Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
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Principal Investigator: Luigi T Corvaglia, Prof Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luigi Corvaglia, Associate Professor, University of Bologna (Italy), Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02971566    
Other Study ID Numbers: SO-2016-AREDF
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
feeding intolerance
preterm infants
near infrared spectroscopy
abnormal antenatal Doppler
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Placental Insufficiency
Feeding and Eating Disorders
Pregnancy Complications
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mental Disorders
Placenta Diseases