Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler.
NCT ID: NCT02971566
Last Updated: 2016-11-23
Study Results
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Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2013-02-28
2016-10-31
Brief Summary
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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.
Detailed Description
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Postnatal Doppler studies have shown a decreased blood flow velocity in the superior mesenteric artery in response to the first enteral feed in AREDF preterm infants who later developed feeding intolerance. A similar Doppler impairment and lower values of splanchnic oxygenation at feeding introduction have been described in non-IUGR preterm infants with later GI complications. To date, however, it is not known whether the impaired mesenteric blood flow observed after the first feed in high-risk AREDF infants persists over time, or if it correlates with reduced splanchnic oxygenation and perfusion.
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.
Infants admitted to the Neonatal Intensive Care Unit (NICU) are consecutively enrolled in the study if fulfilling the following criteria: gestational age ≤34 weeks, stable clinical conditions, documented evidence of antenatal umbilical Doppler impairment.
Exclusion criteria are:
* 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
Written, informed consent to participate in the study is obtained from the parents/legal guardians of each infant before enrollment.
Enrolled infants undergo a continuous monitoring of splanchnic oxygenation (SrSO2) at enteral feeding introduction (15 ml/kg/die volumes administered within the first 48 hours of life) and full enteral feeding (FEF) achievement (enteral intake ≥150 ml/kg/die) from 30' before to 3 h after feed administration by means of INVOS 5100 oximeter (Somanetics Corporation, Troy, MI, USA).
A simultaneous monitoring of peripheral oxygen saturation (SpO2) is be performed in order to calculate splanchnic fractional oxygen extraction (SFOE) ratio (\[SpO2-SrSO2\]/SpO2). SrSO2 values recorded during hypoxic episodes (SpO2 \<85%) are excluded from statistical analysis.
GI complications are defined as NEC stage ≥2, SIP and/or FI (enteral feeding withholding ≥1 day because of suggestive clinical signs). Enrolled infants are retrospectively divided into two groups: lack (group 1) vs. development (group 2) of GI complications.
Data are analyzed using IBM SPSS Statistic version 20.0.0 (IBM Corporation, IBM Corporation Armonk, New York, United States). Clinical characteristics in the study groups are compared by Mann-Whitney U test for continuous variables and chi-square test for categorical variables. Mann-Whitney U test is used to compare abdominal SrSO2 and FSOE patterns in response to feeds between groups 1 and 2.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Controls
no evidence of gastrointestinal complications during the hospitalization
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* stable clinical conditions
* documented evidence of antenatal umbilical Doppler impairment
* written informed consent obtained from parents/guardians
Exclusion Criteria
* 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
1 Day
2 Months
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Luigi Corvaglia
Associate Professor, University of Bologna (Italy)
Principal Investigators
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Luigi T Corvaglia, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna, Italy, Italy
Countries
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References
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Kempley S, Gupta N, Linsell L, Dorling J, McCormick K, Mannix P, Juszczak E, Brocklehurst P, Leaf A; ADEPT Trial Collaborative Group. Feeding infants below 29 weeks' gestation with abnormal antenatal Doppler: analysis from a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2014 Jan;99(1):F6-F11. doi: 10.1136/archdischild-2013-304393. Epub 2013 Aug 23.
Bora R, Mukhopadhyay K, Saxena AK, Jain V, Narang A. Prediction of feed intolerance and necrotizing enterocolitis in neonates with absent end diastolic flow in umbilical artery and the correlation of feed intolerance with postnatal superior mesenteric artery flow. J Matern Fetal Neonatal Med. 2009 Nov;22(11):1092-6. doi: 10.3109/14767050903029600.
Kempley ST, Gamsu HR, Vyas S, Nicolaides K. Effects of intrauterine growth retardation on postnatal visceral and cerebral blood flow velocity. Arch Dis Child. 1991 Oct;66(10 Spec No):1115-8. doi: 10.1136/adc.66.10_spec_no.1115.
Martini S, Aceti A, Beghetti I, Faldella G, Corvaglia L. Feed-related Splanchnic Oxygenation in Preterm Infants With Abnormal Antenatal Doppler Developing Gut Complications. J Pediatr Gastroenterol Nutr. 2018 May;66(5):755-759. doi: 10.1097/MPG.0000000000001804.
Other Identifiers
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SO-2016-AREDF
Identifier Type: -
Identifier Source: org_study_id