Placental Insufficiency Clinical Trial
Official title:
Splanchnic Oxygenation and Perfusion Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler: Pattern Assessment and Correlation With Feeding Intolerance
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.
Intrauterine growth restriction (IUGR) is a major cause of perinatal morbidity and
mortality. Severe IUGR is often due to impaired placental circulation, with absent or
reversed end-diastolic flow (AREDF) velocity through the umbilical arteries. Fetuses with
AREDF adapt to chronic hypoxia by undergoing a blood flow redistribution, which favors
cerebral perfusion at the expense of the mesenteric district. The resulting hypoxic-ischemic
injury of the intestinal mucosa represents a major risk factor for the post-natal
development of gastrointestinal complications, such as necrotizing enterocolitis (NEC),
spontaneous intestinal perforation (SIP) and feeding intolerance (FI). Due to the fear of
the aforementioned conditions, the establishment of adequate enteral feeding in AREDF
preterm infants is often difficult; hence, the identification of infants at highest risk for
GI complications could aid their delicate nutritional management.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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