Necrotizing Enterocolitis Clinical Trial
Official title:
Splanchnic Oxygenation Patterns in Response to the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance and Correlation With Abnormal Antenatal Doppler.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a
challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm
infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis
(NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence
of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the
establishment of an adequate early enteral nutrition is frequently hampered. Early
identification of preterm infants at high risk for gastrointestinal complications could help
clinical decisions on the introduction and the advancement of enteral feeding.
Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen
saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the
first week of life and subsequent NEC development has been reported. To date, however,
splanchnic oxygenation patterns in response to the first bolus feed and possible
correlations with subsequent FI development have not been yet established.
This observational prospective study aims:
- to assess abdominal rSO2 patterns in response to the first bolus feed;
- to evaluate possible correlations with subsequent development of gastrointestinal
complications.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants remains a
major challenge for neonatologists. Early introduction of minimal enteral feeding (MEF)
enhances gut hormones release, reduces the intestinal permeability and improves the motility
of the intestinal tract, thus promoting gut functional maturation. Due to gastrointestinal
immaturity, however, preterm infants are likely to develop clinical symptoms of feeding
intolerance (FI), such as abdominal distention, vomiting, abundant and/or bilious gastric
residuals, occult or gross bloody stools. FI could represent an early sign of necrotizing
enterocolitis (NEC), the most feared gastrointestinal complication of prematurity. The
occurrence of FI often prompts neonatologists to withhold, decrease or discontinue enteral
feeds, thus hampering the establishment of an adequate early enteral nutrition.
Early identification of preterm infants at high risk of gastrointestinal complications could
help clinical decisions on the introduction and the advancement of enteral feeding. The
administration of the first feed in healthy preterm infants leads to a post-prandial
increase of superior mesenteric artery (SMA) blood flow, detected by Doppler ultrasound. A
significant correlation between early feeding tolerance and increased SMA blood flow
velocity has been further observed one hour after the first feed.
Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen
saturation (rSO2) and has been previously used to evaluate mesenteric perfusion in preterm
infants at increased risk for intestinal complications. Abdominal rSO2 detected by NIRS has
been shown to effectively reflect mesenteric blood flow changes. A significant correlation
between lower abdominal rSO2 values in the first week of life and subsequent NEC development
has been recently observed in a cohort of preterm infants, confirming previous data from
animal models.
Current evidences on the role of NIRS monitoring in predicting FI development are still
limited. To date, indeed, splanchnic oxygenation patterns in response to the first bolus
feed and possible correlations with subsequent FI development have not been established yet.
The aim of this study is to assess abdominal rSO2 patterns in response to the first bolus
feed and to evaluate possible correlations 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, availability of antenatal Doppler data.
Exclusion criteria are:
- Enteral feeding prior to the enrollment
- Major congenital abnormalities
- Central nervous system diseases
- Hypoxic injury
- Hemodynamic instability, hypotension, patent ductus arterioles, anemia, sepsis or other
infections at time of the first feed.
- Antenatal Doppler impairment.
Written, informed consent to participate in the study is obtained from the parents/legal
guardians of each infant before enrollment.
During the first feed administration, the enrolled infants undergo a continuous monitoring
of cerebral and splanchnic rSO2 by means of an INVOS 5100 oximeter. NIRS recording is
performed from 30 minutes before to 3 hours after feeding administration. Cerebral and
splanchnic rSO2 are recorded every 5 seconds. Baseline values are defined by the mean of the
15 minutes before the meal; values recorded after feeding administration are clustered into
5-minute intervals.
Feeding intolerance is defined as enteral feeding withholding for at least 1 day due to the
onset of gastrointestinal symptoms.
Patients' characteristics (including gestational age, birth weight, tolerance to enteral
feeds during hospitalization) are recorded in a specific case report form at the time of
enteral feeding introduction and before discharge.
In relation to their clinical characteristics, the enrolled infants are retrospectively
allocated into 2 groups:
- Group 1: infants developing FI during the hospitalization;
- Group 2: infants not developing FI during the hospitalization;
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 t-test for continuous variables and chi-square test for categorical variables.
Mann-Whitney U test is used to compare abdominal rSO2 patterns in response to the first feed
between groups 1 and 2. A multivariate analysis is also performed to assess the effect of
possible confounding factors.
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Observational Model: Case Control, Time Perspective: Prospective
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