Skip to main content
Clinical Trials/NCT02383264
NCT02383264CompletedNot Applicable

Splanchnic Oxygenation Patterns in Response to the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance and Correlation With Abnormal Antenatal Doppler.

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country61 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
1
Primary Endpoint
Increase/reduction of abdominal rSO2 values after the first enteral feed in infants at high risk of feeding intolerance.

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Day to 30 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Gestational age ≤34 weeks
  • Stable clinical conditions

Exclusion Criteria

  • Any 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 first feed.
  • Antenatal Doppler impairment.

Outcomes

Primary Outcomes

Increase/reduction of abdominal rSO2 values after the first enteral feed in infants at high risk of feeding intolerance.

Time Frame: 3.5 hours

Increase/reduction of abdominal rSO2 values in response to the first enteral feed in infants who have further developed feeding intolerance during their hospitalization.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luigi Corvaglia

Associate Professor, University of Bologna (Italy)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Sites (1)

Loading locations...

Similar Trials

Splanchnic Oxygenation After the First... | Clinical Trial