Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
NCT ID: NCT02383264
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
61 participants
OBSERVATIONAL
2013-02-28
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
feeding intolerance
Development of feeding intolerance, defined as enteral feeding withholding for at least 1 day due to the onset ofgastrointestinal clinical symptoms
No interventions assigned to this group
normal feeding tolerance
no evidence of feeding intolerance during the hospitalization
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stable clinical conditions
Exclusion Criteria
* 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.
1 Day
30 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luigi Corvaglia
Associate Professor, University of Bologna (Italy)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luigi T Corvaglia, Prof
Role: PRINCIPAL_INVESTIGATOR
S. Orsola-Malpighi Hospital, University of Bologna
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neonatal Intensive Care Unit of the S.Orsola-Malpighi Hospital
Bologna, Italy, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Corvaglia L, Martini S, Battistini B, Rucci P, Faldella G, Aceti A. Splanchnic Oxygenation at First Enteral Feeding in Preterm Infants: Correlation With Feeding Intolerance. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):550-554. doi: 10.1097/MPG.0000000000001308.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
122/2012/U/Oss
Identifier Type: OTHER
Identifier Source: secondary_id
SO-2015-NIRS
Identifier Type: -
Identifier Source: org_study_id