Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-03-31

Brief Summary

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This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR

STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children).

PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).

SECONDARY ENDPOINT:

* To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
* To compare growth and nutritional status of the 2 groups by randomized arm.
* To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (\< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed.
* To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding).

DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.

INCLUSION CRITERIA

* Weight at birth ranging: 700 - 1501 grams;
* Gestational age up to 25 weeks and 6 days;
* Written informed consent from parents or guardians

EXCLUSION CRITERIA

* Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
* Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
* Pre-existing cutaneous disease not allowing the placement of the probe

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Detailed Description

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Conditions

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Infant, Very Low Birth Weight Infant Malnutrition Feeding Disorder of Infancy or Early Childhood Splanchnic Oximetry Splanchnic Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous nutrition

Group Type ACTIVE_COMPARATOR

different nutrional regimen

Intervention Type OTHER

compare bolus versus intermittent nutrition

bolus nutrition

Group Type ACTIVE_COMPARATOR

comparison of different feeding regimens

Intervention Type OTHER

compare intermittent versus bolus nutrition

Interventions

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different nutrional regimen

compare bolus versus intermittent nutrition

Intervention Type OTHER

comparison of different feeding regimens

compare intermittent versus bolus nutrition

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Weight at birth ranging: 700 - 1501 grams;
* Gestational age up to 25 weeks and 6 days;
* Written informed consent from parents or guardians.

Exclusion Criteria

* Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
* Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
* Pre-existing cutaneous disease not allowing the placement of the probe

Eligible Sex

ALL

Accepts Healthy Volunteers

No