Evaluation of Splanchnic Oximetry,Doppler Flow Velocimetry in the Superior Mesenteric Artery and Feeding Tolerance in VERY LOW BIRTH WEIGHT IUGR and NON-IUGR Infants Receiving Bolus Versus Continuous Enteral Nutrition

San Gerardo Hospital1 site in 1 country41 target enrollmentSeptember 2011

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

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Infant, Very Low Birth Weight
Sponsor: San Gerardo Hospital
Enrollment: 41
Locations: 1
Primary Endpoint: changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

March 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

San Gerardo Hospital

Responsible Party

Principal Investigator

Valentina Bozzetti

Dr.

San Gerardo Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 3 hours

Evaluation of oximetry with splanchnic NIRS (difference of CSOR values and of rSO2s values) and perfusion with doppler of superior mesenteric artery (differences of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) before, during ad after feeding.

Secondary Outcomes

To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;(2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die)
• To compare growth and nutritional status of the 2 groups by randomized arm.(2 months; it's an average;it depends on the time necessary to achieve the full enteral feeding and the 36th weeks of postconceptional age)
• 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 NIRS.(2 weeks)
• To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance(1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding)