Infant, Very Low Birth Weight Clinical Trial
Official title:
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
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
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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