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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:
DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.
INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous nutrition | Active Comparator |
| |
| bolus nutrition | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| different nutrional regimen | Other | compare bolus versus intermittent nutrition |
| |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN). | 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. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants; | • To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants with NIRS (difference of CSOR values and of rSO2s values) and doppler of the superior mesenteric artery measurements (difference of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) ; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo E Tagliabue, MD | San Gerardo Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NICU San Gerardo Hospital | Monza | MonzaBrianza | 20052 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27339251 | Derived | Bozzetti V, Paterlini G, De Lorenzo P, Gazzolo D, Valsecchi MG, Tagliabue PE. Impact of Continuous vs Bolus Feeding on Splanchnic Perfusion in Very Low Birth Weight Infants: A Randomized Trial. J Pediatr. 2016 Sep;176:86-92.e2. doi: 10.1016/j.jpeds.2016.05.031. Epub 2016 Jun 20. | |
| 22828032 | Derived | Bozzetti V, Paterlini G, Meroni V, DeLorenzo P, Gazzolo D, Van Bel F, Visser GH, Valsecchi M, Tagliabue PE. 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. BMC Pediatr. 2012 Jul 24;12:106. doi: 10.1186/1471-2431-12-106. |
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| comparison of different feeding regimens |
| Other |
compare intermittent versus bolus nutrition |
|
| 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. | Measurements of body weight (grams), length and head circumference (cm) will be performed at predefined times: at birth, at the beginning of MEF, on the randomization day, at the achievement of full enteral feeding, at 28 days of life and at 36 weeks of gestational age | 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. | Comparison of the values of Doppler flow velocimetry of the superior mesenteric artery and of abdominal NIRS during feeding with those registered after birth, in the first 24 hours of life, and in the transitional period. | 2 weeks |
| • To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance | Time necessary to achieve full enteral feeding will be recorded | 1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding |
| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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