Clinical trial NCT01341236: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infant, Very Low Birth Weight
Infant Malnutrition
Feeding Disorder of Infancy or Early Childhood
Splanchnic Oximetry
Splanchnic Oxygenation
Keywords: VLBW
IUGR
NIRS
enteral nutrition
superior mesenteric artery doppler
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
timeFrame: 3 hours
Secondary outcomes:
measure: To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
timeFrame: 2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die
measure: • To compare growth and nutritional status of the 2 groups by randomized arm.
timeFrame: 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
measure: • 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.
timeFrame: 2 weeks
measure: • To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance
timeFrame: 1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding
Other outcomes:
Locations:
city: Monza
country: Italy
facility: NICU San Gerardo Hospital
state: MonzaBrianza
Study officials:
affiliation: San Gerardo Hospital
name: Paolo E Tagliabue, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.