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
Primary Purpose
Infant, Very Low Birth Weight, Infant Malnutrition, Feeding Disorder of Infancy or Early Childhood
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
different nutrional regimen
comparison of different feeding regimens
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Very Low Birth Weight focused on measuring VLBW, IUGR, NIRS, enteral nutrition, superior mesenteric artery doppler
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
Sites / Locations
- NICU San Gerardo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
continuous nutrition
bolus nutrition
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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) ;
• 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
• 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.
• 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01341236
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Gerardo Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous nutrition
Arm Type
Active Comparator
Arm Title
bolus nutrition
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
different nutrional regimen
Intervention Description
compare bolus versus intermittent nutrition
Intervention Type
Other
Intervention Name(s)
comparison of different feeding regimens
Intervention Description
compare intermittent versus bolus nutrition
Primary Outcome Measure Information:
Title
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
Description
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.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
Description
• 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) ;
Time Frame
2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die
Title
• To compare growth and nutritional status of the 2 groups by randomized arm.
Description
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
Time Frame
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
Title
• 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.
Description
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.
Time Frame
2 weeks
Title
• To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance
Description
Time necessary to achieve full enteral feeding will be recorded
Time Frame
1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo E Tagliabue, MD
Organizational Affiliation
San Gerardo Hospital
Official's Role
Study Director
Facility Information:
Facility Name
NICU San Gerardo Hospital
City
Monza
State/Province
MonzaBrianza
ZIP/Postal Code
20052
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
27339251
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.
Results Reference
derived
PubMed Identifier
22828032
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.
Results Reference
derived
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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
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