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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valentina Bozzetti, San Gerardo Hospital
ClinicalTrials.gov Identifier:
NCT01341236
First received: April 12, 2011
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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

Condition Intervention Phase
Infant, Very Low Birth Weight
Infant Malnutrition
Feeding Disorder of Infancy or Early Childhood
Splanchnic Oximetry
Splanchnic Oxygenation
Other: different nutrional regimen
Other: comparison of different feeding regimens
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by San Gerardo Hospital:

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). [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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; [ Time Frame: 2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die ] [ Designated as safety issue: No ]
    • 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. [ 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 Frame: 1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding ] [ Designated as safety issue: No ]
    Time necessary to achieve full enteral feeding will be recorded


Enrollment: 41
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continuous nutrition Other: different nutrional regimen
compare bolus versus intermittent nutrition
Active Comparator: bolus nutrition Other: comparison of different feeding regimens
compare intermittent versus bolus nutrition

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341236

Locations
Italy
NICU San Gerardo Hospital
Monza, MonzaBrianza, Italy, 20052
Sponsors and Collaborators
San Gerardo Hospital
Investigators
Study Director: Paolo E Tagliabue, MD San Gerardo Hospital
  More Information

No publications provided by San Gerardo Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valentina Bozzetti, Dr., San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01341236     History of Changes
Other Study ID Numbers: Feeding VLBW
Study First Received: April 12, 2011
Last Updated: March 21, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by San Gerardo Hospital:
VLBW
IUGR
NIRS
enteral nutrition
superior mesenteric artery doppler

Additional relevant MeSH terms:
Birth Weight
Malnutrition
Nutrition Disorders
Infant Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014