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NCT Number: 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

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

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Key information

Conditions

Infant, Very Low Birth Weight Feeding Disorder of Infancy or Early Childhood Infant Malnutrition Infant Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases Splanchnic Oximetry Splanchnic Oxygenation

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NICU San Gerardo Hospital

Monza, MonzaBrianza, 20052, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

different nutrional regimen

Other

compare bolus versus intermittent nutrition

comparison of different feeding regimens

Other

compare intermittent versus bolus nutrition

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    • 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) ;

  2. • 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

    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

  3. • 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

    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.

  4. • 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

    Time necessary to achieve full enteral feeding will be recorded

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2011
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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