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

Infant, Very Low Birth Weight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01341236
• Other study ID #: Feeding VLBW
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2011
• Last updated: March 21, 2013
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: San Gerardo Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Birth Weight
• Feeding Disorder of Infancy or Early Childhood
• Infant Malnutrition
• Infant, Very Low Birth Weight
• Malnutrition
• Splanchnic Oximetry
• Splanchnic Oxygenation

Intervention

Other:
• different nutrional regimen
compare bolus versus intermittent nutrition
• comparison of different feeding regimens
compare intermittent versus bolus nutrition

Locations

Country	Name	City	State
Italy	NICU San Gerardo Hospital	Monza	MonzaBrianza

Sponsors (1)

Lead Sponsor	Collaborator
San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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) ;	2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die	No
Secondary	• 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	No
Secondary	• 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	No
Secondary	• 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	No