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

Phase 4

Completed

• Conditions: Infant, Very Low Birth Weight; Infant Malnutrition; Feeding Disorder of Infancy or Early Childhood; Splanchnic Oximetry; Splanchnic Oxygenation
• Interventions: Other: different nutrional regimen; Other: comparison of different feeding regimens

• Registration Number: NCT01341236
• Lead Sponsor: San Gerardo Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Study Start: 2011-09
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-21
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
continuous nutrition	different nutrional regimen	-
bolus nutrition	comparison of different feeding regimens	-

Primary Outcome Measures

Name	Time	Method
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).	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 Outcome Measures

Name	Time	Method
To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;	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) ;
• To compare growth and nutritional status of the 2 groups by randomized arm.	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
• 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.	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.
• To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance	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

Trial Locations

Locations (1)

NICU San Gerardo Hospital; 🇮🇹 Monza, MonzaBrianza, Italy