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

NCT01341236 | Completed Phase 4

• 1 other identifier: Feeding VLBW
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

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).

  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

Secondary Outcomes (4)

• 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 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

• • 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

• • 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

Study Arms (2)

continuous nutrition

ACTIVE COMPARATOR

Other: different nutrional regimen

bolus nutrition

ACTIVE COMPARATOR

Other: comparison of different feeding regimens

Interventions

different nutrional regimen OTHER

compare bolus versus intermittent nutrition

continuous nutrition

comparison of different feeding regimens OTHER

compare intermittent versus bolus nutrition

bolus nutrition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight at birth ranging: 700 - 1501 grams;
• Gestational age up to 25 weeks and 6 days;
• Written informed consent from parents or guardians.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Gerardo Hospital: lead

Study Sites (1)

NICU San Gerardo Hospital

Monza, MonzaBrianza, 20052, Italy

Location

Related Publications (2)

• 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.

  PMID: 27339251 DERIVED

• 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.

  PMID: 22828032 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Paolo E Tagliabue, MD

  San Gerardo Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 25, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

IT (1)