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UnknownNCT02072109

Comparison of Regional Splanchnic Tissue Oxygenation Measured by NIRS in Preterm Babies Fed Bolus Versus Continuous Feeding

Evaluation of Regional Splanchnic Tissue Oxygenation Measured by NIRS (Near Infrared Spectroscopy) in Preterm Infants Receiving Bolus Versus Continuous Feeding

Status
Unknown
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Meir Medical Center · Academic / Other
Sex
All
Age
10 Days – 6 Months
Healthy volunteers
Not accepted

Summary

Early initiation of enteral feeding, achievement of full enteral feeding and cessation of parenteral nutrition are extremely important in the very premature infant. This way it is possible to achieve good post-natal growth and developement while minimizing the metabolic and infectious complications of parenteral feeding. There isn't much information in literature regarding the impact of enteral feeding on intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is also no consensus regarding the best regimen of delivering the enteral nutrition - bolus feeding or continuous feeding. The aim of our study is to compare the intestinal regional oxygenation before and after two feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm infants born before 32 weeks gestation. The evaluations will be performed using NIRS technology (Near Infrared Spectroscopy). The study may help to assess which feeding regimen is gentler to the immature intestines (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way to feed preterm infants.

Detailed description

Early initiation of enteral feeding, achievement of full enteral feeding and cessation of parenteral nutrition are extremely important in the very premature infant. This way it is possible to achieve good post-natal growth and developement while minimizing the metabolic and infectious complications of parenteral feeding. There isn't much information in literature regarding the impact of enteral feeding on intestinal blood flow and intestinal regional oxygenation in the preterm infant. There is also no consensus regarding the best regimen of delivering the enteral nutrition - bolus feeding or continuous feeding. The aim of our study is to compare the intestinal regional oxygenation before and after two feeding regimens - bolus feeding and continuous feeding - in clinically stable preterm infants born before 32 weeks gestation. The evaluations will be performed using NIRS technology (Near Infrared Spectroscopy). The investigators intend to assess 20 clinically stable, appropriate for gestational age preterm infants, born before 32 weeks of gestation and receiving full enteral feedings at least 1 week prior to enrollment with no signs of feeding intolerance. All 20 participants evaluated constitute the 2 study groups: 1. Group 1 = Bolus feeding - before and after one bolus feeding 2. Group 2 = Continuous feeding - before and after one continuous feeding. The study may help to assess which feeding regimen is gentler to the immature intestines (i.e. alters less the splanchnic blood flow and oxygenation) and therefore the preferred way to feed preterm infants.

Conditions

Timeline

Start date
2014-06-01
Primary completion
2016-02-01
Completion
2016-06-01
First posted
2014-02-26
Last updated
2015-04-30

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT02072109. Inclusion in this directory is not an endorsement.