Comparison of Regional Splanchnic Tissue Oxygenation Measured by NIRS in Preterm Babies Fed Bolus Versus Continuous Feeding
NCT ID: NCT02072109
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2014-06-30
2016-06-30
Brief Summary
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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
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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
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Bolus feeding
Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit
No interventions assigned to this group
Continuous feeding
Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Appropriate for gestational age.
* Clinically stable.
* Full enteral feeding at least 1 week prior to enrollment.
* Bolus feeding.
* No signs of feeding intolerance.
Exclusion Criteria
* Previous diagnosis of necrotizing enterocolitis or spontaneous intestinal perforation.
* Need for blood transfusion 1 week prior to enrollment.
* Need for vasopressor therapy 1 week prior to enrollment.
* Cutaneous disease not allowing the placement of the NIRS probe.
10 Days
6 Months
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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Gisela Sirota, M.D.
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Neonatal Intensive Care Unit - Meir Medical Center
Kfar Saba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Gisela Sirota, MD
Role: primary
Other Identifiers
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267-13
Identifier Type: -
Identifier Source: org_study_id