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

April 29, 2015 updated by: Meir Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Neonatal Intensive Care Unit - Meir Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit.

Description

Inclusion Criteria:

  • Born 23+0 to 31+6 weeks gestational age.
  • 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:

  • Major congenital anomalies (severe heart or cerebral disease, chromosomal abnormalities, any malformation or disease of the gastrointestinal tract).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Bolus feeding
Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit
Continuous feeding
Preterm infants born in Meir Medical Center and being treated in the Neonatal Intensive Care Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in splanchnic regional tissue oxygenation before and after a bolus / continuous feeding.
Time Frame: 10 hours
Measurement of the regional tissue oxygenation of the intestines using NIRS (Near Infra-Red Spectroscopy) technology before and after a bolus feeding and then a continuous feeding.
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Gisela Sirota, M.D., Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 267-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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