The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants

April 27, 2022 updated by: Liron Borenstein MD, Rambam Health Care Campus

The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants

SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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
      • Haifa, Israel
        • Rambam Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day

Exclusion Criteria:

Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease.

Instability because of:

Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bolus feeding
Procedure: Bolus feeding
Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.
Experimental: continuous gavage feeding
Procedure: Continuous gavage feeding
Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation instability
Time Frame: 9 hours (3 feeds)
SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
9 hours (3 feeds)

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

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 (Actual)

May 29, 2019

Primary Completion (Actual)

December 13, 2020

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Feeding length and oxygenation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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