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

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ClinicalTrials.gov Identifier: NCT03748472
Recruitment Status : Unknown
Verified November 2018 by Liron Borenstein MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
Liron Borenstein MD, Rambam Health Care Campus

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Premature Infant Respiratory Disease Procedure: Continuous gavage feeding Procedure: Bolus feeding Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Liron Borenstein MD, Neonatologist, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03748472    
Other Study ID Numbers: Feeding length and oxygenation
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Premature Birth
 Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications