The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants
The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
May 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedApril 28, 2022
April 1, 2022
1.5 years
November 19, 2018
April 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygenation instability
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)
Study Arms (2)
Bolus feeding
EXPERIMENTALcontinuous gavage feeding
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Premature Infants (GA\<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding\>100 ml/kg/day
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatologist
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 20, 2018
Study Start
May 29, 2019
Primary Completion
December 13, 2020
Study Completion
March 1, 2022
Last Updated
April 28, 2022
Record last verified: 2022-04