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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748472
Enrollment
24
Registered
2018-11-20
Start date
2019-05-29
Completion date
2022-03-01
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infant, Respiratory Disease

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.

Interventions

PROCEDUREContinuous 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.

PROCEDUREBolus 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.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenation instability9 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026