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

Not Applicable

Completed

• Conditions: Respiratory Disease; Premature Infant
• Interventions: Procedure: Bolus feeding; Procedure: Continuous gavage feeding

• Registration Number: NCT03748472
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2019-05-29
• Primary Completion: 2020-12-13
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bolus feeding	Bolus feeding	-
continuous gavage feeding	Continuous gavage feeding	-

Primary Outcome Measures

Name	Time	Method
Oxygenation instability	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

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel