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

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748472
• Other study ID #: Feeding length and oxygenation
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2022
• Est. primary completion date: December 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)