Feeding Premature Infants During Non-invasive Respiratory Support

Not Applicable

• Conditions: Premature Infant; Non-invasive Respiratory Support
• Interventions: Other: Length of feeding

• Registration Number: NCT03852641
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Study First Posted: 2019-02-25
• Last Update Posted: 2019-02-25
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Infants <1500gr, on non-invasive respiratory support
• Feeding>20 ml/kg/day

Exclusion Criteria

• Major congenital malformations
• Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
• Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus gavage feeds	Length of feeding	Bolus gavage feeds over 15-30 minutes
Continuous feeds	Length of feeding	Continuous feeds over 2.0 hrs

Primary Outcome Measures

Name	Time	Method
Oxygenation instability as documented by oxygen saturation histograms	before dischatge home at an average of 40 weeks gestation
Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day	before dischatge home at an average of 40 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Incidence of Necrotising enterocolitis (NEC) as defined by the medical team	before dischatge home at an average of 40 weeks gestation
Respiratory-length of respiratory support	before dischatge home at an average of 40 weeks gestation

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel