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NCT03852641 Clinical Trial

Feeding Premature Infants During Non-invasive Respiratory Support

Premature Infant Clinical Trial

Official title:
Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03852641
Other study ID # Feeding on NIPPV
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date June 2022

Study information
Verified date February 2019
Source Rambam Health Care Campus
Contact Liron Borenstein-Levin, MD
Phone 04-7774125
Email liron.boren@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Length of feeding
Feeds will be given via nasogastric tube over 15-30 min versus 2 hr

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 as documented by oxygen saturation histograms before dischatge home at an average of 40 weeks gestation
Primary 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 Respiratory-length of respiratory support before dischatge home at an average of 40 weeks gestation
Secondary Incidence of Necrotising enterocolitis (NEC) as defined by the medical team before dischatge home at an average of 40 weeks gestation
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