Feeding Premature Infants During Non-invasive Respiratory Support

NCT ID: NCT03852641

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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Conditions

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Premature Infant Non-invasive Respiratory Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bolus gavage feeds

Bolus gavage feeds over 15-30 minutes

Group Type EXPERIMENTAL

Length of feeding

Intervention Type OTHER

Feeds will be given via nasogastric tube over 15-30 min versus 2 hr

Continuous feeds

Continuous feeds over 2.0 hrs

Group Type EXPERIMENTAL

Length of feeding

Intervention Type OTHER

Feeds will be given via nasogastric tube over 15-30 min versus 2 hr

Interventions

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Length of feeding

Feeds will be given via nasogastric tube over 15-30 min versus 2 hr

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Liron Borenstein MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liron Borenstein-Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Liron Borenstein-Levin, MD

Role: CONTACT

04-7774125

Facility Contacts

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Liron Borenstein-Levin, MD

Role: primary

972542243556

Other Identifiers

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Feeding on NIPPV

Identifier Type: -

Identifier Source: org_study_id

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