NCT03852641

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

4.2 years

First QC Date

February 20, 2019

Last Update Submit

February 21, 2019

Conditions

Premature InfantNon-invasive Respiratory Support

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Respiratory-length of respiratory support

    before dischatge home at an average of 40 weeks gestation

  • Incidence of Necrotising enterocolitis (NEC) as defined by the medical team

    before dischatge home at an average of 40 weeks gestation

Study Arms (2)

Bolus gavage feeds

EXPERIMENTAL

Bolus gavage feeds over 15-30 minutes

Other: Length of feeding

Continuous feeds

EXPERIMENTAL

Continuous feeds over 2.0 hrs

Other: Length of feeding

Interventions

Length of feedingOTHER

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

Bolus gavage feedsContinuous feeds

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Liron Borenstein-Levin, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Borenstein-Levin, MD

CONTACT

04-7774125liron.boren@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 25, 2019

Study Start

October 1, 2017

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)