Condition category
Pregnancy and Childbirth
Date applied
29/01/2013
Date assigned
14/03/2013
Last edited
14/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Respiratory Distress Syndrome (RDS) is a common condition in preterm infants. NCPAP (Nasal Continuous Positive Airway Pressure) is a method of ventilatory support used for these infants. It provides a continuous flow and pressure of air/ oxygen through the airways into the air sacs to prevent them collapsing during expiration and reducing the work of breathing. However it is a cumbersome mask, and it can disrupt the facilitation of breast or bottle feeding when they would otherwise be ready for it.
High Flow Nasal Prong (HFNP) therapy provides a high flow of air/ oxygen through the airways and into the air sacs. This is done through smaller nasal prongs, which cause less obstruction.
Our objective is to show that when infants are ready to feed, they are more likely to feed successfully if they have the small nasal prongs as opposed to a larger mask. We aim to show that using the high flow nasal prong therapy will help them to feed sooner and to be feeding fully on breast/bottle 1 week earlier than those on NCPAP.

Who can participate?
1. Very Low Birth Weight Infants (1500g or less)
2. Born at less than 30 weeks gestation (24+0 to 29+6)
3. Neonates requiring respiratory support in the form of NCPAP at 32 weeks corrected gestational age with an oxygen requirements of less than 30%
4. Infants requiring positive end expiratory pressure (PEEP)<5 cm H2O and breathing in room air will first be offered a trial off NCPAP with no respiratory support, but if this fails they will then be eligible for randomization
5. Full enteral feeding (tube feeding)

What does the study involve?
Once eligible for the study, at 32 weeks corrected gestational age, the infant will be randomly allocated to one of two groups A or B, using a sealed envelope.
Group A will continue on NCPAP and Group B will be started on High Flow nasal prongs at 7L/min.
Both groups will receive the same 4 hourly observation monitoring.
We have estimated that we will need to recruit 22 babies in each group (total 44 infants).
We will follow them until they reach full bottle/breast feeds.

What are the possible risks and benefits from participating?
There are no specific risks or benefits from participating.
Side effects of High flow nasal prong therapy may be clinical deterioration of the infant which will be assessed by the senior doctor on call and if needed, the infant will be resumed on NCPAP.
A possible benefit of the HFNP therapy would reaching full bottle/breast feeds earlier.

Where is the study run from?
The neonatal unit in the Coombe Women and Infant’s University Hospital, Dublin 8, Ireland is running this study.

When is the study starting and how long is it expected to run for?
The study is starting in February 2013 and is expected to run for 12 to 18 months.

Who is funding the study?
Coombe Women and Infants University Hospital, Ireland

Who is the Main contact?
Dr. Jan Miletin
jmiletin@coombe.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan Miletin

ORCID ID

Contact details

Coombe Women and Infants University Hospital
Dolphin's Barn
Dublin
D 8
Ireland
jmiletin@coombe.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

High Flow Nasal Prongs (HFNP) therapy versus Nasal Continuous Positive Airway Pressure (NCPAP) in establishing full oral feeds in Very Low Birth Weight (VLBW) infants - randomized controlled trial

Acronym

HiFlow

Study hypothesis

We hypothesize that infants on HFNP therapy will be established on full feeds 1 week earlier than infants on NCPAP.

Null hypothesis: is that there is no difference or less than 1 week difference between the two groups.

Ethics approval

Research Ethics Committee, Coombe Women and Infants University Hospital, Dublin, Ireland approved on the 27th of November 2012, ref: 18 - 2012

Study design

Randomized controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Establishment of full oral bottle / breast feeding in preterm infants

Intervention

Intervention Group: Use of High Flow Nasal Prongs therapy starting at 32 weeks of corrected gestational age

Control Group: Use of Nasal Continuous Positive Airway Pressure at 32 weeks of gestation (current practice)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The establishment of full oral feeding - days from 32 weeks corrected gestational age

Secondary outcome measures

Duration of respiratory support - days from 32 weeks corrected gestational age

Overall trial start date

01/02/2013

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Very Low Birth Weight Infants (1500g or less)
2. Born at less than 30 weeks gestation (24+0 to 29+6)
3. Neonates requiring respiratory support in the form of NCPAP at 32 weeks corrected gestational age with an oxygen requirements of less than 30%
4. Infants requiring positive end expiratory pressure (PEEP)<5 cm H2O and breathing in room air will first be offered a trial off NCPAP with no respiratory support, but if this fails they will then be eligible for randomization
5. Full enteral feeding (by nasogastric or orogastric tube)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

44

Participant exclusion criteria

Significant congenital / respiratory / cardiac / airway abnormality at the time of randomization

Recruitment start date

01/02/2013

Recruitment end date

01/07/2014

Locations

Countries of recruitment

Ireland

Trial participating centre

Coombe Women and Infants University Hospital
Dublin
D 8
Ireland

Sponsor information

Organisation

Coombe Women and Infants University Hospital (Ireland)

Sponsor details

Dolphin's Barn
Dublin
D 8
Ireland
+353 (0)1 408 5276
jmiletin@coombe.ie

Sponsor type

Hospital/treatment centre

Website

http://www.coombe.ie/

Funders

Funder type

Hospital/treatment centre

Funder name

Coombe Women and Infants University Hospital (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes