ISRCTN66716753 - Can High Flow Nasal Prongs therapy facilitate earlier establishment of full oral feeds in babies who are Nasal Continuous Positive Airway Pressure dependent at 32 weeks gestation?

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21 March 2013

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Can High Flow Nasal Prongs therapy facilitate earlier establishment of full oral feeds in babies who are Nasal Continuous Positive Airway Pressure dependent at 32 weeks gestation?

ISRCTN	ISRCTN66716753
DOI	10.1186/ISRCTN66716753
ClinicalTrials.gov identifier
EudraCT number
Public title	Can High Flow Nasal Prongs therapy facilitate earlier establishment of full oral feeds in babies who are Nasal Continuous Positive Airway Pressure dependent at 32 weeks gestation?
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
Serial number at source	N/A
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.
Lay 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
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
Countries of recruitment	Ireland
Disease/condition/study domain	Establishment of full oral bottle / breast feeding in preterm infants
Participants - 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)
Participants - exclusion criteria	Significant congenital / respiratory / cardiac / airway abnormality at the time of randomization
Anticipated start date	01/02/2013
Anticipated end date	01/07/2014
Status of trial	Ongoing
Patient information material	Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants	44
Interventions	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)
Primary outcome measure(s)	The establishment of full oral feeding - days from 32 weeks corrected gestational age
Secondary outcome measure(s)	Duration of respiratory support - days from 32 weeks corrected gestational age
Sources of funding	Coombe Women and Infants University Hospital (Ireland)
Trial website
Publications
Contact name	Dr Jan Miletin
Address	Coombe Women and Infants University Hospital Dolphin's Barn
City/town	Dublin
Zip/Postcode	D 8
Country	Ireland
Email	jmiletin@coombe.ie
Sponsor	Coombe Women and Infants University Hospital (Ireland)
Address	Dolphin's Barn
City/town	Dublin
Zip/Postcode	D 8
Country	Ireland
Tel	+353 (0)1 408 5276
Fax	+353 (0)1 453 6033
Email	jmiletin@coombe.ie
Sponsor website:	http://www.coombe.ie/
Date applied	29/01/2013
Last edited	14/03/2013
Date ISRCTN assigned	14/03/2013


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