ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610001003066

Ethics application status

Approved

Date submitted

23/08/2010

Date registered

17/11/2010

Date last updated

22/02/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Heated Humidified High Flow Nasal Cannula for Weaning from Nasal Continuous Positive Airway Pressure Trial in Preterm Infants (The HiFloW Trial)

Scientific title

The HiFloW Trial: A randomised controlled trial to evaluate the effectiveness of heated, humidified high flow nasal cannula (HHHFNC) in the withdrawal of nasal continuous positive airway pressure (nCPAP) in preterm infants

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

HiFloW

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic lung disease

Breathing support

Premature infant care

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

2x2 factorial design:
Group 1:Abrupt weaning from nCPAP to HHHFNC - infant is taken OFF nCPAP and put onto HHHFNC with initial flow rate titrated to deliver pressure initially produced on nCPAP, then gradually decreasing flow rate at increments of 1litre per min at the discretion of medical team. Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial.

Group 2: Abrupt weaning from nCPAP without HHHFNC - infant is taken OFF nCPAP and put into crib air/oxygen (<25%) or low flow nasal cannula oxygen if required (<1L/min). Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial.

Group 3: Gradual weaning from nCPAP to HHHFNC – infant alternates between time ON and OFF nCPAP. HHHFNC is given during OFF periods with flow rate titrated to deliver pressure initially produced on nCPAP, gradually increasing HHHFNC time by 1h increments and/or according to infant stability until nCPAP can be stopped completely.

Group 4: Gradual weaning from nCPAP without HHHFNC – infant alternates between time ON and OFF nCPAP by alternating between time on and off CPAP as the infant tolerates, gradually increasing time OFF until nCPAP can be stopped completely.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Each of the four groups will be compared in a 2x2 factorial design

Control group

Active

Outcomes

Primary outcome [1]

Chronic lung disease, defined as requiring oxygen or respiratory support at 36 weeks Postmenstrual Age

Timepoint [1]

36 weeks postmenstrual age

Primary outcome [2]

Length of Hospital Stay (days), defined as time of randomisation to time of hospital discharge. This will be obtained via data linkage to patient medical records.

Timepoint [2]

Discharge from hospital

Secondary outcome [1]

Respiratory morbidity, from data linkage to patient medical records

Timepoint [1]

Asssessed continuously from randomisation until discharge from the Neonatal Intensive Care Unit (NICU)

Secondary outcome [2]

Infant feeding and growth, from reviewing nursing bedside charts and medical records

Timepoint [2]

36 weeks PMA

Secondary outcome [3]

Infant morbidity including necrotising enterocolitis, patent ductus arteriosus, retinopathy of prematurity and late onset sepsis. This will be obtained by reviewing medical records.

Timepoint [3]

Asssessed continuously from randomisation until discharge from NICU

Secondary outcome [4]

Mother-infant interaction, based on nursing record of the duration of mother-infant cuddling from randomisation to discharge from NICU

Timepoint [4]

34 weeks PMA

Secondary outcome [5]

Nursing workload / intensity measured using a modified nursing workload intensity survey

Timepoint [5]

Nursing staff will fill survey at the end of each shift

Eligibility

Key inclusion criteria

All babies born less than 30 completed weeks gestational age, AND
1. Clinically stable on less than or equal to 5cm H2O nasal continuous positive airway pressure (nCPAP) with mouth closed OR
2. Clinically stable on nCPAP (any level) but tolerating 6 hours with mouth open, OR
3. Clinically stable on nCPAP (any level) and tolerating 6 hours OFF nCPAP

Minimum age

24 Weeks

Maximum age

30 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Infection defined as positive blood or cerebrospinal fluid culture within the previous 48 hours
Major congenital or chromosomal abnormalities
Severe neurologic insults or neuromuscular disease

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Infants will be enrolled after informed parental consent is obtained and eligibility confirmed by completing an enrolment sheet. Once the infant meets a set of stability criteria, he/she will be randomised into one of four arms via use of sequentially numbered opaque sealed envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The order of randomisation will be randomly allocated by use of a random number generator.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Factorial

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2010

Actual

1/10/2010

Date of last participant enrolment

Anticipated

Actual

30/06/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Prince Alfred (RPA) Newborn Care Research Fund

Address [1]

RPA Newborn Care
RPA Hospital
Missenden Rd
Camperdown, NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

RPA Hospital

Address

Missenden Rd
Camperdown, NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Review Committee (Royal Prince Alfred Hospital Zone) of the Sydney South West Area Health Service

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/10/2010

Ethics approval number [1]

Summary

Brief summary

Preterm babies with breathing troubles are routinely supported by the use of continuous positive airway pressure (CPAP) via nasal prongs that require taping to the infant’s face and a bonnet to maintain an adequate seal and to keep the prongs in position. This can restrict care, parent-infant cuddles and breast feeding. The prongs also occlude the nose and sometimes cause damage to the nasal septum. Weaning an infant from CPAP may take weeks or months. This is a randomised controlled trial of 2 methods of weaning CPAP support (abrupt or gradual), combined with the use of Heated Humidified High Flow Nasal Cannula (HHFNC) devices or not, making four arms / groups. The purpose of the study is to determine which method of weaning from CPAP is most effective at reducing the length of hospital stay, facilitating infant suck feeding and parent-infant interaction and reducing the intensity of nursing care.

Trial website

Trial related presentations / publications

Tang J, Reid S, Lutz T, Malcolm G, Oliver S, Osborn DA. Randomised controlled trial of weaning strategies for preterm infants on nasal continuous positive airway pressure. BMC pediatrics. 2015;15:147.

Public notes

Contacts

Principal investigator

Name

A/Prof David Osborn

Address

RPA Newborn Care, Royal Prince Alfred Hospital, Camperdown, NSW, Australia 2050

Country

Australia

Phone

61295158363

Fax

david.osborn@sydney.edu.au

Contact person for public queries

Name

David Osborn

Address

RPA Newborn Care
RPA Hospital
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

61295158363

Fax

david.osborn@email.cs.nsw.gov.au

Contact person for scientific queries

Name

David Osborn

Address

RPA Newborn Care
RPA Hospital
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

61295158363

Fax

david.osborn@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Randomised controlled trial of weaning strategies for preterm infants on nasal continuous positive airway pressure	2015	https://doi.org/10.1186/s12887-015-0462-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically