Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000694213
Ethics application status
Approved
Date submitted
8/08/2009
Date registered
12/08/2009
Date last updated
20/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Giving humidified gases to preterm infants from birth
Scientific title
Effect of humidified and non humidified T piece resuscitation on admission temperatures in preterm infants <32 weeks: a randomised controlled trial
Secondary ID [1] 252523 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature infants 243485 0
Condition category
Condition code
Reproductive Health and Childbirth 239785 239785 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidified air or oxygen with positive end expiratory pressure (PEEP) is given from birth via a T piece resuscitation device. The baby is transported from delivery to neonatal unit with humidification and PEEP.
Intervention code [1] 237103 0
Treatment: Devices
Comparator / control treatment
Use of non humidified air or oxygen with positive end expiratory pressure given from birth using a T piece with pressure monitor attached to a face mask. The PEEP is maintained from delivery to neonatal unit during transport.
Control group
Active

Outcomes
Primary outcome [1] 240553 0
Core temperature(axillary) is measured using an electronic temperature probe (Welch Allen diagnostics)
Timepoint [1] 240553 0
Admission to neonatal unit
Secondary outcome [1] 257137 0
Oxygen saturation (SpO2) is measured from birth using a Masimo oximeter attached to the right hand.
Timepoint [1] 257137 0
During first hour of life
Secondary outcome [2] 257138 0
Oxygen requirement. This is assessed by reading baby's saturations and titrating the amount (%) of oxygen administered via an air/oxygen blender
Timepoint [2] 257138 0
During first hour of life

Eligibility
Key inclusion criteria
Less than 32 weeks gestation
Require respiratory support at birth
Minimum age
23 Weeks
Maximum age
31 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No respiratory distress or congenital malformation or congenital infection. Maternal temperature 38 degrees celsius or above.

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)
Allocation concealment via opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2010
Actual
30/03/2011
Date of last participant enrolment
Anticipated
Actual
10/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1940 0
New Zealand
State/province [1] 1940 0
Auckland
Country [2] 1941 0
Netherlands
State/province [2] 1941 0
Leiden

Funding & Sponsors
Funding source category [1] 237474 0
Commercial sector/Industry
Name [1] 237474 0
Fisher & Paykel Health Care
Country [1] 237474 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Meyer
Address
Neonatal Unit
Middlemore Hospital
P O Box 98743
Manukau 2241
Auckland
Country
New Zealand
Secondary sponsor category [1] 236960 0
None
Name [1] 236960 0
Address [1] 236960 0
Country [1] 236960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239599 0
Ethics committee address [1] 239599 0
Ethics committee country [1] 239599 0
Date submitted for ethics approval [1] 239599 0
12/08/2009
Approval date [1] 239599 0
15/12/2009
Ethics approval number [1] 239599 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30028 0
Dr Michael Peter Meyer
Address 30028 0
Neonatal Unit Middlemore Hospital P O Box 98743 Manuka 2241 Auckland
Country 30028 0
New Zealand
Phone 30028 0
64 9 2760000
Fax 30028 0
64 9 2760091
Email 30028 0
[email protected]
Contact person for public queries
Name 13275 0
Dr Michael Meyer
Address 13275 0
Neonatal Unit
Middlemore Hospital
P O Box 98743
Manuka 2241
Auckland
Country 13275 0
New Zealand
Phone 13275 0
0064 9 2760000
Fax 13275 0
Email 13275 0
[email protected]
Contact person for scientific queries
Name 4203 0
Dr Michael Meyer
Address 4203 0
Neonatal Unit
Middlemore Hospital
P O Box 98743
Manukau 2241
Auckland
Country 4203 0
New Zealand
Phone 4203 0
0064 9 2760000
Fax 4203 0
Email 4203 0
[email protected]

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
No additional documents have been identified.