Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000093785
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
24/01/2013
Date last updated
26/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of humidified and unconditioned gases in the delivery room for stabilising preterm infants less than 30 weeks gestation at birth
Scientific title
A randomised controlled trial comparing the effect on admission temperature of humidified versus unconditioned gases during the stabilisation of preterm infants less than 30 weeks gestation at birth
Secondary ID [1] 281742 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The HUMID Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 288082 0
Condition category
Condition code
Reproductive Health and Childbirth 288424 288424 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants under 30 weeks gestation who require respiratory support at birth will receive positive pressure delivered by gases (oxygen and air) that are heated and humidified using a heated humidifier unit. Infants requiring ongoing respiratory support will continue to receive heated and humidified gases during transport to the neonatal intensive and special care unit (NISC).
The intervention will be given for the duration of the stabilisation in the delivery room and transport from the delivery room to the NISC. This will differ on a case by case basis and be directed by the attending clinican.
Intervention code [1] 286374 0
Treatment: Other
Comparator / control treatment
Infants under 30 weeks gestation who require respiratory support at birth will receive positive pressure delivered by unconditioned gases (oxygen and air) which is the current standard care. Infants requiring ongoing respiratory support will continue to receive unconditioned gases (oxygen and air) during transport to the neonatal intensive and special care unit (NISC).
The standard care treatment will be given for the duration of the stabilisation in the delivery room and transport from the delivery room to the NISC. This will differ on a case by case basis and be directed by the attending clinican.
Control group
Active

Outcomes
Primary outcome [1] 288591 0
Rectal temperature measured with a Nexcare digital thermometer on admission to the neonatal intensive and special care unit.
Timepoint [1] 288591 0
On admission to the neonatal intensive and special care unit
Secondary outcome [1] 300548 0
Intubation in the first 24 hours.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [1] 300548 0
24 hours of age
Secondary outcome [2] 300549 0
Requirement for surfactant replacement.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [2] 300549 0
72 hours
Secondary outcome [3] 300551 0
Highest inspired oxygen requirement within the first 24 hours following admission to the neonatal intensive and special care unit.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [3] 300551 0
24 hours of age
Secondary outcome [4] 300612 0
Worst blood gas pH in the first 24 hours.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [4] 300612 0
24 hours of age
Secondary outcome [5] 300613 0
Incidence of air leaks diagnosed clinically or on radiological examination. This outcome will be assessed from patient data recorded in the medical records and nursing charts and reports of radiological examinations.
Timepoint [5] 300613 0
Incidence monitored until discharge from hospital
Secondary outcome [6] 300614 0
Incidence of bronchopulmonary dysplasia defined as requirement for respiratory support and/or oxygen at 36 weeks corrected gestation.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [6] 300614 0
36 weeks corrected gestation
Secondary outcome [7] 300615 0
Total duration in days of respiratory support including ventilation via an endotrachael tube, nasal continuous positive airway pressure, high flow nasal cannulae and low flow oxygen.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [7] 300615 0
Until discharge from hospital
Secondary outcome [8] 300616 0
Length of hospital stay (combined duration of stay in level 1, 2 and 3 units)
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [8] 300616 0
Until discharge from hospital
Secondary outcome [9] 300617 0
All cause mortality before discharge from hospital.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [9] 300617 0
Until discharge from hospital
Secondary outcome [10] 300618 0
Associated morbidities: a) hypotension requiring inotrope support; b) patent ductus arteriosus requiring treatment;
c) Ultrasound evidence of brain injury: Grade 3 or 4 intraventricular haemorrhage and Periventricular Leucomalacia.
This outcome will be assessed from patient data recorded in the medical records and nursing charts.
Timepoint [10] 300618 0
Until discharge from hospital

Eligibility
Key inclusion criteria
Preterm infants less than 30 weeks gestation born in the participating centres
Minimum age
23 Weeks
Maximum age
29 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Maternal pyrexia greater than 38.0 degrees celsius within 4 hours of birth. Consent not obtained Imperforate anus (this will be a post randomisation exclusion) No requirement for respiratory support (this will be a post randomisation exclusion)

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)
Sealed opaque envelopes
Sequentially numbered, sealed, opaque envelopes containing the allocaton will be opened by the researcher or clinican just before birth.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by gestational age (23-25 and 26-29 weeks) and site.
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
Recruiting
Date of first participant enrolment
Anticipated
28/01/2013
Actual
19/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 402 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 407 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 6171 0
3052 - Parkville
Recruitment postcode(s) [2] 6174 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 286531 0
Government body
Name [1] 286531 0
National Health and Medical Research Council Program Grant
Country [1] 286531 0
Australia
Funding source category [2] 286534 0
Hospital
Name [2] 286534 0
The Royal Women's Hospital
Country [2] 286534 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Davis
Address
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 285319 0
None
Name [1] 285319 0
Address [1] 285319 0
Country [1] 285319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288604 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 288604 0
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052
Ethics committee country [1] 288604 0
Australia
Date submitted for ethics approval [1] 288604 0
12/12/2012
Approval date [1] 288604 0
Ethics approval number [1] 288604 0
12/45

Summary
Brief summary
Infants born very prematurely (under 30 weeks gestation) often require support with their breathing after birth as their lungs are stiff and they find it hard to fill them with air. In order to help infants breathe we use a flow of gas (oxygen and air) to provide pressure to help open their lungs. In this study we are comparing whether it is better to use a gas flow that has been warmed and moistened (humidified), compared to the standard method of using gas directly from the cylinder or wall (unconditioned). Humidifying gases is routine within the setting of the neonatal intensive care but is not extended to use in the delivery room setting.
The purpose of this study is to find out whether the use of humidified gases in the delivery room is better in helping premature infants stay warm immediately after birth. The primary outcome will be measurement of rectal temperature on admission to the neonatal and intensive care unit (NISC).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36890 0
Dr Lorraine McGrory
Address 36890 0
Newborn Research
Level 7
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
VIC 3052
Country 36890 0
Australia
Phone 36890 0
+61 3 83453776
Fax 36890 0
Email 36890 0
lorraine.mcgrory@thewomens.org.au
Contact person for public queries
Name 36891 0
Lorraine McGrory
Address 36891 0
Newborn Research
Level 7
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
VIC 3052
Country 36891 0
Australia
Phone 36891 0
+61 3 83453776
Fax 36891 0
Email 36891 0
lorraine.mcgrory@thewomens.org.au
Contact person for scientific queries
Name 36892 0
Lorraine McGrory
Address 36892 0
Newborn Research
Level 7
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
VIC 3052
Country 36892 0
Australia
Phone 36892 0
+61 3 83453776
Fax 36892 0
Email 36892 0
lorraine.mcgrory@thewomens.org.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
SourceTitleYear of PublicationDOI
EmbaseA Randomized Trial of Conditioned or Unconditioned Gases for Stabilizing Preterm Infants at Birth.2018https://dx.doi.org/10.1016/j.jpeds.2017.09.006
N.B. These documents automatically identified may not have been verified by the study sponsor.