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Trial registered on ANZCTR


Registration number
ACTRN12606000155594
Ethics application status
Approved
Date submitted
20/04/2006
Date registered
3/05/2006
Date last updated
30/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuous positive airway pressure (CPAP) weaning trial
Scientific title
A continuous positive airway pressure (CPAP) weaning trial to determine the most efficient method in weaning babies less than 30 weeks gestational age "OFF" CPAP.
Secondary ID [1] 252850 0
CPAP weaning trial follow up phase
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Babies who are on constant continuous positive airway pressure (CPAP) support need to have the CPAP weaned in order to allow the babies to breathe without support. 1129 0
Condition category
Condition code
Reproductive Health and Childbirth 1207 1207 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This trial will look at 3 methods of weaning CPAP.
Method 1. When the baby has reached the stability criteria they will be taken OFF CPAP.
Method 2. When the baby has reached the stability criteria they will be gradually taken OFF CPAP from 30 minutes to completely OFF .
Method 3. When the baby has reached the stability criteria they will be gradually taken OFF CPAP from 30 minutes to completely OFF as in method 2, but when the baby is having time OFF CPAP they will have supplemental air or oxygen via a nasal cannula at 0.5 L/min
Intervention code [1] 990 0
None
Comparator / control treatment
No control groups, 3 treament groups.
Control group
Active

Outcomes
Primary outcome [1] 1636 0
Reduction in time of respiratory support. For methods 1 and 2 this will be 24 hours "OFF" CPAP and for those in method 3, this will be 24 hours "OFF" nasal cannula. So the time on CPAP will be from the time commenced CPAP to "OFF" support.
Timepoint [1] 1636 0
5 days after OFF CPAP.
Secondary outcome [1] 2933 0
Reduction in Chronic Lung Disease (CLD) rate defined as requiring oxygen at 36 weeks post conceptional age
Timepoint [1] 2933 0
36 Weeks post conceptional age.
Secondary outcome [2] 2934 0
Reduction in admission time
Timepoint [2] 2934 0
At discharge to home.

Eligibility
Key inclusion criteria
1.All babies <30 weeks gestational age 2.On CPAP for >24 hours 3.Babies either extubated to CPAP or as a primary treatment for respiratory distress Criteria for commencing weaning: Babies must have all of the following for the past 12 hours:- 1.CPAP <6 cm H2O 2.Oxygen requirement less than 26% and not increasing 3.RR less than 60 4.No significant chest recession 5.Less than 3 episodes of mild self reverting apnoeas and/or bradycardias and/or desaturations in 1 hour for the previous 6 hours 6.Average saturation above 87% most of the time and/or transcutaneous (TcPO2)/arterial PaO2 >50 mm Hg. 7.Tolerates nose rests well during nursing cares 8.Not treated for patent ductus arteriosus (PDA) or sepsis Criteria for failed trial “OFF” at least 2 of the following:- 1.Increase work of breathing (Intercostal recession and accessory muscles contributing for respiration) with RR >75 for >1 hour 2.Increased apnoeas and/or bradycardias and/or desaturations >2 in previous 1 hour 3.Major apnoea or bradycardia requiring more sustained stimulation/ resuscitation 4.Increased O2 requirement >25% with average saturation <85% and/or TcPO2/PaO2 <45mmHg 5.pH of <7.2 6.PaCO2 of > 65 mmHg. The babies will be put back on CPAP if failed trial “OFF” CPAP. If a baby has a major apnoea and/or bradycardia requiring resuscitation they may require intubation and ventilation.
Minimum age
Not stated
Maximum age
30 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. If congenital respiratory abnormality including central and anatomical.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1320 0
Hospital
Name [1] 1320 0
The Canberra Hospital
Address [1] 1320 0
ACT, 2606
Country [1] 1320 0
Australia
Primary sponsor type
Individual
Name
Dr David Todd
Address
Neonatal Unit
The Canberra hospital
Woden
ACT
2606
Country
Australia
Secondary sponsor category [1] 1165 0
None
Name [1] 1165 0
Nil
Address [1] 1165 0
Country [1] 1165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2646 0
Westmead Hospital, Sydney West Area Health Service The Canberra Hospital, Woden ACT 2606
Royal Brisbane and Womens' Hospital
Ethics committee address [1] 2646 0
Ethics committee country [1] 2646 0
Australia
Date submitted for ethics approval [1] 2646 0
Approval date [1] 2646 0
Ethics approval number [1] 2646 0
2005/8/4.27(2087)

Summary
Brief summary
Many small babies <30 weeks gestational age have a very immature respiratory system and require respiratory support for a limited period of time until they mature and can breath by themselves. Continuous positive airway pressure (CPAP) is one such method by which support can be given to these immature babies to allow them to breath without being put on a ventilator or breathing machine. When these babies have matured a little the CPAP is weaned in order to allow the babies to breath without support. This trial will look at 3 methods of weaning CPAP to see which method is most efficient in allowing the babies to breath on their own. The trial has started at Westmead Hospital and we hope to include other Hospitals to increase our numbers in the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35906 0
Address 35906 0
Country 35906 0
Phone 35906 0
Fax 35906 0
Email 35906 0
Contact person for public queries
Name 10179 0
Dr David Todd
Address 10179 0
Newborn Intensive Care Unit (NICU)
The Canberra Hospital
PO Box 11
Woden ACT 2606
Country 10179 0
Australia
Phone 10179 0
+61 2 62444056
Fax 10179 0
+61 2 62443112
Email 10179 0
david.todd@act.gov.au
Contact person for scientific queries
Name 1107 0
Mrs Margaret Broom
Address 1107 0
Newborn Intensive Care Unit (NICU) The Canberra Hospital PO Box 11 Woden ACT 2606
Country 1107 0
Australia
Phone 1107 0
+61 2 62444056
Fax 1107 0
+61 2 62443112
Email 1107 0
Margaret.Broom@act.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary