Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000944932
Ethics application status
Approved
Date submitted
12/08/2011
Date registered
1/09/2011
Date last updated
7/09/2023
Date data sharing statement initially provided
7/09/2023
Date results provided
7/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of position during bottle feeding on physiological stability in preterm infants
Scientific title
Effect of position during bottle feeding on physiological stability in preterm infants
Secondary ID [1] 262824 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 270547 0
Condition category
Condition code
Respiratory 270559 270559 0 0
Normal development and function of the respiratory system
Other 270705 270705 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Reproductive Health and Childbirth 270871 270871 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Side-lying position for bottle feeding two bottle feeds will be studied. One feed will be given with the side-lying position and one feed will be given with the standard cradle hold position. The order of the feeds will be randomised. Feeds will be given by the infant's parent or by a nurse accredited to give study feeds. There will be at least 12 hours between the two study feeds
Intervention code [1] 269316 0
Treatment: Other
Comparator / control treatment
One feed will be given with the side-lying position and one feed will be given with the standard cradle hold position. The order of the feeds will be randomised. Feeds will be given by the infant's parent or by a nurse accredited to give study feeds. There will be at least 12 hours between the two study feeds
Control group
Active

Outcomes
Primary outcome [1] 269301 0
Oxygen saturation measured by a pulse oximeter
Timepoint [1] 269301 0
Every 5 mins during the feed and then every 10 mins until 60 minutes after the feed
Primary outcome [2] 269302 0
Heart rate measured by a pulse oximeter.
Timepoint [2] 269302 0
Every 5 mins during the feed and then every 10 mins until 60 minutes after the feed
Primary outcome [3] 269420 0
Respiratory rate
Timepoint [3] 269420 0
This will be measured by the researcher counting the infants respirations every 5 mins during the feed and then every 10 mins until 60 minutes after the feed
Secondary outcome [1] 287594 0
Efficiency of feeding method defined as the volume of milk consumed in mls/kg by the infant.
Timepoint [1] 287594 0
30 minutes from the start of the bottle feed

Eligibility
Key inclusion criteria
Infants less than 34 weeks gestation at birth
Infants who were born less than 34weeks at birth and at the time of the first study feed are greater than 34 weeks corrected gestation.
Infants must be having at least two suck feeds per day and less than four suck feeds per day. The number of suck feeds per day can be a combination of breast or bottle feeds
Minimum age
23 Weeks
Maximum age
33 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious illness precluding bottle feeds
Craniofacial/structural abnormalities
Transfer to another hospital planned or likely during the study period
Parents unable to speak or read Englishe
Bottle feeds given with a special needs feeder
Parents do not agree to their infant receiving bottle feeds
Infants having more than four suck feeds per day

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)
numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sized block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2011
Actual
29/08/2011
Date of last participant enrolment
Anticipated
29/08/2011
Actual
29/11/2011
Date of last data collection
Anticipated
Actual
21/02/2012
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 269648 0
Self funded/Unfunded
Name [1] 269648 0
Country [1] 269648 0
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
Cnr Grattan St & Flemington Road
Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 266680 0
None
Name [1] 266680 0
Address [1] 266680 0
Country [1] 266680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269595 0
The Royal Women's Hospital Research Ethics Committee
Ethics committee address [1] 269595 0
Ethics committee country [1] 269595 0
Australia
Date submitted for ethics approval [1] 269595 0
Approval date [1] 269595 0
24/06/2011
Ethics approval number [1] 269595 0
11/17

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

Contacts
Principal investigator
Name 32931 0
Dr Jennifer Dawson
Address 32931 0
The Royal Women's Hospital
20 Flemington Road
parkville, Victoria, 3052
Country 32931 0
Australia
Phone 32931 0
+61 3 8345 3791
Fax 32931 0
Email 32931 0
[email protected]
Contact person for public queries
Name 16178 0
Dr Jennifer Dawson
Address 16178 0
Newborn Research
The Royal Women's Hospital
Cnr Grattan St & Flemington Road
Parkville, Victoria, 3052
Country 16178 0
Australia
Phone 16178 0
+61 03 8345 3791
Fax 16178 0
+61 03 8345 3789
Email 16178 0
[email protected]
Contact person for scientific queries
Name 7106 0
Dr Jennifer Dawson
Address 7106 0
Newborn Research
The Royal Women's Hospital
Cnr Grattan St & Flemington Road
Parkville, Victoria, 3052
Country 7106 0
Australia
Phone 7106 0
+61 03 8345 3791
Fax 7106 0
+61 03 8345 3789
Email 7106 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial completed before ICMJE policy change


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.