Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000735752
Ethics application status
Approved
Date submitted
7/03/2013
Date registered
3/07/2013
Date last updated
13/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating side-lying for bottle feeding preterm infants on respiratory support
Scientific title
In preterm infants receiving respiratory support does a side-lying position compared to a standard cradle-hold position improve physiological stability
Secondary ID [1] 282087 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity
chronic lung disease 288589 0
Condition category
Condition code
Respiratory 288918 288918 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 288925 288925 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants will have a study feed in two positions, the standard cradle-hold and the side-lying position. Infants will have a maximum of 30 minutes to complete the feed. If the total volume of milk offered is not consumed it will be admiinistered via the infants gastric tube.
At least 12hours later they will have the second feed in the alternate position.
Intervention code [1] 286691 0
Other interventions
Comparator / control treatment
Infants will have a study feed in two positions, the standard cradle hold (control) and the other feed in the alternate side-lying position. Infants will have a maximum of 30 minutes to complete the feed. If the total volume of milk offered is not consumed it will be admiinistered via the infants gastric tube.
At least 12hours later they will have the second feed in the alternate position.
Control group
Active

Outcomes
Primary outcome [1] 289044 0
Oxygen saturation during the bottle feed will be measured by pulse oximeter
Timepoint [1] 289044 0
variable according to how long it takes the infant to complete the bottle feed or 30 minutes whichever occurs first
Primary outcome [2] 289045 0
Heart rate during the study bottle feeds will be measured by pulse oximeter
Timepoint [2] 289045 0
variable according to how long it takes the infant to complete the bottle feed or 30 minutes whichever occurs first
Secondary outcome [1] 301634 0
Efficiency of feed measured by volume (per kilogram weight) consumed during the feed.
Timepoint [1] 301634 0
variable according to how long it takes the infant to complete the bottle feed or 30 minutes whichever occurs first

Eligibility
Key inclusion criteria
Infants born preterm (<34weeks gestation) who are having bottle feeds whilst currently recieiving respiratory support, eg CPAP, or sub nasal oxygen administered at low or high flows
Minimum age
23 Weeks
Maximum age
33 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with craniofacial/structural abnormalities.
Infants receiving bottle feeds using a special needs bottle.
Infants who are likely to be transferred to another neonatal unit before both study feeds can be completed.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Demographic and clinical data including gestational age, birth weight, post-menstrual age, weight at time of study, oxygen concentration, and type of respiratory support will be extracted from the infant’s clinical record. The mean HR, RR, and SpO2 before, during and after feeds will be determined from the pulse oximeter downloads. Paired t tests will be used to compare continuous data, HR, RR, SpO2 and EtCO2. Proportions will be compared using the chi-squared test. Logistic regression with adjustment for repeated measures will be used to explore whether type of hold during feeding affects the probability of an infant experiencing an SpO2 < 80%. The data will be analysed using Stata (Intercooled 12.0, Statacorp Texas, USA).
Sample size: Data from our previous feeding study showed that 7/8 (87%) infants receiving respiratory support during a cradle-hold bottle feed experienced a period of SpO2 < 80% during a feed. A sample size of 46 infants with each infant receiving a feed in each position (i.e. two study feeds) would be sufficient to detect a reduction in the number of infants experiencing an SpO2 < 80% during a feed from 87% to 44% (a 50% reduction), with 90% power and a 2-tailed alpha-error of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2013
Actual
4/09/2013
Date of last participant enrolment
Anticipated
1/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 728 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 6526 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286864 0
Self funded/Unfunded
Name [1] 286864 0
Country [1] 286864 0
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Road, Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 285656 0
None
Name [1] 285656 0
Address [1] 285656 0
Country [1] 285656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288924 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 288924 0
The Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052
Ethics committee country [1] 288924 0
Australia
Date submitted for ethics approval [1] 288924 0
07/03/2013
Approval date [1] 288924 0
04/09/2013
Ethics approval number [1] 288924 0

Summary
Brief summary
Infants born prematurely often require gastric tube feeding. The transition from gastric tube feeds to sucking feeds (breast and/ or bottle) usually starts around 32-34 weeks’ post menstrual age when infants begin to demonstrate the ability to coordinate sucking, swallowing and breathing. However, during sucking feeds immature infants may experience physiological instability, including lower oxygen saturations (SpO2) and heart rates (HR), and periods of apnoea or cyanosis. However, preterm infants may have sucking feeds by bottle for a number of reasons, for example infants whose mothers are no longer expressing, or who are unable to be present for a breastfeed.
During bottle feeds infants typically feed cradled in a flexed, semi-reclining “en face” position. In contrast, during breastfeeding infants’ are generaly placed so that they lie across the mother’s abdomen in an unflexed position with the infant’s head in a straight line with their body. In a pilot study, comparing a side-lying position against a semi-upright position for bottle feeding preterm infants, Clark reported an improvement in SpO2 measurements in the side-lying position
In our previous study at RWH with 25 preterm infants we showed there was little difference in mean (SD) SpO2 during feeds between the cradle-hold and side-lying position 94(6)% versus 95(6)% respectively (p=0.55, CI -1.4, 5.4). During feeds 17/ 25 (68%) experienced a period of SpO2 <80% in the cradle-hold position compared with 14/25(56)% in the side-lying position (p=0.26, CI 0.68, 4.10). However, in post hoc analysis we saw that in 8 infants receiving
respiratory support during feeds 7/8 (87%) versus 5/8 (62%) in cradle versus side lying feeding positions experienced a SpO2 < 80% (p=0.25). There are several reports showing that there is a reduction in oxygen saturation in preterm infants with bronchopulmonary dysplasia (BPD) during bottle feeds in the cradle-hold position. Residual lung disease is probably the most
prevalent sequela of prematurity that affects feeding. There are no reports measuring the effect of alternate bottle feeding positions for infants receiving respiratory support during bottle feeding. We hypothesise that for infants who are receiving respiratory support there might be increased physiological stability during bottle-feeding in the side-lying versus the cradle-hold position.
The aim of this study is to determine the physiological stability and efficiency of bottle feeding in the side lying position (SLP) in preterm infants receiving respiratory support who are transitioning to suck feeds.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38366 0
Dr Jennifer Dawson
Address 38366 0
Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052
Country 38366 0
Australia
Phone 38366 0
+61 3 8345 3791
Fax 38366 0
Email 38366 0
[email protected]
Contact person for public queries
Name 38367 0
Dr Jennifer Dawson
Address 38367 0
Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052
Country 38367 0
Australia
Phone 38367 0
+61 3 8345 3791
Fax 38367 0
Email 38367 0
[email protected]
Contact person for scientific queries
Name 38368 0
Dr Jennifer Dawson
Address 38368 0
Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052
Country 38368 0
Australia
Phone 38368 0
+61 3 8345 3791
Fax 38368 0
Email 38368 0
[email protected]

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