ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

prematurity
chronic lung disease

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

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]

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]

Oxygen saturation during the bottle feed will be measured by pulse oximeter

Timepoint [1]

variable according to how long it takes the infant to complete the bottle feed or 30 minutes whichever occurs first

Primary outcome [2]

Heart rate during the study bottle feeds will be measured by pulse oximeter

Timepoint [2]

variable according to how long it takes the infant to complete the bottle feed or 30 minutes whichever occurs first

Secondary outcome [1]

Efficiency of feed measured by volume (per kilogram weight) consumed during the feed.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

The Royal Women's Hospital

Address

20 Flemington Road, Parkville, Victoria, 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital Research and Ethics Committee

Ethics committee address [1]

The Royal Women's Hospital
20 Flemington Road
Parkville, Victoria, 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2013

Approval date [1]

04/09/2013

Ethics approval number [1]

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

Dr Jennifer Dawson

Address

Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+61 3 8345 3791

Fax

jennifer.dawson@thewomens.org.au

Contact person for public queries

Name

Jennifer Dawson

Address

Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+61 3 8345 3791

Fax

jennifer.dawson@thewomens.org.au

Contact person for scientific queries

Name

Jennifer Dawson

Address

Newborn Research
The Royal Women's Hosptial
20 Flemington Road
Parkville, Victoria, 3052

Country

Australia

Phone

+61 3 8345 3791

Fax

jennifer.dawson@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

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Documents added automatically

No additional documents have been identified.

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