Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000897369
Ethics application status
Approved
Date submitted
30/11/2015
Date registered
19/06/2017
Date last updated
19/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Suck swallow breathe coordination in term breastfed infants with and without oral anomalies.
Scientific title
Infants with ankyloglossia and feeding difficulties: the effect of frenotomy on suck-swallow breathe coordination, intra-oral vacuum, breastfeeding efficiency and duration compared to age-matched infants without ankyloglossia and feeding difficulties.
Secondary ID [1] 288039 0
Nil known
Universal Trial Number (UTN)
U1111-1177-1146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankyloglossia 296903 0
Condition category
Condition code
Surgery 297137 297137 0 0
Surgical techniques
Reproductive Health and Childbirth 303084 303084 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants with ankyloglossia will attend one study session up to 10 days prior to frenotomy and one study session 14-21 days after frenotomy for monitoring of a breastfeed.
A paediatric surgeon will perform frenotomy, a simple surgical treatment that divides the lingual frenulum. Normally general anaesthesia is not required and some medical practitioners prefer to use a topical anaesthetic; the paediatric surgeon participating in this study does not use general anaesthesia in infants < 6 months (all of our study subjects are < 6 months of age and therefore will not have general anaesthesia). The infant’s tongue is gently lifted with a sterile grooved retractor or index finger to expose the lingual frenulum. An incision is made using sterile iris scissors to divide the frenulum between the tongue and alveolar ridge. The procedure is typically completed within a few minutes. The infant is immediately returned to the mother for a breastfeed.
All study infants will be followed up by telephone to 12 months of age.
Intervention code [1] 293362 0
Treatment: Surgery
Comparator / control treatment
Infants with no ankyloglossia and no breastfeeding problems will attend one study session for monitoring of a breastfeed. They will not receive any intervention.
Control group
Active

Outcomes
Primary outcome [1] 296753 0
(Monitored breastfeed sessions include measurement of SSB coordination, intra-oral vacuum, ultrasound observation of tongue movement, respiratory inductive plethysmography, heart rate and oxygen saturation monitoring, milk intake and maternal ratings of pain during feeding and confidence in breastfeeding. )
Primary outcome 1: Intra-oral vacuum during breastfeeding
Intra-oral vacuum (relative to atmospheric, mmHg) will be measured via a small Silastic silicon tube (Supplemental Nursing System, Medela AG, Baar, Switzerland) filled with sterile water. One end is taped to the breast, positioned alongside and terminating just past the nipple tip (1-2mm). The other end is attached to a pressure transducer (SP854, Memscap, Bernin, France) via a silicone tube (650 mm x 4 mm) and a three way tap with a disposable clip-on dome (MLA844, AD Instruments, Castle Hill, NSW, Australia). The Silastic tube is very fine and soft; infants do not appear to be aware of the presence of the tube and it does not cause any discomfort to the breastfeeding mother.
Timepoint [1] 296753 0
Time point:
Control group: a single monitored breastfeed whereby intra-oral vacuum is monitored continuously throughout the duration of the feed.
Ankyloglossia group: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment.
Secondary outcome [1] 319267 0
Tongue movement during breastfeeding
Submental mid-sagittal scans of the infant’s oral cavity will be performed for the duration of the entire feed to monitor tongue movement in relation to the nipple and palate. The infants will be scanned using Aplio 80 ultrasound (Toshiba SSA-770A/80, Tokyo, Japan) with endocavity convex transducer (PVT-661VT and Parker Ultrasonic Gel (Fairfield, New Jersey, USA). Two focal zones will be employed to narrow the ultrasound beam and improve image resolution. One will be located at the level of the hard palate and the other at the nipple–tongue border.

The outputs from the ultrasound machine, pressure transducer, RIP, and pulse oximeter will be synchronised by the LactaSearch device (Medela, Barr, Switzerland) and recorded using the software package DIAdem (version 11.1, National Instruments, Texas, USA) with a custom designed program for offline data analysis.
Timepoint [1] 319267 0
Control group: a single monitored breastfeed whereby sonograpy is performed continuously throughout the duration of the feed.
Ankyloglossia group: monitored breastfeeds whereby sonography is performed continuously throughout the duration of the feed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [2] 319269 0
Secondary outcome 2: Milk transfer (mL) during breastfeeding
To determine milk intake infant test weighs will be performed for all breastfeeds. Electronic scales (BabyWeigh Scale, Medela AG, Baar, Switzerland, sensitive to 2 grams) will be used to weigh infants before and immediately after the feed. The amount of milk consumed is calculated as the difference in grams between the pre-feed and post-feed infant weights, and 1 gram is equivalent to 1 mL.
Timepoint [2] 319269 0
Control group: a test weigh of a monitored single breastfeed
Ankyloglossia group: test weighing of two monitored breastfeeds ie. pre (up to 10 days before) and post (14-21 days after) frenotomy treatment.
Secondary outcome [3] 319270 0
Breastfeeding duration
Follow up telephone interviews will be conducted to determine duration of 'any breastfeeding' (ie. partial or exclusive) with note made of duration of 'exclusive breastfeeding' (ie. duration of time during which infant was fed only breast milk).
Timepoint [3] 319270 0
Secondary outcome time point: 3 months postnatal
Secondary outcome [4] 336081 0
Swallow-breathe coordination during breastfeeding
Patterns of infant respiration and swallowing will be measured continuously using respiratory inductive plethysmography (RIP), (Respitrace QDC, SensorMedics, Yorba Linda, CA, USA) with two bands; one placed around the thorax at the level of the nipples and a second around the abdomen at the level of the umbilicus. The output will display thoracic trace, the abdomen trace and the sum of thoracic and abdomen effort. Bands will be secured using Micropore tape (if necessary) and connected to the Respitrace. RIP has been validated against ultrasound as a highly reliable method for identifying swallows during breastfeeding (Geddes et al, 2010) and has been used successfully to compare respiratory changes for breast and bottle-feeding in term infants (Mathew, 1989).
Timepoint [4] 336081 0
Control group: a single monitored breastfeed whereby RIP is performed continuously throughout the duration of the feed.
Ankyloglossia group: monitored breastfeeds whereby RIP is performed continuously throughout the duration of the feed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [5] 336082 0
Oxygen saturation levels during breastfeeding
Continuous oxygen saturation monitoring will be performed for the duration of the monitored feeds using pulse oximetry (Radical/MasimoSET V4.1) with a paediatric sensor (LNOP Yi Multisite) attached to the distal end of infant’s foot.
Timepoint [5] 336082 0
Control group: a single monitored breastfeed whereby oxygen saturation monitoring is performed continuously throughout the duration of the feed.
Ankyloglossia group: monitored breastfeeds whereby oxygen saturation monitoring is performed continuously throughout the duration of the feed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [6] 336083 0
Heart rate during breastfeeding
Continuous heart rate monitoring will be performed for the duration of the monitored feeds using pulse oximetry (Radical/MasimoSET V4.1) and a paediatric sensor (LNOP Yi Multisite) attached to the distal end of infant’s foot.
Timepoint [6] 336083 0
Control group: a single monitored breastfeed whereby heart rate monitoring is performed continuously throughout the duration of the feed.
Ankyloglossia group: monitored breastfeeds whereby heart rate monitoring is performed continuously throughout the duration of the feed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment.
Secondary outcome [7] 336084 0
Changes in nipple dimensions following breastfeeding
Nipple length and diameter (anter0-posterior and transverse) will be measured using digital callipers.
Timepoint [7] 336084 0
Control group: nipple dimensions are measured immediately before and immediately after a single monitored breastfeed
Ankyloglossia group: nipple dimensions are measured immediately before and immediately after monitored breastfeeds at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [8] 336085 0
Twenty-four hour milk production
Determined by test-weigh method for each breast. Infants are weighed using electronic scales (BabyWeigh Scale, Medela AG, Baar, Switzerland, sensitive to 2 grams) before and immediately after every breastfeed over a 24 hour period. Milk intake is calculated by subtracting the pre-feed weight of the infant from the post-feed weight. Volumes of breastmilk expressed by the mother, and any breastmilk and/or infant formula fed to the infant are also recorded. Parents perform these measurements in their own home.
Timepoint [8] 336085 0
Control group: 24hr milk production measurement within 7 days of a single monitored breastfeed
Ankyloglossia group: 24hr milk production measurement are recorded on two occasions: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [9] 336086 0
Percentage of available milk removed (PAMR) during breastfeeding
During the 24hr milk production data collection period/s, and at monitored breastfeed sessions, small sample of milk (<5 mL) are collected before and after each breastfeed and breast expression into provided polypropylene plastic vials (Disposable Products, Adelaide, Australia) and analysed for fat concentration (g/L). Use the milk transfer volume data (from the 24hr milk production studies and monitored breastfeed study sessions) together with the results of fat concentration analysis are used to estimate the breast storage capacity and PAMR during the breastfeeds where milk samples were collected.
Timepoint [9] 336086 0
Control group: Breastfeeds during the measurement of 24hr milk production (recorded within 7 days of a single monitored breastfeed) and the single monitored breastfeed
Ankyloglossia group: Breastfeeds during the measurement of 24hr milk production (recorded (up to 10 days before, and 14-21 days after frenotomy) and breastfeeds monitored pre (up to 10 days before) and post (14-21 days after) frenotomy treatment.
Secondary outcome [10] 336087 0
Maternal breastfeeding confidence
Maternal confidence in the ability to breastfeed is measured using the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF; Dennis, 2003), a validated 14 item instrument.
Timepoint [10] 336087 0
Control group: BSES-SF is completed during a single study visit for a monitored breastfeed and again (if the infant is still breastfeeding at the follow-up phone call) at 3 months postnatal
Ankyloglossia group: BSES-SF is completed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment, and again (if the infant is still breastfeeding at the follow-up phone call) at 3 months postnatal.
Secondary outcome [11] 336088 0
Breastfeeding-related pain intensity
The McGill pain questionnaire (MPQ) lists 78 adjectives in 20 groups and 4 classes; a pain rating index is calculated from descriptors that participants select to indicate to their experience of pain associated with breastfeeding.
Timepoint [11] 336088 0
Control group: MPQ is completed during a single study visit for a monitored breastfeed
Ankyloglossia group: MPQ is completed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [12] 336089 0
Pain severity associated with breastfeeding
The Visual Analogue Scale (VAS) requires participants to indicate the severity of breast and/or nipple pain experienced during and between breastfeeds by indicating on a continuous line that ranges from 'no pain at all' to "worst pain imaginable'
Timepoint [12] 336089 0
Control group: VAS is completed during a single study visit for a monitored breastfeed
Ankyloglossia group: VAS is completed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment
Secondary outcome [13] 336090 0
Interference of Pain on Daily Functioning
Section 9 of the Brief Pain Inventory - Short Form (BPI-SF; Cleeland, 1991) is administered to determine the degree to which any breastfeeding pain interferes with daily functioning.
Timepoint [13] 336090 0
Control group: Section 9 of BPI-SF is completed during a single study visit for a monitored breastfeed
Ankyloglossia group: Section 9 of BPI-SF is completed at 2 study visits: pre (up to 10 days before) and post (14-21 days after) frenotomy treatment

Eligibility
Key inclusion criteria
English speaking mothers and their term infants less than 12 weeks of age; mothers who intend to breastfeed for at least 6 months, and infants are predominantly fed breastmilk (breastfeeding and/or expressed breastmilk, infant feeds comprise less than 50% infant formula). Ankyloglossia and breastfeeding difficulty will be identified by a health professional prior to enrolment.
Minimum age
No limit
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers with a history of breast surgery and/or nipple piercing
Infants born <37/40 or <2500 g, acute illness, and/or infection and/or congenital disease or malformation, multiple birth infants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
The primary endpoint of this study is the comparison of intra-oral vacuum of the infants with ankyloglossia pre and post frenotomy. Geddes, Kent et al (1) measured peak (-145 +/- 58 mmHg) and baseline (-64 +/- 45 mmHg) vacuums in infants without oral abnormalities or feeding problems while Prieto, Cardenas et al (2) measured peak vacuums of -197 +/- 10 mmHg. A case series by Geddes, Kent et al (3) included five infants with ankyloglossia who were able to transfer enough milk to satisfy their needs and none of the mothers report any feeding difficulties. Measured values for baseline and peak vacuums were -63 +/- 64 mmHg (range: -3 to -170) and -167 +/- 60 mmHg (range: -113 to -250), respectively.
Sample size calculation: To allow detection of a difference of 60 mmHg with power of 80% (Type I error rate a=0.05) 16 infants will be recruited to each group. However, to increase the detectable difference to 44 mmHg, 30 infants in each group will be recruited. The sample size was calculated based on a two sided paired t-test.
Data analysis: Data will be analysed on an intention to treat basis using R 3.1.1 (or later version) (4) with nlme (5) and lattice (6) packages for linear mix effect models and graphical exploration, respectively. For the monitored breastfeeds, differences in milk transfer volume as well as measured sucking, physiological, and feeding variables, linear mixed effects modeling will be used, with grouping for the random effects at the participant level.

1. Geddes DT, Kent JC, Mitoulas LR, Hartmann PE. Tongue movement and intra-oral vacuum in breastfeeding infants. Early Hum Dev 2008; 84(7): 471-7.
2. Prieto CR, Cardenas H, Salvatierra AM, Boza C, Montes CG, Croxatto HB. Sucking pressure and its relationship to milk transfer during breastfeeding in humans. Journal of reproduction and fertility 1996; 108(1): 69-74.
3. Geddes DT, Kent JC, McClellan HL, Garbin CP, Chadwick LM, Hartmann PE. Sucking characteristics of successfully breastfeeding infants with ankyloglossia: a case series. Acta Paediatr 2010; 99(2): 301-3.
4. R Core Team. R: A language and environment for statistical computing. In: Pinheiro J, Bates D, DebRoy S, Sarkar D, R Core Team, (eds). Vienna, Austria: R Foundation for Statistical Computing, 2009.
5. Pinheiro J, Bates D, DebRoy S, Sarkar D, R Core Team. nlme: Linear and Nonlinear Mix Effects Models. In. R package version 3.1-113 ed, 2009.
6. Sarkar D. Lattice: Multivariate Data Visualization with R. In. New York: Springer, 2008.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/08/2016
Date of last participant enrolment
Anticipated
18/12/2017
Actual
Date of last data collection
Anticipated
28/02/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8388 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 16460 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292482 0
University
Name [1] 292482 0
The University of Western Australia
Country [1] 292482 0
Australia
Primary sponsor type
Individual
Name
A/Prof Donna Geddes
Address
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 291188 0
None
Name [1] 291188 0
Address [1] 291188 0
Country [1] 291188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293947 0
Sharon Perrella
Ethics committee address [1] 293947 0
Ethics committee country [1] 293947 0
Australia
Date submitted for ethics approval [1] 293947 0
Approval date [1] 293947 0
08/07/2016
Ethics approval number [1] 293947 0
RA/4/1/8479
Ethics committee name [2] 297985 0
WA Women & Newborn Health Service Ethics Committee
Ethics committee address [2] 297985 0
Ethics committee country [2] 297985 0
Australia
Date submitted for ethics approval [2] 297985 0
02/02/2016
Approval date [2] 297985 0
05/04/2016
Ethics approval number [2] 297985 0
2016924EW

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

Contacts
Principal investigator
Name 61886 0
A/Prof Donna Geddes
Address 61886 0
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 61886 0
Australia
Phone 61886 0
+61 8 6488 7006
Fax 61886 0
+61 8 6488 7086
Email 61886 0
[email protected]
Contact person for public queries
Name 61887 0
Sharon Perrella
Address 61887 0
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 61887 0
Australia
Phone 61887 0
+61 8 6488 4467
Fax 61887 0
+61 8 6488 7086
Email 61887 0
[email protected]
Contact person for scientific queries
Name 61888 0
Sharon Perrella
Address 61888 0
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 61888 0
Australia
Phone 61888 0
+61 8 6488 4467
Fax 61888 0
+61 8 6488 7086
Email 61888 0
[email protected]

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