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Trial registered on ANZCTR

Registration number

ACTRN12622001031752

Ethics application status

Approved

Date submitted

7/06/2022

Date registered

22/07/2022

Date last updated

22/07/2022

Date data sharing statement initially provided

22/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficacy of physiotherapy treatment in term newborns who have difficulty breastfeeding

Scientific title

Efficacy of the lip out method for breastfeeding outcomes in term newborns who have difficulty breastfeeding

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1279-0551

Trial acronym

Linked study record

Health condition

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

Ankyloglossia

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The day after birth, the newborns and the mother will be evaluated using the Hazelbaker, Lach and VAS scales: based on the score obtained, it is checked whether there are difficulties in breastfeeding and, therefore, it is optimal to participate in the study.
You will be randomly (randomly) assigned to one of two study groups. The intervention group will begin the Physiotherapy treatment based on the "Lip Out" method prior to hospital discharge.
This method consists of specifically addressing the function of breastfeeding in terms of the seal that is made between the baby's mouth and the mother's breast. Oral motor dysfunctions that may be related to ankyloglossia (difficulty in tongue mobility due to a short and/or restrictive frenulum and also due to other alterations) that generate an incorrect sucking pattern will be addressed.
The treatment will be carried out both during suction and at the moment of grasping. What is intended is to relax tensions that may be related to compensatory structures that make it difficult for the tongue to perform a correct function when sucking. Specifically, the posture of the mother at the time of breastfeeding the baby will be corrected, the accessory muscles of the mouth (orbicularis oculi, masseter muscles) will be relaxed and digital longitudinal stretching of the frenulum.
Before hospital discharge, these exercises will be taught to the parents and an exhaustive follow-up will be carried out for one month. The frequency of the sessions will be one hour a week during the first month of life (4 sessions of one hour in total). This follow-up of the baby will be carried out until the first month of life.

After this month of treatment, it will be evaluated again with the same scales to check whether or not there are differences with respect to the initial scores.

Who performs the intervention is a physiotherapist who has 10 years of experience.

Intervention code [1]

Prevention

Intervention code [2]

Rehabilitation

Comparator / control treatment

The control group will not receive physiotherapy treatment to treat the problems derived from alterations at the orofacial level. Instead, they will receive a weekly one-hour physical therapy session during the baby's first month of life (i.e. 4 one-hour sessions per month) in which the parents will be instructed through direct observation of the physical therapist and a written document on the performance of the Shantala massage (performed by the physical therapist). After observing the physiotherapist, they will perform it on the baby under supervision; This will verify the good practice of massage.
Another assessment will be carried out once a month to check if after a certain time the structures at the orofacial level are restructured without the need to receive any treatment.

Control group

Active

Outcomes

Primary outcome [1]

Visual Analog Scale to check the pain experienced by the mother when breastfeeding. The mother will be instructed to mark her perception of pain with an X, considering 0 (null value) and 10 (maximum value).

Timepoint [1]

Before the intervention and one month after the beginning of the intervention

Primary outcome [2]

Lach scale to assess breastfeeding. The following items will be assessed from 0 (null value) to 2 (maximum value), with an intermediate score of 1 (mean value): attachment, swallowing, type of breast and positioning of the baby at the breast. The maximum score will be 10, which means that there would be no risk of early weaning. If the score is less than 9, it indicates the need for support and monitoring of breastfeeding by professionals.

Timepoint [2]

Before the intervention and one month after the beginning of the intervention.

Primary outcome [3]

Hazelbaker scale to assess both the structure and function of the infant's tongue. This instrument is made up of items related to function (lateralization, elevation, width and length extension, cupping, peristalsis and spring of the tongue) and appearance. Each item will be scored from 0 (does not do it) to 2 (does it adequately), with an intermediate score of 1 (does not fully complete that item). If the function score is 14, regardless of appearance, no intervention is necessary. If the function score is 11, Physiotherapy treatment is recommended. Finally, if the score is less than 11, the function is considered impaired, so it is necessary to treat as soon as possible.

Timepoint [3]

Before the intervention and one month after the beginning of the intervention.

Secondary outcome [1]

NIL

Timepoint [1]

NIL

Eligibility

Key inclusion criteria

1. Term newborns (between 37 and 41 weeks of gestation).
2. Both men and women will be selected.
3. Both normal delivery and cesarean section.
4. Infants who have a low score on the initial assessment scale and, therefore, a problem in breastfeeding.
5. The parents of the babies must authorize their participation in the clinical trial, as well as subjecting the baby to low-intervention physiotherapy treatment, signing said authorization in the Informed Consent.

Minimum age

1 Days

Maximum age

7 Days

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Preterm, post-term and low birth weight newborns (less than 2,500 Kg).
2. Newborns who present pathology or have had problems during the immediate prenatal or postnatal period.
3. Patients who do not understand and are unable to fill in the Visual Analogue Scale (VAS).
4. Mothers who trigger problems in the immediate postpartum period and, as a consequence, prevent them from being with the baby in the first hours after birth.
5. Patient who does not want and does not authorize to participate in the study, does not adequately understand the Spanish language.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Before starting the study, the online Randomizer 18 (Research Randomizer, 1997) was used to randomly generate 186 sets of numbers, each of which contained two numbers ranging from 1 to 2 in random order. A total of 186 unique codes were generated based on the 57 sets of {1 and 2}. After signing the consent, a code was randomly chosen for each patient, thus ensuring that the 186 patients were equally distributed into two groups according to the group number of each code: group 1 (experimental group) and group 2 (control group).

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 calculation of the sample size, performed with the Ene 3.0 software, was estimated considering the effectiveness of the physiotherapy technique in infants, for a 95% CI with an alpha error of 5% and a beta error of 20% for an OR to detect of 2. The sample size was 93 patients for each group, that is, a total of 186 patients distributed in 93 individuals for the group that received the physiotherapy technique and 93 patients for the group that did not receive intervention.

With all the variables described above, a database will be created and the statistical treatment will be carried out with the SPSS 27.0 program.
A univariate or descriptive analysis will be performed. For qualitative variables, frequencies will be calculated with their corresponding percentages, and for quantitative variables, central tendency measurements and dispersion measurements (mean, minimum, maximum and standard deviation) will be performed.
In the bivariate analysis, for the comparison of qualitative variables, the Chi-square test (?2) will be used, considering significant a value of p<0.005. For the comparison of means of quantitative variables, after a normality test (Kolmogorov-Smirnov test), parametric or non-parametric tests will be used, as appropriate. For variables with normal distribution, the T-Student test for independent variables, the T-Student test for paired variables and one-factor ANOVA with their corresponding "post hot" test will be confirmed. For variables that follow a non-normal distribution, the Mann-Whitney U test to compare independent variables, the Wincoxon test for paired variables, the Kruskal-Wallis test for more than two independent variables, and the Friedman test for more than two paired variables.
The multivariate analysis will be performed using binary logistic regression and multiple linear regression.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

5/09/2022

Actual

Date of last participant enrolment

Anticipated

1/03/2023

Actual

Date of last data collection

Anticipated

31/03/2023

Actual

Sample size

Target

186

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Almería

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Gemma María López Segura

Address [1]

Hermandad donantes de sangre S/N Barrio Torrecárdenas, 04009, Almería

Country [1]

Spain

Primary sponsor type

Individual

Name

Gemma Mª López Segura

Address

Hermandad donantes de sangre S/N Barrio Torrecárdenas, 04009, Almería

Country

Spain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Provincial Research Ethics Committee of Almería (CEI/CEIm)

Ethics committee address [1]

Brotherhood of Blood Donors Street, s/n, 04009 Almería

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

25/04/2022

Approval date [1]

27/04/2022

Ethics approval number [1]

35/2022

Summary

Brief summary

Breastfeeding should be the biological norm in the newborn since it brings many benefits to both the mother and the baby. The World Health Organization recommends offering the baby exclusively breast milk until six months; From this age, complementary feeding would begin to be introduced. There may be different circumstances that cause difficulty in establishing breastfeeding, such as an alteration in the level of the skeletal or cranial muscle in the baby derived from a complicated delivery.
Physiotherapy specialized in breastfeeding relates the problems that may arise from such a process in the baby along with the difficulty that may exist in adapting to the mother's body or the inability of the orofacial structure to develop the action of suckling.
The objective of the work is to identify these problems in the baby a priori, carry out an assessment and treat these difficulties as soon as possible, since the first days are the key to successfully establishing breastfeeding.
Parents often go to a physical therapy consultation to assess these structures too late, when there is already a problem in the production of breast milk. That is why it is important to intervene early when an erroneous suction pattern has not yet been established.
For this, a Controlled Clinical Trial has been proposed with two groups: an experimental group, which will be assessed using the Hazelbacker scale to identify that there is an ankyloglossia that makes it difficult to hold on to the chest correctly. Subsequently, a physiotherapy intervention will be carried out applying the Lip Out method for a period of one month and, finally, we will evaluate again using the same scale to check if there is improvement or not, after carrying out the treatment. The control group will not receive physiotherapy treatment to assess whether, after this month, the structures will recover spontaneously without receiving any treatment.
It is necessary to investigate the benefits of physiotherapy treatment in problems related to breastfeeding in order to create evidence and establish treatment protocols in the first days of the newborn's life.
The hypothesis of the study is as follows:
Full-term newborns who present ankyloglossia and receive early physiotherapy treatment will benefit from learning a correct suction pattern, which will be reflected in a good start to breastfeeding.
The development of the "Lip Out" physiotherapy technique in patients who present difficulties in breastfeeding will be reflected in the improvement of the mobility, strength and function of the orofacial structures; as a consequence, the pain reflected by the mother during attachment to the breast and/or during feeding will decrease.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Gemma María López Segura

Address

Hermandad donates de sangre S/N Barrio Torrecárdenas, 04009, Almería.

Country

Spain

Phone

+34610024516

Fax

gemalose@gmail.com

Contact person for public queries

Name

Gemma María López Segura

Address

Hermandad donates de sangre S/N Barrio Torrecárdenas, 04009, Almería.

Country

Spain

Phone

+34610024516

Fax

gemalose@gmail.com

Contact person for scientific queries

Name

Gemma María López Segura

Address

Hermandad donates de sangre S/N Barrio Torrecárdenas, 04009, Almería.

Country

Spain

Phone

+34610024516

Fax

gemalose@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16333	Ethical approval					384156-(Uploaded-07-06-2022-22-05-19)-Study-related document.pdf

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No additional documents have been identified.

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