An interventional study of Pediatric Manual Physiotherapy and Conventional Breastfeeding Support and Home Exercises in Breastfeading, Physiotherapy and Difficulties, sponsored by Fundacion Miguel Servet. Not yet recruiting. Open to participants aged 2 Days to 3 Months. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Other
Breastfeeding difficulties may affect both infants and mothers, particularly following instrumental vaginal delivery using forceps or vacuum extraction. Some infants may experience restricted neck movement or muscle tension that could interfere with positioning, attachment to the breast, and effective breastfeeding. Mothers may also experience pain during feeding.
This clinical trial aims to determine whether adding manual physiotherapy to conventional breastfeeding support improves breastfeeding performance in infants born following instrumental vaginal delivery.
The study will include 126 mother-infant pairs experiencing breastfeeding difficulties. Eligible infants must have been born at term, be no older than three months at enrollment, and have been delivered using forceps or vacuum extraction.
Participants will be randomly assigned to one of two groups. Both groups will receive conventional breastfeeding guidance and a home exercise program. In addition, infants in the experimental group will receive six sessions of gentle manual physiotherapy, approximately once a week. Infants in the control group will not receive the study-specific manual physiotherapy treatment.
Breastfeeding performance will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT), which evaluates infant positioning, attachment, sucking, and swallowing. The study will also assess infant neck movement, maternal pain during breastfeeding, and infant irritability.
Assessments will take place at the beginning of the study (Day 0), on Days 15 and 30, at the end of the treatment period (Day 37), and when the infant reaches six months of age. The main comparison between the two groups will be the change in breastfeeding performance from Day 0 to Day 37.
The study hypothesis is that infants receiving manual physiotherapy in addition to conventional breastfeeding support will show greater improvement in breastfeeding performance than infants receiving conventional support alone.
The results may help determine whether manual physiotherapy is a useful complementary treatment for breastfeeding difficulties following instrumental vaginal delivery.
# Detailed Description
## Background and Rationale
Breastfeeding requires coordinated oral, facial, cranial, and cervical musculoskeletal function in the infant. Effective breastfeeding depends on appropriate positioning, attachment, sucking, and swallowing, as well as maternal comfort during feeding.
Infants born following instrumental vaginal delivery, including forceps-assisted or vacuum-assisted delivery, may experience musculoskeletal alterations affecting the cranio-cervical and orofacial regions. These alterations may contribute to difficulties with breastfeeding positioning, attachment, sucking, and feeding effectiveness.
Manual physiotherapy targeting infant musculoskeletal function may provide an additional therapeutic approach alongside conventional breastfeeding support. Further randomized controlled trials are needed to evaluate its effectiveness using standardized breastfeeding assessments and quantitative measures of cervical mobility.
The primary objective is to determine whether manual physiotherapy, in addition to conventional breastfeeding support, improves breastfeeding performance compared with conventional breastfeeding support alone in mother-infant dyads experiencing breastfeeding difficulties following instrumental vaginal delivery.
The primary outcome will be the change in the Bristol Breastfeeding Assessment Tool (BBAT) total score from baseline (Day 0) to Day 37.
Secondary objectives include evaluating changes in infant cervical range of motion, maternal pain intensity during breastfeeding, and infant irritability; assessing clinical changes at Days 15 and 30; and evaluating subsequent outcomes when the infant reaches six months of chronological age.
## Study Design
This study is a prospective, randomized, controlled clinical trial with two parallel groups, blinded outcome assessment, and blinded statistical analysis.
A total of 126 mother-infant dyads will be recruited, with 63 participants allocated to each study group.
Eligible infants must have been born following instrumental vaginal delivery, including forceps-assisted or vacuum-assisted delivery, and must be no older than three months at enrollment.
Participants will be randomly assigned in a 1:1 ratio to the experimental or control group using a computer-generated randomization sequence.
The experimental group will receive six sessions of manual physiotherapy, delivered approximately once weekly, in addition to conventional breastfeeding support and a home exercise program.
The control group will receive conventional breastfeeding support and a home exercise program without the study-specific manual physiotherapy intervention.
Clinical outcome assessments will be conducted at five time points:
Days 0, 15, 30, and 37 will be calculated individually from each participant's baseline date. The six-month follow-up assessment will be scheduled according to the infant's date of birth.
Recruitment is planned from November 1 to December 31, 2026.
## Blinding and Bias Minimization
An independent physiotherapist, blinded to treatment allocation, will perform all outcome assessments in both study groups.
A second physiotherapist will administer the manual physiotherapy intervention to infants in the experimental group and will not participate in outcome assessment.
At visits coinciding with treatment sessions, the blinded outcome assessor will complete all clinical assessments before the treating physiotherapist administers the intervention.
Due to the nature of the intervention, the treating physiotherapist and participating families cannot be blinded. Families will be instructed not to disclose their treatment allocation to the blinded assessor.
Statistical analyses will be conducted by a statistician who is a member of the research team but will remain blinded to treatment allocation.
The statistician will receive a coded dataset identifying the study groups using neutral labels, such as Group A and Group B, without disclosure of which group received manual physiotherapy.
The allocation code will remain concealed until the prespecified statistical analyses have been completed and the results finalized.
## Study Population and Recruitment
The study population will consist of mother-infant dyads experiencing breastfeeding difficulties following instrumental vaginal delivery.
Only infants born through forceps-assisted or vacuum-assisted vaginal delivery will be eligible.
Infants must be no older than three months of chronological age at enrollment.
The infant's date of birth and exact postnatal age at enrollment will be recorded.
Written informed consent will be obtained from parents or legal guardians before participation.
Eligibility Criteria
Inclusion Criteria
- Mother-infant dyads experiencing breastfeeding difficulties.
- Infants born following instrumental vaginal delivery using forceps or vacuum extraction.
- Infants aged three months or younger at enrollment.
- Infants born at term, at or after 37 completed weeks of gestation.
Exclusion Criteria
- Infants diagnosed with ankyloglossia.
Breastfeeding performance will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT).
The BBAT evaluates four components of breastfeeding: positioning, attachment, sucking, and swallowing.
Each component is scored from 0 to 2, producing a total score ranging from 0 to 8. Higher scores indicate better breastfeeding performance.
The primary endpoint will be the between-group difference in the change in BBAT total score from baseline (Day 0) to Day 37.
The assessment will be performed during an observed breastfeeding session by the independent physiotherapist blinded to treatment allocation.
Additional BBAT assessments will be conducted at Days 15 and 30 and when the infant reaches six months of chronological age, provided that a breastfeeding session can be observed.
## Infant Cervical Range of Motion Assessment
Infant cervical range of motion will be assessed using the Baiobit motion measurement system.
Measurements will include right and left cervical rotation and right and left cervical lateral flexion, recorded in degrees.
A standardized measurement procedure adapted to infant age and clinical condition will be established before recruitment, including positioning, device placement, measurement conditions, and safety precautions.
Assessments will be performed at Days 0, 15, 30, and 37 and at six months of infant age.
## Maternal Pain Assessment
Maternal pain intensity during breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain).
Immediately after the observed breastfeeding session, the mother will indicate the intensity of pain experienced during that specific feeding.
The score will be recorded in millimeters, with higher scores indicating greater pain intensity.
Assessments will be performed at Days 0, 15, 30, and 37 and at six months of infant age when breastfeeding can be observed.
## Infant Irritability Assessment
Infant irritability will be assessed through maternal reporting.
Persistent crying lasting at least three hours per day will be considered in the assessment.
Irritability will be recorded as a dichotomous variable (yes/no).
Assessments will be performed at Days 0, 15, 30, and 37 and when the infant reaches six months of age.
## Study Interventions
### Control Group: Conventional Breastfeeding Support
Mother-infant dyads allocated to the control group will receive individualized conventional breastfeeding support, including guidance on breastfeeding positioning, infant attachment, maternal comfort, and feeding effectiveness.
Parents will also receive instructions for a home exercise program according to the study protocol.
The control group will not receive the study-specific manual physiotherapy intervention.
No scheduled telephone follow-up calls will be included.
Mother-infant dyads allocated to the experimental group will receive the same conventional breastfeeding support and home exercise guidance as the control group.
In addition, infants will receive six manual physiotherapy sessions delivered approximately once weekly.
The intervention will include:
All techniques will be adapted to the infant's clinical condition and tolerance and performed by a qualified physiotherapist trained in the study protocol.
The treating physiotherapist will not participate in outcome assessment.
## Treatment and Assessment Schedule
The experimental group will follow the schedule below:
The intervals between treatment sessions will be approximately seven to eight days.
On Days 0, 15, 30, and 37, the blinded outcome assessor will complete all clinical assessments before the treating physiotherapist administers the scheduled manual physiotherapy session.
Participants in the control group will undergo the same clinical assessments on Days 0, 15, 30, and 37 and at six months of infant age, without receiving the study-specific manual physiotherapy intervention.
The primary outcome will be assessed on Day 37, immediately before the sixth and final manual physiotherapy session.
## Outcome Measures
### Primary Outcome
**Change in Breastfeeding Performance Assessed by the Bristol Breastfeeding Assessment Tool (BBAT)**
Breastfeeding performance will be measured using the BBAT total score, ranging from 0 to 8 points, with higher scores indicating better breastfeeding performance.
The primary endpoint will be the between-group difference in the change in BBAT total score from baseline to Day 37.
Time Frame: Baseline (Day 0) and Day 37.
### Secondary Outcomes
**1. Change in Infant Cervical Range of Motion**
Right and left cervical rotation and lateral flexion will be measured in degrees using the Baiobit motion measurement system.
Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age.
**2. Change in Maternal Pain Intensity During Breastfeeding**
Maternal pain intensity will be measured using a 100-mm Visual Analog Scale (VAS).
The assessment will refer specifically to pain experienced during the observed breastfeeding session.
Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age when breastfeeding can be observed.
**3. Change in Infant Irritability**
Infant irritability will be assessed through maternal reporting and recorded as a dichotomous variable (yes/no).
Persistent crying lasting at least three hours per day will be considered in the assessment.
Time Frame: Baseline (Day 0), Days 15, 30, and 37, and six months of infant age.
**4. Breastfeeding Performance at Intermediate and Follow-up Assessments**
BBAT total scores will also be assessed at Days 15 and 30 and when the infant reaches six months of chronological age, provided that breastfeeding can be observed.
Time Frame: Days 15 and 30 and six months of infant age.
## Statistical Analysis
The primary analysis will compare the change in BBAT total score from baseline (Day 0) to Day 37 between the experimental and control groups.
An appropriate statistical model will be used to estimate the treatment effect and its 95% confidence interval, taking into account baseline BBAT score and the bounded nature of the outcome scale.
Secondary longitudinal analyses will assess BBAT scores at Days 15 and 30 and at the six-month follow-up, where available.
Changes in infant cervical range of motion and maternal pain intensity measured using the VAS will be analyzed using appropriate models for repeated measurements.
Infant irritability will be analyzed using statistical methods appropriate for repeated binary outcomes.
The infant's postnatal age at enrollment will be recorded and considered as a potential covariate because participants may enter the study at different ages.
Missing data and reasons for unavailable assessments will be documented, particularly when breastfeeding cannot be observed at the six-month follow-up.
The prespecified statistical analyses will be conducted by a statistician blinded to treatment allocation. The treatment code will be revealed only after these analyses have been finalized.
## Ethical Considerations
The study protocol will be submitted to the appropriate Research Ethics Committee for approval before recruitment begins.
Written informed consent will be obtained from parents or legal guardians before enrollment.
Participation will be voluntary, and families may withdraw at any time without affecting access to usual healthcare.
Adverse events and unexpected responses associated with the intervention will be documented and managed according to the approved study protocol.
## Study Significance
This randomized controlled trial will evaluate whether manual physiotherapy improves breastfeeding performance in infants aged three months or younger who experience breastfeeding difficulties following instrumental vaginal delivery.
The primary endpoint at Day 37 will allow comparison of changes in breastfeeding performance between the experimental and control groups near completion of the intervention period.
Secondary assessments will provide information about cervical mobility, maternal pain, and infant irritability, while the six-month follow-up will allow evaluation of subsequent clinical outcomes.
The use of blinded outcome assessment and blinded statistical analysis is intended to strengthen the methodological quality of the study.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 126 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Fundacion Miguel Servet is the lead sponsor of 48 studies on the registry; 21 are open to participants now.
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Infants aged 3 months or younger at the time of enrollment.
Infants born at full term (37 weeks of pregnancy or later).
Infants delivered vaginally with the assistance of forceps or vacuum extraction.
Mother-infant pairs experiencing breastfeeding difficulties.
Mothers who intend to breastfeed their infants exclusively.
Parents or legal guardians who provide written to participate.
Exclusion Criteria:
Infants born before 37 weeks of pregnancy.
Infants older than 3 months at enrollment.
Infants born by cesarean section or by vaginal delivery without forceps or vacuum assistance.
Infants with a diagnosed medical condition that prevents safe participation in the study or significantly affects their ability to breastfeed.
Mother-infant pairs who cannot attend the scheduled treatment and assessment visits.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants in the experimental group will receive six sessions of gentle manual physiotherapy in addition to conventional breastfeeding support and a home exercise program. Physiotherapy sessions will be scheduled on Days 0, 7, 15, 22, 30, and 37. The intervention will target cranio-cervical, orofacial, and related musculoskeletal structures. Clinical assessments will be conducted on Days 0, 15, 30, and 37, with an additional follow-up when the infant reaches six months of age.
Procedure: Pediatric Manual Physiotherapy
Mother-infant dyads in the control group will receive conventional breastfeeding support, including guidance on breastfeeding positioning, infant attachment, maternal comfort, and a home exercise program. Infants in this group will not receive the study-specific manual physiotherapy intervention. Clinical assessments will be conducted on Days 0, 15, 30, and 37, with an additional follow-up when the infant reaches six months of age.
Behavioral: Conventional Breastfeeding Support and Home Exercises
Six sessions of gentle pediatric manual physiotherapy delivered approximately once weekly on Days 0, 7, 15, 22, 30, and 37. The intervention includes individualized manual techniques targeting cranio-cervical, orofacial, and related musculoskeletal structures, adapted to the infant's clinical condition and tolerance. Treatment is provided by a physiotherapist trained in the study protocol.
Individualized conventional breastfeeding support, including guidance on infant positioning, attachment to the breast, maternal comfort, and strategies to improve feeding effectiveness. Parents will also receive instructions for a home exercise program according to the study protocol. This intervention will be provided to participants in both study groups.
Change from Baseline in Bristol Breastfeeding Assessment Tool. Total Score at Day 37
Breastfeeding performance will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT), which evaluates four components: positioning, attachment, sucking, and swallowing. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 8 points. A score of 0 indicates the greatest breastfeeding difficulties, while a score of 8 indicates the best breastfeeding performance. Higher scores indicate better breastfeeding performance. The primary outcome is the change in total BBAT score from baseline (Day 0) to Day 37, compared between the experimental and control groups. A positive change indicates improvement in breastfeeding performance.
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in Infant Cervical Range of Motion at Day 37
Infant cervical range of motion will be measured in degrees using the Baiobit motion analysis device. Cervical rotation to the right and left and lateral flexion to the right and left will be assessed separately. For each movement direction, change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in cervical range of motion. Measurements will be reported in degrees (°).
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in Maternal Breastfeeding Pain Assessed by the Visual Analog Scale (VAS) at Day 37
Maternal pain associated with breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS) immediately after an observed breastfeeding session. The scale ranges from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity. Change from baseline to Day 37 will be calculated as the Day 37 score minus the baseline score. Negative change values indicate a reduction in maternal pain.
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in the Proportion of Infants with Irritability at Day 37
Infant irritability will be assessed through maternal report using a binary (Yes/No) measure. Irritability will be defined as persistent crying for three or more hours per day. Infants meeting this criterion will be classified as having irritability (Yes), while those not meeting the criterion will be classified as not having irritability (No). The proportion of infants with irritability will be compared between the experimental and control groups at baseline and Day 37.
Time frame: Baseline (Day 0) and Day 37
Proportion of Infants Receiving Any Breastfeeding at Six Months of Age
Breastfeeding status will be assessed when the infant reaches six months of chronological age, calculated from the date of birth. Mothers will report whether their infant is receiving any breast milk at the time of assessment. Infants will be classified as receiving any breastfeeding (Yes) or not receiving breastfeeding (No). The proportion of infants receiving any breastfeeding will be compared between the experimental and control groups.
Time frame: At six months of chronological age
Change from Baseline in Right Cervical Rotation Range of Motion at Day 37
Infant cervical rotation to the right will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in right cervical rotation range of motion.
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in Left Cervical Rotation Range of Motion at Day 37
Infant cervical rotation to the left will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in left cervical rotation range of motion.
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in Right Cervical Lateral Flexion Range of Motion at Day 37
Infant cervical lateral flexion to the right will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in right cervical lateral flexion range of motion.
Time frame: Baseline (Day 0) and Day 37
Change from Baseline in Left Cervical Lateral Flexion Range of Motion at Day 37
Infant cervical lateral flexion to the left will be measured in degrees using the Baiobit motion analysis device. The change from baseline to Day 37 will be calculated as the Day 37 measurement minus the baseline measurement. Positive change values indicate an increase in left cervical lateral flexion range of motion.
Time frame: Baseline (Day 0) and Day 37
Maternal Breastfeeding Pain Assessed by the Visual Analog Scale (VAS) at Infant Age Six Months
Maternal pain associated with breastfeeding will be assessed using a 100-mm Visual Analog Scale (VAS) immediately after an observed breastfeeding session when the infant reaches six months of chronological age. The scale ranges from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity. The VAS score will be recorded only when a breastfeeding session can be observed. Mothers who are no longer breastfeeding will not be assigned a VAS pain score. Maternal pain scores at six months of infant age will be compared between the experimental and control groups.
Time frame: At six months of infant chronological age (calculated from date of birth)
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Fundacion Miguel Servet