Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipplesoreness (RCT WHO LATCH)

December 4, 2024 updated by: Shazia taj, University of Health Sciences Lahore

Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipple-soreness Among Primipara Mothers

There is a significance difference in latch and Nipple-soreness score after intervention in control and interventional. Study population is primiparous mothers.group.interventional group received Breastfeeding supportive educational and training session.control group received hospital routine care.Randomised control trial designed selected. Sample size 60 participants. Latch and nipplesoreness rating scale used for data collection. statistical package of social sciences used for data analysis.outcome utilised in clinical and educative health care system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Breastfeeding is a natural physiological process but initial critical step on a child s path to a healthy future. Breastfeeding is beneficial to mother, child and society. For this purpose WHO Re-established global breastfeeding culture to promote exclusive breastfeeding (EBF) up-to first 6 months of life 50% by year 2025.Globally Among primiparous 33% mothers experienced breastfeeding problems in first two weeks postpartum. Determinants of premature termination of EBF are nipple soreness, inadequate latch techniques, breast engorgement, and lack of educative supportive system on preventive measures. In Pakistan IMR rate is 55.77% in 2022, major cause is failure to initiate and continuity in breast feeding. Infants get EBF 48% limited to 3 month. One of the significant factor is sore nipples that preeminent by the poor latch contributing 72%, secondary to infants improper sucking. It is hypothesized that ensuring sustain breast feeding by implementing the Planned, educational supportive training sessions, close observation to identify latch related problems and correct them promptly to prevent from nipple soreness, and predict for EBF. The aim of study to determine effectiveness of educational and hand on practice breastfeeding training session to prevent breastfeeding problems that ensure successful breastfeeding journey. Rational of this study is objectively assess the breastfeeding status and take corrective measure before problem become complicated by giving educational breastfeeding training session on preventive basis. However least literature existed on such preventive basis training sessions in countries that have high IMR. The study design will be "Randomized Control Trial." Sample size will comprise of 60 Participants 30 in control and 30 in interventional. Study participants will be selected by non-probability purposive sampling design and allocated in control group and interventional group by Simple Random sampling technique. After signing the informed consent form by participants Demographical data will be elicited. Nipple soreness rating scale and LATCH scoring system will be used to assess the feeding status. Observations will be recorded. SPSS will be used for data analysis and results compare between groups. Independent sample t test will be used to compare the effects of post test score of educational breastfeeding training session. Repeated measure of ANOVA will be used to compare differences between interventional group and control group for weekly follow up if data is normally distributed. A p-value of <0.05 will be considered statistically significant. Outcome utilization of this study, Participants may use independently breastfeeding skills and achieve sustain breastfeeding process. Health care Administrator may make a policy to implement LATCH charting system, (like APGAR score). LATCH scoring system may include in nursing and medical education. Limitations of this study may use limited sample size and lack of follow-ups of infant up-to 6 months. More studies may need to confirm the findings for long term benefits of such training session

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • University of Health Sciences Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • primiparous mothers in early postpartum with healthy infant outcomes.

Exclusion Criteria:

  • Sick mothers.
  • Mother with anomaly infants.
  • Mothers with contraindication for breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Educational interventional Arm.
Interventional arm received educational supportive breastfeeding and hand on training session on Latch techniques according to UNICEF guideline.
Behavioral: Educational breastfeeding traning session
Educational breastfeeding training session base on dialogical, visual attractive and training session on Proper LATCH techniques and breastfeeding positions to prevent from nipplesoreness.
Other Names:
  • Breastfeeding hands on training session.
No Intervention: Control routine hospital care Arm.
Control. No interventions receive hospital routine care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographical data, infant Latch on breast.
Time Frame: One month

Demographical data consisting of socio-demographic characteristics of participants

1: LATCH scoring system. A systematic breastfeeding assessment, diagnostic and evaluating tool for individual breastfeeding sessions. The tool assigns a numerical score, 0, 1, 2, and includes five key elements of breastfeeding.LATCH: 1. L for infant's ability to latch onto the breast, 2 .A for the presence of audible swallowing of the infant at the breast, 3.T for mother's nipple type, 4.C for mother's sense of comfort,5.H for holding.The total score range from 0 to 10; higher score, the more chances of successful effective breastfeeding. A LATCH score of 0-3 is regarded as poor, 4-7 as moderate/fair, and 8-10 as good/well, during early postpartum. The mothers observed for breastfeeding LATCH by 5-10 minute.
One month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nipplesoreness
Time Frame: One month
The nipple soreness rating scale used to determine the pain severity and fissure/cracks on nipples during breastfeeding, 0 = No pain, no tenderness, normal in colour (normal findings), 4 = severe pain, nipple cracked. (Nipple soreness score from 1 to 4 are considered incidence of nipple soreness).
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Health Sciences Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shazia Taj, PG student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LATCH RCT 2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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