The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips

March 25, 2024 updated by: Sibel Küçükoğlu

The Effect of Breastmilk Smelling and Tasting & Smelling First Breastfeeding Practices on Sucking Success and Early Period Feeding Clues of Term Newborns

The study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time.

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

In the literature, there are many studies examining the odor effect or odor and taste effect during gavage feeding of premature and low birth weight infants hospitalized in the Neonatal Intensive Care Unit (NICU). However, no study was found to examine the effect of smell and taste application on breastfeeding success and early feeding cues during initiation of breastfeeding for the first time in healthy term newborns. It is clear that sick newborns need much more support and intervention in the transition to oral feeding. However, the low rates of breastfeeding in our country indicate that the use of effective and facilitating methods to initiate and maintain breastfeeding is also necessary for term and healthy infants. Therefore, this study may guide healthcare professionals on the effectiveness of odor and taste stimulation for early breastfeeding and provide ideas for designing new research and projects.

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.
72

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 Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42100
        • Selcuk University

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:

  • For the mother
  • Having a term and healthy baby,
  • No communication and language problems,
  • No maternal illness preventing breastfeeding (active chemotherapy, HIV positive, neurological or psychological problems, etc.),
  • Willingness to breastfeed, For the baby;
  • Not having a disease condition that prevents breastfeeding (cleft palate, cleft lip, galactotemia, choanal atresia, etc.),
  • Being at normal birth weight (2500gr-4000gr),
  • Apgar score of 7 and above.

Exclusion Criteria:

  • Under 18 and over 40 years of age,
  • Development of postpartum complications (in mother or baby),
  • Multiple pregnancy.

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: Supportive Care
  • 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: Odor stimulation group
In the breast milk odor stimulation group, one or two drops of breast milk were placed on a sponge in accordance with the literature. Breast milk was obtained from each infant's own mother by hand expressing. The mothers were asked to express two drops of breast milk from their breasts onto the sponge. The sponge on which the breast milk was dripped was placed as close to the baby's nose as possible without touching the baby's nose. Since breast milk odor stimulation is recommended to be given to the baby for 1 minute in the literature, the baby was allowed to smell the odor of breast milk for 1 minute. The baby was then given to the mother for breastfeeding and breastfeeding was initiated as in routine practice.
Behavioral: Breast Milk Odor Stimulation
In the breast milk odor stimulation group, one or two drops of breast milk were placed on a sponge in accordance with the literature. Breast milk was obtained from each infant's own mother by hand expressing. The mothers were asked to express two drops of breast milk from their breasts onto the sponge. The sponge on which the breast milk was dripped was placed as close to the baby's nose as possible without touching the baby's nose. Since breast milk odor stimulation is recommended to be given to the baby for 1 minute in the literature, the baby was allowed to smell the odor of breast milk for 1 minute. The baby was then given to the mother for breastfeeding and breastfeeding was initiated as in routine practice.
Experimental: Odor + Taste Stimulation Group
In this group in which the breast milk sniffing method was applied; two drops of breast milk were dripped onto a sponge in accordance with the literature and this sponge was placed as close to the nose as possible without touching the nose and the baby was allowed to smell the smell of breast milk for about 1 minute. Then the baby was given to the mother. The mother was asked to express milk manually and to apply/drip approximately 0.2 ml (approximately two drops) of the expressed colostrum starting from the tip of the baby's tongue, along the tongue surface, on both cheeks of the baby, as applied in studies using oral colostrum as a reference. The mother was also asked to express a drop of milk from her breast and manually apply it to the areola. Breastfeeding was then initiated as in routine practice.
Behavioral: Stimulation of Breast Milk Smell and Taste
In this group in which the breast milk sniffing method was applied; two drops of breast milk were dripped onto a sponge in accordance with the literature and this sponge was placed as close to the nose as possible without touching the nose and the baby was allowed to smell the smell of breast milk for about 1 minute. Then the baby was given to the mother. The mother was asked to express milk manually and to apply/drip approximately 0.2 ml (approximately two drops) of the expressed colostrum starting from the tip of the baby's tongue, along the tongue surface, on both cheeks of the baby, as applied in studies using oral colostrum as a reference. The mother was also asked to express a drop of milk from her breast and manually apply it to the areola. Breastfeeding was then initiated as in routine practice.
No Intervention: Control Group
The control group did not receive any intervention other than the routine initiation of breastfeeding at the clinic. They were provided with breastfeeding education by the lactation counselor.

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
Introductory Information Form
Time Frame: First measurement-First day of hospitalization
This form was created by the researchers by utilizing the literature. The descriptive information form consisted of a total of 12 questions inquiring about the mother's descriptive information (maternal age, education level, occupation, place of residence, economic status), obstetric information (mode of delivery, number of deliveries, breastfeeding experience, time of first breastfeeding) and infant information (infant's gender, birth weight, gestational week, Apgar score at 5 min).
First measurement-First day of hospitalization
Early Feeding Tips Scale
Time Frame: First measurement-first breastfeeding of the first day
The Turkish validity and reliability study of the scale developed by Thoyre, Ahaker, and Pridham in 2005 was conducted by Girgin et al. in 2021. The early feeding cues scale consists of 19 items and 5 subcategories and is evaluated based on observation. These categories are respiratory regulation, oral-motor function, swallowing coordination, alertness-energy status and physiological stability.The lowest total score is 19 and the highest is 57. A higher score indicates the presence of early feeding cues and a lower score indicates a decrease in early feeding cues.
First measurement-first breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
Time Frame: First measurement-first breastfeeding of the first day
It is a measurement tool developed by Jansen and Wallece in 1993, which is similar to the APGAR scoring system in terms of scoring. Turkish validity and reliability studies of the LATCH breastfeeding diagnosis form were conducted by Demirhan in 1997 , Koyun in 2001 , and Yenal and Okumuş in 2003. Each criterion in the scale is given a score between 0 and 2 and the lowest score is 0 and the highest score is 10. An increase in the scores obtained from the scale indicates breastfeeding success.
First measurement-first breastfeeding of the first day
Early Feeding Tips Scale
Time Frame: Second measurement-Second breastfeeding of the first day
The Turkish validity and reliability study of the scale developed by Thoyre, Ahaker, and Pridham in 2005 was conducted by Girgin et al. in 2021. The early feeding cues scale consists of 19 items and 5 subcategories and is evaluated based on observation. These categories are respiratory regulation, oral-motor function, swallowing coordination, alertness-energy status and physiological stability.The lowest total score is 19 and the highest is 57. A higher score indicates the presence of early feeding cues and a lower score indicates a decrease in early feeding cues.
Second measurement-Second breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
Time Frame: Second measurement-Second breastfeeding of the first day
It is a measurement tool developed by Jansen and Wallece in 1993, which is similar to the APGAR scoring system in terms of scoring. Turkish validity and reliability studies of the LATCH breastfeeding diagnosis form were conducted by Demirhan in 1997 , Koyun in 2001 , and Yenal and Okumuş in 2003. Each criterion in the scale is given a score between 0 and 2 and the lowest score is 0 and the highest score is 10. An increase in the scores obtained from the scale indicates breastfeeding success.
Second measurement-Second breastfeeding of the first day
Early Feeding Tips Scale
Time Frame: Third measurement-Third breastfeeding of the first day
The Turkish validity and reliability study of the scale developed by Thoyre, Ahaker, and Pridham in 2005 was conducted by Girgin et al. in 2021. The early feeding cues scale consists of 19 items and 5 subcategories and is evaluated based on observation. These categories are respiratory regulation, oral-motor function, swallowing coordination, alertness-energy status and physiological stability.The lowest total score is 19 and the highest is 57. A higher score indicates the presence of early feeding cues and a lower score indicates a decrease in early feeding cues.
Third measurement-Third breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
Time Frame: Third measurement-Third breastfeeding of the first day
It is a measurement tool developed by Jansen and Wallece in 1993, which is similar to the APGAR scoring system in terms of scoring. Turkish validity and reliability studies of the LATCH breastfeeding diagnosis form were conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003. Each criterion in the scale is given a score between 0 and 2 and the lowest score is 0 and the highest score is 10. An increase in the scores obtained from the scale indicates breastfeeding success.
Third measurement-Third breastfeeding of the first day

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.
Sibel Küçükoğlu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Institutes of Turkey

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.
  • Study Director: Sibel Kucukoglu, Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 15, 2022

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.
September 15, 2022

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.
November 15, 2023

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).
March 15, 2024

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.
March 25, 2024

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.
April 2, 2024

Study Record Updates

Last Update Posted (Actual)

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.
April 2, 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.
March 25, 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.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • SelcukUni2542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings