- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06341153
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
72
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
Collaborators
Investigators
- 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
- Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
- Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw. 2005 May-Jun;24(3):7-16. doi: 10.1891/0730-0832.24.3.7.
- Varendi H, Porter RH. Breast odour as the only maternal stimulus elicits crawling towards the odour source. Acta Paediatr. 2001 Apr;90(4):372-5.
- Raimbault C, Saliba E, Porter RH. The effect of the odour of mother's milk on breastfeeding behaviour of premature neonates. Acta Paediatr. 2007 Mar;96(3):368-71. doi: 10.1111/j.1651-2227.2007.00114.x.
- Yildiz A, Arikan D, Gozum S, Tastekin A, Budancamanak I. The effect of the odor of breast milk on the time needed for transition from gavage to total oral feeding in preterm infants. J Nurs Scholarsh. 2011 Sep;43(3):265-73. doi: 10.1111/j.1547-5069.2011.01410.x. Epub 2011 Jul 25.
- Aykanat Girgin B, Gozen D, Uslubas R, Bilgin L. The Evaluation of Oral Feeding in Preterm Infants: Turkish Validation of the Early Feeding Skills Assessment Tool. Turk Arch Pediatr. 2021 Sep;56(5):440-446. doi: 10.5152/TurkArchPediatr.2021.21008.
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)
July 15, 2022
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 25, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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