BreastfeedingNCT06341153
The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips
A study testing Breast Milk Odor Stimulation and Stimulation of Breast Milk Smell and Taste in people with Breastfeeding and Odors, Body, run by Sibel Küçükoğlu at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Odors, Body, Newborn; Vitality
- What is being tested?
- Breast Milk Odor Stimulation and Stimulation of Breast Milk Smell and Taste
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Under 18 and over 40 years of age,
- Development of postpartum complications (in mother or baby),
- Multiple pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breastfeeding, Odors, Body, Newborn; Vitality
- Being tested
- Breast Milk Odor Stimulation, Stimulation of Breast Milk Smell and Taste
- Medical subject headings
- Breast Feeding, Body Odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Milk Odor StimulationBehavioural
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.
Stimulation of Breast Milk Smell and TasteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Odor stimulation group | Experimental | 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. Receives: Behavioral: Breast Milk Odor Stimulation |
| Odor + Taste Stimulation Group | Experimental | 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. Receives: Behavioral: Stimulation of Breast Milk Smell and Taste |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
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).
Measured: First measurement-First day of hospitalization
Early Feeding Tips Scale
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.
Measured: First measurement-first breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
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.
Measured: First measurement-first breastfeeding of the first day
Early Feeding Tips Scale
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.
Measured: Second measurement-Second breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
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.
Measured: Second measurement-Second breastfeeding of the first day
Early Feeding Tips Scale
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.
Measured: Third measurement-Third breastfeeding of the first day
Breastfeeding Identification and Assessment Scale (LATCH)
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.
Measured: Third measurement-Third breastfeeding of the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Jul 2022
- Primary completion15 Sep 2022
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The stratification and blocking method was used to assign the mothers who would participate in the study to the experimental and control groups, taking into account factors such as normal or cesarean delivery and breastfeeding experience. In order to ensure homogeneity in the groups, mothers were stratified as mode of delivery (Normal-Cesarean) and breastfeeding experience (Present-Non-existent). After the blocks were formed, the groups included in the study were randomly assigned to the strata with the letters A, B and C using the random numbers table obtained in the computer environment (www.random.org). Which letter would be in which group was determined by lot (A=Odor Stimulation, B=Odor+Taste Stimulation, C=Control Group).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Küçükoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341153
- Sponsor's protocol ID
- SelcukUni2542
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
Publications
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.
PubMed 11332925Raimbault 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.
PubMed 17407458Yildiz 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.
PubMed 21884372Thoyre 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.
PubMed 15960007Aykanat 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.
PubMed 35110111Jensen 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.
PubMed 8176525
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastmilk Smelling and Tasting & Smelling First Breastfeeding Practices on Sucking Success and Early Period Feeding Clues of Term Newborns
- ClinicalTrials.gov ID
- NCT06341153
- Acronym / sponsor ID
- SelcukUni2542
- Conditions
- Breastfeeding, Odors, Body, Newborn; Vitality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sibel KüçükoğluUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The stratification and blocking method was used to assign the mothers who would participate in the study to the experimental and control groups, taking into account factors such as normal or cesarean delivery and breastfeeding experience. In order to ensure homogeneity in the groups, mothers were stratified as mode of delivery (Normal-Cesarean) and breastfeeding experience (Present-Non-existent). After the blocks were formed, the groups included in the study were randomly assigned to the strata with the letters A, B and C using the random numbers table obtained in the computer environment (www.random.org). Which letter would be in which group was determined by lot (A=Odor Stimulation, B=Odor+Taste Stimulation, C=Control Group).
| Arm | Type | Receives |
|---|---|---|
| Odor stimulation group | Experimental | Behavioral: Breast Milk Odor StimulationIn 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. |
| Odor + Taste Stimulation Group | Experimental | Behavioral: Stimulation of Breast Milk Smell and TasteIn 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- Under 18 and over 40 years of age,
- Development of postpartum complications (in mother or baby),
- Multiple pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Milk Odor StimulationIn 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. | Behavioural | Odor stimulation group |
| Stimulation of Breast Milk Smell and TasteIn 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. | Behavioural | Odor + Taste Stimulation Group |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 11332925Varendi H, Porter RH. Breast odour as the only maternal stimulus elicits crawling towards the odour source. Acta Paediatr. 2001 Apr;90(4):372-5.
- Background: PubMed 17407458Raimbault 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.
- Background: PubMed 21884372Yildiz 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.
- Background: PubMed 15960007Thoyre 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.
- Background: PubMed 35110111Aykanat 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.
- Background: PubMed 8176525Jensen 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.
- Individual participant dataSharing planned: No. It will be shared after the article is published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Kucukoglu study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Milk Odor Stimulation and Stimulation of Breast Milk Smell and Taste in people with Breastfeeding and Odors, Body, run by Sibel Küçükoğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: First measurement-First day of hospitalization). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341153, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.