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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06341153
Other study ID # SelcukUni2542
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2022
Est. completion date November 15, 2023

Study information

Verified date March 2024
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date November 15, 2023
Est. primary completion date September 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (2)

Lead Sponsor Collaborator
Sibel Küçükoglu Health Institutes of Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). First measurement-First day of hospitalization
Primary 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. First measurement-first breastfeeding of the first day
Primary 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 Okumus 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
Primary 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. Second measurement-Second breastfeeding of the first day
Primary 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 Okumus 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
Primary 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. Third measurement-Third breastfeeding of the first day
Primary 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 Okumus 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
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