Clinical trial NCT06341153: The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips
Official title: The Effect of Breastmilk Smelling and Tasting & Smelling First Breastfeeding Practices on Sucking Success and Early Period Feeding Clues of Term Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Odors, Body
Newborn; Vitality
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2024-04-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Introductory Information Form
timeFrame: First measurement-First day of hospitalization
measure: Early Feeding Tips Scale
timeFrame: First measurement-first breastfeeding of the first day
measure: Breastfeeding Identification and Assessment Scale (LATCH)
timeFrame: First measurement-first breastfeeding of the first day
measure: Early Feeding Tips Scale
timeFrame: Second measurement-Second breastfeeding of the first day
measure: Breastfeeding Identification and Assessment Scale (LATCH)
timeFrame: Second measurement-Second breastfeeding of the first day
measure: Early Feeding Tips Scale
timeFrame: Third measurement-Third breastfeeding of the first day
measure: Breastfeeding Identification and Assessment Scale (LATCH)
timeFrame: Third measurement-Third breastfeeding of the first day
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
citation: 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.
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.