NCT06341153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 15, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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.

    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.

    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.

    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.

    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.

    Third measurement-Third breastfeeding of the first day

Study Arms (3)

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.

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.

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.

Interventions

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.

Odor 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.

Odor + Taste Stimulation Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreastfeeding mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 11332925BACKGROUND
  • 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.

    PMID: 17407458BACKGROUND
  • 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.

    PMID: 21884372BACKGROUND
  • 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.

    PMID: 15960007BACKGROUND
  • 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.

    PMID: 35110111BACKGROUND
  • 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.

    PMID: 8176525BACKGROUND

MeSH Terms

Conditions

Breast FeedingBody Odor

Interventions

Taste

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sibel Kucukoglu

    Selcuk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
According to the a priori power analysis with a pairwise hypothesis, effect size of 0.409, significance level of 0.05 and power of 0.80; it was determined that the inclusion of a total of 72 newborns (Odor Stimulation: 24, Odor+taste stimulation: 24, Control: 24) in the study would provide sufficient sample size. 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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Responsible researcher (Prof)

Study Record Dates

First Submitted

March 15, 2024

First Posted

April 2, 2024

Study Start

July 15, 2022

Primary Completion

September 15, 2022

Study Completion

November 15, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

It will be shared after the article is published

Locations