Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv
Primary Purpose
Newborn Jaundice
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
breast milk smell
Sponsored by
About this trial
This is an interventional health services research trial for Newborn Jaundice focused on measuring newborn, phototherapy, breast milk smell
Eligibility Criteria
Inclusion Criteria:
- The term baby (37-39+6 weeks) of the newborn according to the menstruation of the mothers
- Need to have phototherapy treatment for the first time
- Not taking analgesics and/or sedatives in the last 24 hours
- Body weight in the range of 2500 - 4000 g
- Postnatal age of the newborn greater than 48 hours
- Turkish Neonatology Society's approach, follow-up and treatment guideline for neonatal jaundice (2014) Being a medium and high risk baby according to the table of risk status determination of babies according to postnatal age and transcutaneous or total serum bilirubin values.
- Not taking any treatment or medication other than phototherapy treatment
- The mother and/or father accepting the study is having a baby.
Exclusion Criteria:
- Having a health problem other than physiological jaundice
- Findings such as tachypnea, fever
- Having an invasive procedure other than blood sampling once a day for babies
- Exchanged babies
- Babies with Rh and AB0 incompatibility
- Babies with elevated bilirubin levels earlier than 48 hours
- Discord with family
Sites / Locations
- Eskisehir Osmangazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
breast milk smell
control group
Arm Description
The application of maternal education for the phototherapy method for newborns is to place the cotton unloaded by the mother in a container and place it close to the shape.
No intervention was performed during phototherapy treatment in newborns.
Outcomes
Primary Outcome Measures
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.
While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.
To evaluate the bilirubin level of breast milk odor during phototherapy treatment
While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.
Secondary Outcome Measures
Full Information
NCT ID
NCT05167474
First Posted
November 10, 2021
Last Updated
December 9, 2021
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT05167474
Brief Title
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv
Official Title
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
ABSTRACT Purpose: This research was done for the purpose of determining the impact of breast milk smell administered to term infants hospitalized in neonatal intensive care units (NICU) due to physiological jaundice on their bilirubin levels, length of remaining in phototherapy and comfort.
Material and Method: It is an experimental, randomisation, controlled research. Target population of the research consisted of a total of 72 term infants who were hospitalized in the NICU of Bilecik Bozuyuk Public Hospital and met the sample selection criteria. Our research includes two groups. Breast milk smell group and control group. The infants were assigned to the groups via randomization method. Sample assignment to the groups was performed using stratification and blocking methods. The infants meeting the research sample selection criteria were stratified according to their postnatal age and then assigned to each group equally (blocking) by lot. However, two infants in the control group were excluded from the research at the request of their parents as the research continued. Thus, the research was completed with a total of 72 infants; 37 in the breast milk smell group and 35 in the control group. In the research, the data were collected using "Personal Data Collection Form", "Phototherapy Follow-up Chart" and "Neonatal Comfort Behavior Scale". The data were analyzed using the SPSS (Statistical Package for Social Sciences) 21.0 (IBM corp. Relased 2012. IBM SPSS Statistics for Windows, version 21.0 Armonk, NY: IBM corp.) package software.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Jaundice
Keywords
newborn, phototherapy, breast milk smell
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
breast milk smell
Arm Type
Active Comparator
Arm Description
The application of maternal education for the phototherapy method for newborns is to place the cotton unloaded by the mother in a container and place it close to the shape.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention was performed during phototherapy treatment in newborns.
Intervention Type
Other
Intervention Name(s)
breast milk smell
Other Intervention Name(s)
kontrol grubu
Intervention Description
yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.
Primary Outcome Measure Information:
Title
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.
Description
While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.
Time Frame
Upon completion of the study, an average of 3 days
Title
To evaluate the bilirubin level of breast milk odor during phototherapy treatment
Description
While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.
Time Frame
Upon completion of the study, an average of 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The term baby (37-39+6 weeks) of the newborn according to the menstruation of the mothers
Need to have phototherapy treatment for the first time
Not taking analgesics and/or sedatives in the last 24 hours
Body weight in the range of 2500 - 4000 g
Postnatal age of the newborn greater than 48 hours
Turkish Neonatology Society's approach, follow-up and treatment guideline for neonatal jaundice (2014) Being a medium and high risk baby according to the table of risk status determination of babies according to postnatal age and transcutaneous or total serum bilirubin values.
Not taking any treatment or medication other than phototherapy treatment
The mother and/or father accepting the study is having a baby.
Exclusion Criteria:
Having a health problem other than physiological jaundice
Findings such as tachypnea, fever
Having an invasive procedure other than blood sampling once a day for babies
Exchanged babies
Babies with Rh and AB0 incompatibility
Babies with elevated bilirubin levels earlier than 48 hours
Discord with family
Facility Information:
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
State/Province
Odunpazarı
ZIP/Postal Code
26000
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv
We'll reach out to this number within 24 hrs