Newborn JaundiceNCT05167474
Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv
A study testing breast milk smell in people with Newborn Jaundice, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn Jaundice
- What is being tested?
- breast milk smell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 10 Apr 2019
- 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 2 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26000
About this study
Official title: Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapy
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.
- Conditions
- Newborn Jaundice
- Being tested
- breast milk smell
- Keywords
- newborn, phototherapy, breast milk smell
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milk smellOther
Also called kontrol grubu
yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.
| Study group | Role | What they receive |
|---|---|---|
| breast milk smell | Active comparator | 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. Receives: Other: breast milk smell |
| control group | No intervention | No intervention was performed during phototherapy treatment in newborns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon completion of the study, an average of 3 days
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.
Measured: Upon completion of the study, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Aug 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn JaundiceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Nilay Kizilay, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167474
- Sponsor's protocol ID
- ENilayKizilay
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT05167474
- Acronym / sponsor ID
- ENilayKizilay
- Conditions
- Newborn Jaundice
- Keywords
- newborn, phototherapy, breast milk smell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 22 Dec 2021 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast milk smell | Active comparator | Other: breast milk smellThe 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. |
| control group | No intervention | –No intervention was performed during phototherapy treatment in newborns. |
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 smellAlso: kontrol grubuyenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır. | Other | breast milk smell |
Primary outcome
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.
Time frame: Upon completion of the study, an average of 3 days
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
Time frame: Upon completion of the study, an average of 3 days
While newborns received phototherapy treatment, cotton wool moistened with breast milk in a container was placed near the newborn's nose.
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 22 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 smell in people with Newborn Jaundice, run by Eskisehir Osmangazi University 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 7 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 22 Dec 2021. 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?
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment. (time frame: Upon completion of the study, an average of 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2021.