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CompletedNCT05167474Updated Dec 22, 2021

Influence of Breast Milk Smell on Newborns Bilirubin Level, Duration of Time Phototherapy and Comfort in Newborns Receiving Phototherapyv

An interventional study of breast milk smell in Newborn Jaundice, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey. Open to participants aged 2 Days to 5 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-22.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2018, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
2 Days to 5 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Newborn Jaundice

Keywords

  • newborn
  • phototherapy
  • breast milk smell
03

In context

Jaundice, Neonatal

105 studies on the registry are indexed under Jaundice, Neonatal; 27 are open to participants now.

This study's enrollment of 72 is below the median of 134 across 74 interventional studies indexed under Jaundice, Neonatal.

Browse Jaundice, Neonatal studies →

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 5 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    breast milk smell

    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.

    Other: breast milk smell

  • No intervention
    control group

    No intervention was performed during phototherapy treatment in newborns.

Interventions

  • Otherbreast milk smell

    yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.

    Also known as: kontrol grubu

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Upon completion of the study, an average of 3 days

  2. 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.

    Time frame: Upon completion of the study, an average of 3 days

07

Study locations

1 site
  • Eskisehir Osmangazi University
    Eskisehir, Odunpazarı 26000, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05167474
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Elif Nilay Kizilay (nurse, Eskisehir Osmangazi University) — Principal investigator
First posted
Dec 22, 2021
Start date
Aug 1, 2018
Primary completion
Apr 10, 2019
Completion
Apr 10, 2019
Last update
Dec 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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