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

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.

Study Overview

• Status: Completed
• Conditions: Newborn Jaundice
• Intervention / Treatment: Other: breast milk smell

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Odunpazarı
    • Eskisehir, Odunpazarı, Turkey, 26000
      • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 5 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.; Other Names: kontrol grubu
No Intervention: control group; No intervention was performed during phototherapy treatment in newborns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Upon completion of the study, an average of 3 days

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: phototherapy; newborn; breast milk smell
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: ENilayKizilay

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No