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Clinical Trials/NCT05167474
NCT05167474CompletedNot Applicable

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

Eskisehir Osmangazi University2 sites in 1 country72 target enrollmentStarted: August 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
72
Locations
2
Primary Endpoint
To evaluate the effect of breast milk odor on phototherapy duration during phototherapy treatment.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
2 Days to 5 Days (Child)
Sex
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

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eskisehir Osmangazi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Nilay Kizilay

nurse

Eskisehir Osmangazi University

Study Sites (2)

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