Skip to main content
OpenTrials
Completed

NCT Number: NCT05167474

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Newborn Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Milk Smell

Other

yenidoğanlara fototerapi tedavisi esnasında anne sütü kokusu uygulanmıştır.

Other names: kontrol grubu

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2021
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.