The effect of cholesterom mouthwash on oral care and prevention of late-onset sepsis

The effect of cholesterom mouthwash on oral care level and the incidence of late-onset Sepsis in premature hospitalized infants: randomized controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200818048448N1

Enrollment

Registered

2020-12-13

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Oral care of preterm infant. Condition 2: sepsis. Encounter for health supervision and care of other healthy infant and child Bacterial sepsis of newborn

Interventions

Intervention 1: Intervention group: in the intervention group, colostrum will be used for mouthwash. For this purpose, in each oral care (every 4 to 6 hours), an amount of 0.2 to 0.3 cc of each mother

Eligibility

Sex/Gender

All

Age

1 Days to 5 Days

Inclusion criteria

Inclusion criteria: Premature infants between 28 and 32 weeks of pregnancy Being hospitalized in level one and two neonatal intensive care units for to 5 days Access to the mother's colostrum No abnormalities in the infant's mouth and throat The mother does not have active viral infections during pregnancy and delivery Infants under nasal cpap Being NPO

Exclusion criteria

Exclusion criteria: Neonatal asphyxia (umbilical cord pH <0.7) Disorders during infant birth Chromosomal abnormalities Development of early neonatal sepsis Unstability of the infant's physiological condition more than twice before the intervention (decreased O2 saturation, bradycardia, etc.) Receiving mechanical ventilation Using of certain medicene by the mother, which is prohibited during breastfeeding

Design outcomes

Primary

Measure	Time frame
Oral care level. Timepoint: At the end of each day of the intervention (for 5 days). Method of measurement: To assess the level of oral care of the infant, the "Oral Assessment Tool for Neonates" will be used, in which the infant's mouth is examined in four parts of the lips and corners of the mouth, tongue, saliva and mucous membranes. The status of each section is scored from 1 to 3. Therefore, the level of need for oral care will be between zero and 12, and as the score increases, the level of oral care for the infant will also increase.;Late-onset sepsis. Timepoint: 72 hours after birth. Method of measurement: The initial diagnosis of sepsis is based on clinical symptoms (fever, poor feeding, respiratory distress, hypotension, decreased reflexes, etc.) and if symptoms are present, it will be confirmed by laboratory CBC values and positive CRP and blood culture.	—

Measure

Time frame

Oral care level. Timepoint: At the end of each day of the intervention (for 5 days). Method of measurement: To assess the level of oral care of the infant, the "Oral Assessment Tool for Neonates" will be used, in which the infant's mouth is examined in four parts of the lips and corners of the mouth, tongue, saliva and mucous membranes. The status of each section is scored from 1 to 3. Therefore, the level of need for oral care will be between zero and 12, and as the score increases, the level of oral care for the infant will also increase.;Late-onset sepsis. Timepoint: 72 hours after birth. Method of measurement: The initial diagnosis of sepsis is based on clinical symptoms (fever, poor feeding, respiratory distress, hypotension, decreased reflexes, etc.) and if symptoms are present, it will be confirmed by laboratory CBC values and positive CRP and blood culture.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahni Rahkar Farshi

Tabriz University of Medical Sciences

rahkarfarshim@tbzmed.ac.ir+98 41 3477 0648

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026