Investigating the effect of Oropharyngeal colostrum in the prevention of late-onset sepsis in preterm infants admitted to neonatal intensive care unit by extraoral massage method

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230312057698N1

Enrollment

Registered

2023-03-29

Start date

2023-04-09

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

late-onset sepsis. Bacterial sepsis of newborn

Interventions

Intervention 1: Intervention group: In the intervention group, 0.4 ml (4 units) of mother's colostrum was drawn into a 1 ml syringe (insulin syringe) and 0.2 ml (2 units) on each side of the mouth on

Eligibility

Sex/Gender

All

Age

1 Days to 2 Days

Inclusion criteria

Inclusion criteria: Premature infants with a gestational age between 28 and 32 Premature infants without congenital abnormalities (digestive disorders) or genetic syndromes Premature infants without mechanical ventilation infant being NPO Not having early sepsis or not having early sepsis risk factors The mother's absence of active viral infections during pregnancy and childbirth

Exclusion criteria

Exclusion criteria: The infant's condition is not stable during the intervention more than twice (loss of saturation, bradycardia,...) Parents withdraw from continuing the research project or infants die before 7 days infants need urgent surgery

Design outcomes

Primary

Measure	Time frame
Late-onset sepsis. Timepoint: 72 hours after birth. Method of measurement: In order to distinguish clinical sepsis from other differential diagnoses in the intensive care unit of newborns, two factors CRP (C-reactive protein) and PCT (procalcitonin) are checked for suspected babies.Clinical sepsis by examining 6 criteria that include general appearance symptoms (temperature instability, paleness, skin reticulation or motilization, jaundice, bruising, petechiae) and nervous system symptoms (lethargy or irritability, hypertonia or hypotonia, loud crying) loud, trembling, restlessness) and symptoms of the cardiovascular system (tachycardia or bradycardia, hypotension, cyanosis) and symptoms of the respiratory system (apnea or tachypnea, decrease in blood oxygen saturation, hearing the sound of a baby moaning or grunting, drawn in chest muscles or retraction) and digestive system symptoms (abdominal distention, vomiting, food intolerance, diarrhea) and urinary reproductive system symptoms (decrease in urinary output or oliguria)] are determined.	—

Measure

Time frame

Late-onset sepsis. Timepoint: 72 hours after birth. Method of measurement: In order to distinguish clinical sepsis from other differential diagnoses in the intensive care unit of newborns, two factors CRP (C-reactive protein) and PCT (procalcitonin) are checked for suspected babies.Clinical sepsis by examining 6 criteria that include general appearance symptoms (temperature instability, paleness, skin reticulation or motilization, jaundice, bruising, petechiae) and nervous system symptoms (lethargy or irritability, hypertonia or hypotonia, loud crying) loud, trembling, restlessness) and symptoms of the cardiovascular system (tachycardia or bradycardia, hypotension, cyanosis) and symptoms of the respiratory system (apnea or tachypnea, decrease in blood oxygen saturation, hearing the sound of a baby moaning or grunting, drawn in chest muscles or retraction) and digestive system symptoms (abdominal distention, vomiting, food intolerance, diarrhea) and urinary reproductive system symptoms (decrease in urinary output or oliguria)] are determined.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda behroj

Babol University of Medical Sciences

nedabehroj63@gmail.com+98 11 3474 1827

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026