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Effects of breast milk, chlorhexidine, and drying on bacterial infection in umbilical cord

A clinical trial comparing the local effects of breast milk, chlorhexidine, and drying on bacterial colonization in umbilical cord of preterm neonates hospitalized in the neonatal intensive care unit

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017090517756N27
Enrollment
75
Registered
2017-10-16
Start date
2017-06-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Bacterial colonization. Bacterial infection, unspecified

Interventions

Intervention 1: Intervention Group 1 (Drying): During the first 12 to 24 hours of admission, umbilical cord samples will be collected from the neonates using a sterile swab. In this group, the umbilic
Prevention
Intervention Group 1 (Drying): During the first 12 to 24 hours of admission, umbilical cord samples will be collected from the neonates using a sterile swab. In this group, the umbilical cord will be
Intervention Group 2 (Chlorhexidine): During the first 12 to 24 hours of admission, umbilical cord samples will be collected from the neonates using a sterile swab. In this group, every six hours, 2 t
Intervention Group 3 (Mother's breast milk): During the first 12 to 24 hours of admission, umbilical cord samples will be collected from the neonates using a sterile swab. In this group, every six hou

Sponsors

Vice-Chancellery for Research and Technology, Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Gestational age less than 37 weeks ; need for admission in the neonatal intensive care unit; treatment with ampicillin and gentamicin antibiotics. Exclusion criteria: Dissatisfaction of the legal guardian(s) for participation; confirmed sepsis before bacterial culture; history of non-sterile childbirth; presence of anatomical malformation;history of perinatal asphyxia; presence of symptoms of omphalitis before the test; history of infections in the mother during pregnancy; prescribed antibiotics in the mother before delivery; prolonged rupture of fetal membranes; umbilical catheterization; any umbilical intervention during hospitalization; chorioamononitis

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Density of bacteria. Timepoint: Before and 72 hours after the intervention initiates. Method of measurement: Laboratory tests in terms of colony-forming unit per square centimeter.;Species of bacteria. Timepoint: Before and 72 hours after the intervention initiates. Method of measurement: Laboratory tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mozhgan Yaghoobi

Birjand University of Medical Sciences

mzyaghoobi@yahoo.com+98 56 3162 2218

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 21, 2026