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Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants

Effect of early administration of oropharyngeal colostrum on immune status and common morbidities of premature infants with gestational age Less or equal 30 weeks and birth body weight Less or equal 1500 gram

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171230038142N19
Enrollment
60
Registered
2020-08-16
Start date
2020-03-05
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Premature Infants. Preterm premature rupture of membranes, onset of labor within 24 hours of rupture, unspecified trimester

Interventions

Intervention 1: Intervention group: For infants in this group, a syringe containing colostrum taken from the milk of infants' own mothers (0.2 ml) is oropharyngeally administered on the left and right

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Infants less than or equal to 30 weeks old and weighing less than or equal to 1500 g Absence of major congenital malformations Apgar higher than 4 in the fifth minute of birth

Exclusion criteria

Exclusion criteria: Unable to provide colostrum by the mother, to the extent required for study Diagnosis of early sepsis with positive blood culture Urinary Tract Infection Need to continue receiving aminoglycoside after the first 96 hours of birth Maternal HIV infection History of maternal chorio amnionitis

Design outcomes

Primary

MeasureTime frame
Urinary IgA Concentration. Timepoint: Before the intervention, eighth day of birth, 15th day of birth. Method of measurement: Measurement of IgA concentration in urine samples using Turbidometry method.;The prevalence of necrotizing enterocolitis. Timepoint: During hospitalization. Method of measurement: Counting cases.;The prevalence of mortality. Timepoint: During hospitalization. Method of measurement: death count.;Duration of complete intestinal nutrition. Timepoint: During hospitalization. Method of measurement: Counting the days.;Duration of hospitalization. Timepoint: Duration of hospitalization. Method of measurement: Counting the days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Jafari

Esfahan University of Medical Sciences

jafari@pharm.mui.ac.ir+98 31 3668 0048

Outcome results

None listed

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