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

Phase 2

Recruiting

• Conditions: Premature Infants.; Preterm premature rupture of membranes, onset of labor within 24 hours of rupture, unspecified trimester; O42.019

• Registration Number: IRCT20171230038142N19
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rinary 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.