Investigating Prognosis of Early Feeding with Breast milk-Cells in Premature infants

Phase 2

Recruiting

• Conditions: Condition 1: Necrotizing enterocolitis (NEC). Condition 2: Bacterial sepsis of newborn. Condition 3: Retinopathy of prematurity. Condition 4: Bronchopulmonary dysplasia.; Necrotizing enterocolitis of newborn; Bacterial sepsis of newborn; Retinopathy of prematurity; Bronchopulmonary dysplasia originating in the perinatal period; H35.1; P27.1

• Registration Number: IRCT20190228042868N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

All the neonates that were born with a birth weight less than 1800 grams

Exclusion Criteria

Parental dissatisfaction with the implementation of this study
Failure to prepare breast milk for various reasons
Congenital severe anomalies
The presence of any serious and fatal illness that is in conflict with life
Severe Prematurity (less than 25 weeks)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of hospital stay. Timepoint: The whole period of admission is evaluated. Method of measurement: Based on observation and examination and questionnaire records.;2-Comparison of the total feeding time in the newborn. Timepoint: From birth to full feeding. Method of measurement: Evidence available in the clinical file and based on the day.;Incidence of necrotizing enterocolitis. Timepoint: The disease occurs most of the time with the onset of nutrition and during the hospital stay. Method of measurement: According to the Bell's criteria.;Time required for the respirator. Timepoint: Duration of treatment with respirator. Method of measurement: Evidence available in the clinical file and based on the day.;Prevalence of retinopathy of prematurity. Timepoint: Ophthalmologic examination for all newborns will be done in about 1 month of age. Method of measurement: It will be calcified according the extent of the vessels of the bottom of the eye.