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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190228042868N1

Enrollment

128

Registered

2019-05-25

Start date

2019-04-21

Completion date

Unknown

Last updated

2019-08-26

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

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

Interventions

Intervention 1: In the intervention group, feeding with lactating cells started by separating of the fat and protein layer. these neonate can not tolerate whole breast milk. Intervention 2: Control g

Eligibility

Sex/Gender

All

Age

1 Days to 90 Days

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShafiee Rodsari Mohammad

Shahid Beheshti University of Medical Sciences

leilashsh@yahoo.com+98 21 2292 2827

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 14, 2026