Evaluation of enteral administration of fat in very low birth weight infants

comparison of intravenous v/s enteral administration of fat emulsion in very low birth weight infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201310164113N5

Enrollment

Registered

2015-08-01

Start date

2015-06-26

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

prematurity. Less than 28 completed weeks (less than 196 completed days) of gestation.

Interventions

Intervention 1: In intervention group after tolerating the Minimal enteral feeding of breast milk we will start fat emulsion (Esmof20%) enteraly. Dose of Fat will be 1 gr/kg/d and will be increased s

Treatment - Drugs

In intervention group after tolerating the Minimal enteral feeding of breast milk we will start fat emulsion (Esmof20%) enteraly. Dose of Fat will be 1 gr/kg/d and will be increased step by step to 3

In control group Fat emulsion will be given by intravenous rout. Dose of Fat will be 1 gr/kg/d and will be increased step by step to 3 gr/kg/d.

Eligibility

Sex/Gender

All

Age

3 Days to 3 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Inborn Very Low Birth Weight infants in Alzahra Teaching Hospital; Birth Weight between 700-1499 gram; Appropriate for Gestational Age; without proven sepsis Exclusion Criteria : first blood culture positive( during 48 hours); Major congenital Anomalies; Nercotizing Entrocolitis; Direct Hyperbilirubinemia( Direct Bilirubin more than 2 Mg/dl and more than 15% of total Bilirubin ); Sever heart failure need treatment or Shock

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Daily weight gain. Timepoint: From 3-5 days until3 weeks. Method of measurement: A digital scale with 1 gr sensivity.;Frequency of Necrotizing enterocolitis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Aspirate more than 30% of previus feeding and the circomference of the belly more than 2 Cm with raidiologic findding.;Mortality rate. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: evaluation of heart rate and respiration.;Head circomference. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: use of plastic tape with 1 CM accuracy.	—

Measure

Time frame

Daily weight gain. Timepoint: From 3-5 days until3 weeks. Method of measurement: A digital scale with 1 gr sensivity.;Frequency of Necrotizing enterocolitis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Aspirate more than 30% of previus feeding and the circomference of the belly more than 2 Cm with raidiologic findding.;Mortality rate. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: evaluation of heart rate and respiration.;Head circomference. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: use of plastic tape with 1 CM accuracy.

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Secondary

Measure	Time frame
Frequency of proven sepsis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Evaluation of clinical sign and CBC and CRP and Blood Culture.;Mean of serum triglycerid. Timepoint: From 3-5 days until 3 weeks. Method of measurement: mesuring serum triglycerid level by Selectra machin.;Frequency of feeding intolerance. Timepoint: From 3-5 days until 3 weeks. Method of measurement: Evaluation of GI aspitate before each feeding and finding more than 30% of previus one.;Frequency of Chronic Lung Disease. Timepoint: From 28 days until discharge from hospital. Method of measurement: Need of Oxygen or ventilatoey support.;Frequency of Retinopathy Of Prematurity. Timepoint: From 28 days until discharge from hospital. Method of measurement: Examination of the retin by indirect Retinoscopy.;Mean of hospitalization. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: hospitalization recording sheet.;Frequency of Cholestasis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Evaluation of Direct and Indirect Bilirubin level by Selectra Machin.	—

Measure

Time frame

Frequency of proven sepsis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Evaluation of clinical sign and CBC and CRP and Blood Culture.;Mean of serum triglycerid. Timepoint: From 3-5 days until 3 weeks. Method of measurement: mesuring serum triglycerid level by Selectra machin.;Frequency of feeding intolerance. Timepoint: From 3-5 days until 3 weeks. Method of measurement: Evaluation of GI aspitate before each feeding and finding more than 30% of previus one.;Frequency of Chronic Lung Disease. Timepoint: From 28 days until discharge from hospital. Method of measurement: Need of Oxygen or ventilatoey support.;Frequency of Retinopathy Of Prematurity. Timepoint: From 28 days until discharge from hospital. Method of measurement: Examination of the retin by indirect Retinoscopy.;Mean of hospitalization. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: hospitalization recording sheet.;Frequency of Cholestasis. Timepoint: From 3-5 days until discharge from hospital. Method of measurement: Evaluation of Direct and Indirect Bilirubin level by Selectra Machin.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Bagher Hosseini

Tabriz University of Medical Sceinces

hossainm@tzmed.ac.ir+98 41 3553 9161

Outcome results

None listed

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