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Evaluating the effect of oropharyngeal colostrum in very low birth weight premature infant.

Evaluating the effect of oropharyngeal colostrum administration from the first day of life in very low birth weight premature infant

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141118019991N2
Enrollment
50
Registered
2019-10-16
Start date
2019-11-21
Completion date
Unknown
Last updated
2019-11-05

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

Conditions

Condition 1: Sepsis. Condition 2: Narcotizing Enterocolitis. Condition 3: Mortality. Condition 4: Hospitalization Duration. Condition 5: Full Fed time. Sepsis, unspecified organism Necrotizing enterocolitis in newborn, unspecified Ill-defined and unknown cause of mortality

Interventions

Intervention 1: Intervention group: Oropharyngeal administration of 0.2 cc Colostrum was started at the first hour of life, It was given every 3 hour for 3 days. Intervention 2: Control group: Breast

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Birth Weight lower than 1500 grams Gestational Age lower than 32 weeks Infant without congenital abnormalities. No evidence of asphyxia.

Exclusion criteria

Exclusion criteria: Birth Weight more than 1500 grams. Gestational Age more than 32 weeks. Infant with congenital abnormalities. Infant with asphyxia. Need for resuscitation after birth. Drug Abuser mother. Mother who has HIV positive test. Mothers who are Cytomegal Virus seropositive

Design outcomes

Primary

MeasureTime frame
Sepsis Early or Late Onset, clinical or Para-clinical Sign and Symptoms. Timepoint: Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation. Method of measurement: Clinical and Para-clinical Signs and Symptoms.;Clinical and Para-clinical sign of Necrotizing Enterocolitis. Timepoint: Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation. Method of measurement: Clinical and Para-clinical Signs and symptoms.;Hospitalization Duration. Timepoint: Hospitalization Duration by days number at discharge. Method of measurement: Hospitalization Duration.

Secondary

MeasureTime frame
Mortality. Timepoint: the time of Dead. Method of measurement: Vital sign not recorded and no respond to Resuscitation.;Weight gain progress. Timepoint: Daily. Method of measurement: SEGA digital scale.;The time to reach full enteral feeding (120 cc / kg). Timepoint: Daily. Method of measurement: It was calculated every day by the neonatologist and Neonate feeding tolerance .

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaharnaz Talebiyan

Shahid Beheshti University of Medical Sciences

s_talebiyan@yahoo.com+98 21 2271 3333

Outcome results

None listed

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