Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.

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Detailed Description

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Conditions

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Extremely Low Gestational Age Newborn Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Colostrum

oropharyngeal administration of own mother's colostrum

Group Type EXPERIMENTAL

oropharyngeal administration of own mother's colostrum

Intervention Type OTHER

application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Placebo

oropharyngeal administration of sterile water

Group Type PLACEBO_COMPARATOR

oropharyngeal administration of sterile water

Intervention Type OTHER

application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Interventions

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oropharyngeal administration of own mother's colostrum

application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Intervention Type OTHER

oropharyngeal administration of sterile water

application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
* parents of the infant signed to the informed consent form with voluntary agreement

Exclusion Criteria

* infants with major congenital anomalies or chromosomal syndromes
* infants of mothers not willing to provide colostrum in the first week of life
* infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB

Minimum Eligible Age

48 Hours

Maximum Eligible Age

96 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes