Clinical trial NCT01536093: Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extremely Low Gestational Age Newborn
Premature Infant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 48
Sex: ALL
Minimum age (years): 48
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Urinary Secretary IgA Concentration at 2 Weeks of Age
timeFrame: 2 weeks of age
Secondary outcomes:
measure: Urinary Secretary IgA Concentration at 1 Week of Age
timeFrame: 1 week of age
measure: Salivary TGF-beta 1 Concentration at 2 Week of Age
timeFrame: 2 week of age
measure: Salivary IL-8 Concentration at 2 Weeks of Age
timeFrame: 2 weeks of age
measure: Concentration of Urinary Lactoferrin
timeFrame: 1 week of age
measure: Concentration of Urinary IL-1 Beta
timeFrame: 2 weeks of age
measure: Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
timeFrame: 1 week of age
measure: Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
timeFrame: 2 weeks of age
measure: Time to Reach Full Feeding
timeFrame: up to 2 months of age
measure: Total Hospital Admission Duration
timeFrame: up to 4 months of age
measure: Episodes of Culture Positive Sepsis
timeFrame: from date of randomization up to 4 months of age
measure: Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
timeFrame: from date of randomization up to 4 months of age
measure: Episodes of Pneumonia
timeFrame: from date of randomization up to 4 months of age
measure: Development of Bronchopulmonary Dysplasia ≥ Moderate
timeFrame: up to 4 months of age
measure: Development of Intraventricular Hemorrhage ≥ Grade 3
timeFrame: up to 4 months of age
measure: In-hospital Death
timeFrame: up to 4 months of age
measure: Development of Adverse Effects
timeFrame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References:
citation: Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.