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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
48
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.
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.
Seoul National University Children's Hospital
Seoul, South Korea
Urinary Secretary IgA Concentration at 2 Weeks of Age
Time frame: 2 weeks of age
Urinary Secretary IgA Concentration at 1 Week of Age
Time frame: 1 week of age
Salivary TGF-beta 1 Concentration at 2 Week of Age
Time frame: 2 week of age
Salivary IL-8 Concentration at 2 Weeks of Age
Time frame: 2 weeks of age
Concentration of Urinary Lactoferrin
Time frame: 1 week of age
Concentration of Urinary IL-1 Beta
Time frame: 2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Time frame: 1 week of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines
Time frame: 2 weeks of age
Time to Reach Full Feeding
day of life when the baby reaches full enteral feeding, defined as a volume above 120\~130mL/kg/day
Time frame: up to 2 months of age
Total Hospital Admission Duration
days from admission to discharge from NICU
Time frame: up to 4 months of age
Episodes of Culture Positive Sepsis
numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)
Time frame: from date of randomization up to 4 months of age
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2
Time frame: from date of randomization up to 4 months of age
Episodes of Pneumonia
numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
Time frame: from date of randomization up to 4 months of age
Development of Bronchopulmonary Dysplasia ≥ Moderate
Time frame: up to 4 months of age
Development of Intraventricular Hemorrhage ≥ Grade 3
Time frame: up to 4 months of age
In-hospital Death
Time frame: up to 4 months of age
Development of Adverse Effects
category of adverse effects 1. general - fever or hypothermia, rash 2. respiratory \& cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia 3. gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis 4. renal - oliguria (urine output \< 1.0cc/kg/day) 5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia
Time frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age
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