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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colostrum | Experimental | oropharyngeal administration of own mother's colostrum |
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| Placebo | Placebo Comparator | oropharyngeal administration of sterile water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oropharyngeal administration of own mother's colostrum | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Secretary IgA Concentration at 2 Weeks of Age | 2 weeks of age |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Secretary IgA Concentration at 1 Week of Age | 1 week of age | |
| Salivary TGF-beta 1 Concentration at 2 Week of Age | 2 week of age | |
| Salivary IL-8 Concentration at 2 Weeks of Age |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25624376 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Colostrum | oropharyngeal administration of own mother's colostrum 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| oropharyngeal administration of sterile water | 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. |
|
| 2 weeks of age |
| Concentration of Urinary Lactoferrin | 1 week of age |
| Concentration of Urinary IL-1 Beta | 2 weeks of age |
| Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines | 1 week of age |
| Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines | 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 | up to 2 months of age |
| Total Hospital Admission Duration | days from admission to discharge from NICU | 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) | from date of randomization up to 4 months of age |
| Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2 | 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 | from date of randomization up to 4 months of age |
| Development of Bronchopulmonary Dysplasia ≥ Moderate | up to 4 months of age |
| Development of Intraventricular Hemorrhage ≥ Grade 3 | up to 4 months of age |
| In-hospital Death | up to 4 months of age |
| Development of Adverse Effects | category of adverse effects
| from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age |
oropharyngeal administration of sterile water 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Colostrum | oropharyngeal administration of own mother's colostrum 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. |
| BG001 | Placebo | oropharyngeal administration of sterile water 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational Age | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Birth weight | Mean | Standard Deviation | g |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Urinary Secretary IgA Concentration at 2 Weeks of Age | Posted | Mean | Standard Deviation | ng per g creatinine | 2 weeks of age |
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| Secondary | Urinary Secretary IgA Concentration at 1 Week of Age | Posted | Mean | Standard Deviation | ng per g creatinine | 1 week of age |
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| Secondary | Salivary TGF-beta 1 Concentration at 2 Week of Age | Posted | Mean | Standard Deviation | ug/mL | 2 week of age |
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| Secondary | Salivary IL-8 Concentration at 2 Weeks of Age | Posted | Mean | Standard Deviation | ng/mL | 2 weeks of age |
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| Secondary | Concentration of Urinary Lactoferrin | Posted | Mean | Standard Deviation | ug per g creatinine | 1 week of age |
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| Secondary | Concentration of Urinary IL-1 Beta | Posted | Mean | Standard Deviation | ug per g creatinine | 2 weeks of age |
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| Secondary | Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines | Not Posted | 1 week of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines | Not Posted | 2 weeks of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Full Feeding | day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day | Not Posted | up to 2 months of age | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Hospital Admission Duration | days from admission to discharge from NICU | Not Posted | up to 4 months of age | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | Not Posted | from date of randomization up to 4 months of age | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2 | Not Posted | from date of randomization up to 4 months of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Episodes of Pneumonia | numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics | Not Posted | from date of randomization up to 4 months of age | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Development of Bronchopulmonary Dysplasia ≥ Moderate | Not Posted | up to 4 months of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Development of Intraventricular Hemorrhage ≥ Grade 3 | Not Posted | up to 4 months of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | In-hospital Death | Not Posted | up to 4 months of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Development of Adverse Effects | category of adverse effects
| Not Posted | from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colostrum | oropharyngeal administration of own mother's colostrum 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. | 0 | 21 | 0 | 21 | ||
| EG001 | Placebo | oropharyngeal administration of sterile water 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. | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juyoung Lee | Seoul National University College of Medicine | 82-31-787-7301 | lamb4122@snu.ac.kr |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Male |
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