Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01536093
First received: January 6, 2012
Last updated: August 11, 2014
Last verified: August 2014

January 6, 2012
August 11, 2014
January 2012
December 2013   (final data collection date for primary outcome measure)
Urinary Secretary IgA Concentration at 2 Weeks of Age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
Change in Urinary Secretary IgA Concentration From Baseline to 2 Weeks of Age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01536093 on ClinicalTrials.gov Archive Site
  • Urinary Secretary IgA Concentration at 1 Week of Age [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • Salivary TGF-beta 1 Concentration at 2 Week of Age [ Time Frame: 2 week of age ] [ Designated as safety issue: No ]
  • Salivary IL-8 Concentration at 2 Weeks of Age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • Concentration of Urinary Lactoferrin [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • Concentration of Urinary IL-1 Beta [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • Time to Reach Full Feeding [ Time Frame: up to 2 months of age ] [ Designated as safety issue: No ]
    day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day
  • Total Hospital Admission Duration [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
    days from admission to discharge from NICU
  • Episodes of Culture Positive Sepsis [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
    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)
  • Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2 [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
  • Episodes of Pneumonia [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
    numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
  • Development of Bronchopulmonary Dysplasia ≥ Moderate [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • Development of Intraventricular Hemorrhage ≥ Grade 3 [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • In-hospital Death [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • Development of Adverse Effects [ Time Frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age ] [ Designated as safety issue: Yes ]

    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
  • change in urinary secretary IgA concentration from baseline to 1 week of age [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • change in salivary secretary IgA concentration from baseline to 1 week of age [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • change in salivary secretary IgA concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • concentration of urinary lactoferrin, lysozyme, alpha-lactalbumin and cytokines [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • concentration of urinary lactoferrin, lysozyme, alpha-lactalbumin and cytokines [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • concentration of salivary lactoferrin, lysozyme, alpha-lactalbumin and cytokines [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • concentration of salivary lactoferrin, lysozyme, alpha-lactalbumin and cytokines [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • time to reach full feeding [ Time Frame: up to 2 months of age ] [ Designated as safety issue: No ]
    day of life when the baby reachs full enteral feeding, defined as a volume above 120~130mL/kg/day
  • total hospital admission duration [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
    days from admission to discharge from NICU
  • episodes of culture positive sepsis [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
    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)
  • episodes of necrotizing enterocolitis ≥ Bell's stage 2 [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
  • episodes of pneumonia [ Time Frame: from date of randomization up to 4 months of age ] [ Designated as safety issue: No ]
    numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics
  • development of bronchopulmonary dysplasia ≥ moderate [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • development of intraventricular hemorrhage ≥ grade 3 [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • in-hospital death [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
  • development of adverse effects [ Time Frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age ] [ Designated as safety issue: Yes ]

    category of adverse effects

    1. general - fever or hypothermia, rash
    2. respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia
    3. gastrointestinal - abdominal distension, bilous gastric remain, vomiting, bloody stool, necrotizing enterocolitis
    4. renal - oliguria (urine output < 1.0cc/kg/day)
    5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia
Not Provided
Not Provided
 
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Extremely Low Gestational Age Newborn
  • Premature Infant
  • Other: 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.
  • 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.
  • Experimental: Colostrum
    oropharyngeal administration of own mother's colostrum
    Intervention: Other: oropharyngeal administration of own mother's colostrum
  • Placebo Comparator: Placebo
    oropharyngeal administration of sterile water
    Intervention: Other: oropharyngeal administration of sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 96 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01536093
OAC-01-ELGAN
Yes
Han-Suk Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP