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Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

This study is currently recruiting participants.
Verified January 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01536093
First received: January 6, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Extremely Low Gestational Age Newborn
Premature Infant
 Other: oropharyngeal administration of own mother's colostrum
Other: oropharyngeal administration of sterile water
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change in urinary secretary IgA concentration from baseline to 2 weeks of age [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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


Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colostrum
oropharyngeal administration of own mother's colostrum
 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.
Placebo Comparator: Placebo
oropharyngeal administration of sterile water
 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.

  Eligibility

Ages Eligible for Study:   up to 96 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536093

Contacts
Contact: Han-Suk Kim, MD, PhD 82-2-2072-1696 kimhans@snu.ac.kr
Contact: Juyoung Lee, MD 82-2-2072-1836 lamb4122@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Children's Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Han-Suk Kim, MD, PhD     82-2-2072-1696     kimhans@snu.ac.kr    
Contact: Juyoung Lee, MD     82-2-2072-0647     lamb4122@snu.ac.kr    
Principal Investigator: Han-Suk Kim, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Han-Suk Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01536093     History of Changes
Other Study ID Numbers: OAC-01-ELGAN
Study First Received: January 6, 2012
Last Updated: January 2, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on May 22, 2013