Try our beta test site

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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Urinary Secretary IgA Concentration at 2 Weeks of Age [ Time Frame: 2 weeks of age ]

Secondary Outcome Measures:
  • 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 [ Time Frame: up to 2 months of age ]
    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 ]
    days from admission to discharge from NICU

  • Episodes of Culture Positive Sepsis [ Time Frame: from date of randomization up to 4 months of age ]
    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 ]
  • Episodes of Pneumonia [ Time Frame: from date of randomization up to 4 months of age ]
    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 ]
  • 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 [ Time Frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age ]

    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


Enrollment: 48
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536093

Locations
Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: July 17, 2014
Last Updated: August 11, 2014

ClinicalTrials.gov processed this record on February 17, 2017