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Completed

NCT Number: NCT01536093

Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

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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Key information

Conditions

Extremely Low Gestational Age Newborn Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infant Urogenital Diseases

Age range

48 hour–96 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Urinary Secretary IgA Concentration at 2 Weeks of Age

    Time frame: 2 weeks of age

Secondary outcomes

  1. Urinary Secretary IgA Concentration at 1 Week of Age

    Time frame: 1 week of age

  2. Salivary TGF-beta 1 Concentration at 2 Week of Age

    Time frame: 2 week of age

  3. Salivary IL-8 Concentration at 2 Weeks of Age

    Time frame: 2 weeks of age

  4. Concentration of Urinary Lactoferrin

    Time frame: 1 week of age

  5. Concentration of Urinary IL-1 Beta

    Time frame: 2 weeks of age

  6. Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines

    Time frame: 1 week of age

  7. Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines

    Time frame: 2 weeks of age

  8. 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

  9. Total Hospital Admission Duration

    Time frame: up to 4 months of age

    days from admission to discharge from NICU

  10. 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)

  11. Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2

    Time frame: from date of randomization up to 4 months of age

  12. 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

  13. Development of Bronchopulmonary Dysplasia ≥ Moderate

    Time frame: up to 4 months of age

  14. Development of Intraventricular Hemorrhage ≥ Grade 3

    Time frame: up to 4 months of age

  15. In-hospital Death

    Time frame: up to 4 months of age

  16. 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

    • general - fever or hypothermia, rash
    • respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia
    • gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis
    • renal - oliguria (urine output < 1.0cc/kg/day)
    • laboratory - hypo-/hyper-natremia, acidosis, hypercarbia

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 20, 2012
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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