Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

Premature Infant Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536093
• Other study ID #: OAC-01-ELGAN
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2012
• Last updated: August 11, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 96 Hours

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Extremely Low Gestational Age Newborn
• Premature Infant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Secretary IgA Concentration at 2 Weeks of Age		2 weeks of age	No
Secondary	Urinary Secretary IgA Concentration at 1 Week of Age		1 week of age	No
Secondary	Salivary TGF-beta 1 Concentration at 2 Week of Age		2 week of age	No
Secondary	Salivary IL-8 Concentration at 2 Weeks of Age		2 weeks of age	No
Secondary	Concentration of Urinary Lactoferrin		1 week of age	No
Secondary	Concentration of Urinary IL-1 Beta		2 weeks of age	No
Secondary	Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines		1 week of age	No
Secondary	Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines		2 weeks of age	No
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	up to 2 months of age	No
Secondary	Total Hospital Admission Duration	days from admission to discharge from NICU	up to 4 months of age	No
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)	from date of randomization up to 4 months of age	No
Secondary	Episodes of Necrotizing Enterocolitis = Bell's Stage 2		from date of randomization up to 4 months of age	No
Secondary	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	No
Secondary	Development of Bronchopulmonary Dysplasia = Moderate		up to 4 months of age	No
Secondary	Development of Intraventricular Hemorrhage = Grade 3		up to 4 months of age	No
Secondary	In-hospital Death		up to 4 months of age	No
Secondary	Development of Adverse Effects	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	from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age	Yes