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.

Study Overview

• Status: Completed
• Conditions: Premature Infant; Extremely Low Gestational Age Newborn
• Intervention / Treatment: Other: oropharyngeal administration of own mother's colostrum; Other: oropharyngeal administration of sterile water

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 4 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary Secretary IgA Concentration at 2 Weeks of Age	2 weeks of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Secretary IgA Concentration at 1 Week of Age		1 week of age
Salivary TGF-beta 1 Concentration at 2 Week of Age		2 week of age
Salivary IL-8 Concentration at 2 Weeks of Age		2 weeks of age
Concentration of Urinary Lactoferrin		1 week of age
Concentration of Urinary IL-1 Beta		2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines		1 week of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines		2 weeks of age
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
Total Hospital Admission Duration	days from admission to discharge from NICU	up to 4 months of age
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
Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2		from date of randomization up to 4 months of age
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
Development of Bronchopulmonary Dysplasia ≥ Moderate		up to 4 months of age
Development of Intraventricular Hemorrhage ≥ Grade 3		up to 4 months of age
In-hospital Death		up to 4 months of age
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 6, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: OAC-01-ELGAN