Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

Phase 2

Completed

• Conditions: Extremely Low Gestational Age Newborn; Premature Infant
• Interventions: Other: oropharyngeal administration of own mother's colostrum; Other: oropharyngeal administration of sterile water

• Registration Number: NCT01536093
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-07-17
• Results First Submitted QC: 2014-07-17
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-11
• Results First Posted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum	oropharyngeal administration of own mother's colostrum	oropharyngeal administration of own mother's colostrum
Placebo	oropharyngeal administration of sterile water	oropharyngeal administration of sterile water

Primary Outcome Measures

Name	Time	Method
Urinary Secretary IgA Concentration at 2 Weeks of Age	2 weeks of age

Secondary Outcome Measures

Name	Time	Method
In-hospital Death	up to 4 months of age
Total Hospital Admission Duration	up to 4 months of age	days from admission to discharge from NICU
Concentration of Urinary Lactoferrin	1 week of age
Time to Reach Full Feeding	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
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 IL-1 Beta	2 weeks of age
Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines	2 weeks of age
Episodes of Culture Positive Sepsis	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)
Development of Intraventricular Hemorrhage ≥ Grade 3	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	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	up to 4 months of age
Development of Adverse Effects	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

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of