Phase 2
N=48
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Extremely Low Gestational Age Newborn · Premature Infant
Bottom Line
View on ClinicalTrials.gov: NCT01536093 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Urinary Secretary IgA Concentration at 2 Weeks of Age — 233.8; 48.3 ng per g creatinine — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oropharyngeal administration of own mother's colostrum (Other); oropharyngeal administration of sterile water (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Secretary IgA Concentration at 2 Weeks of Age |
233.8; 48.3 | 0.006 sig |
| SECONDARY Urinary Secretary IgA Concentration at 1 Week of Age |
71.4; 26.5 | 0.043 sig |
| SECONDARY Salivary TGF-beta 1 Concentration at 2 Week of Age |
39.2; 69.7 | 0.032 sig |
| SECONDARY Salivary IL-8 Concentration at 2 Weeks of Age |
2.58; 4.90 | 0.038 sig |
| SECONDARY Concentration of Urinary Lactoferrin |
3.51; 0.98 | 0.010 sig |
| SECONDARY Concentration of Urinary IL-1 Beta |
55.25; 91.80 | 0.013 sig |
| SECONDARY Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines |
— | — |
| SECONDARY Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines |
— | — |
| SECONDARY Time to Reach Full Feeding |
— | — |
| SECONDARY Total Hospital Admission Duration |
— | — |
| SECONDARY Episodes of Culture Positive Sepsis |
— | — |
| SECONDARY Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2 |
— | — |
| SECONDARY Episodes of Pneumonia |
— | — |
| SECONDARY Development of Bronchopulmonary Dysplasia ≥ Moderate |
— | — |
| SECONDARY Development of Intraventricular Hemorrhage ≥ Grade 3 |
— | — |
| SECONDARY In-hospital Death |
— | — |
| SECONDARY Development of Adverse Effects |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01536093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.