Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

Study Overview
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Brief Summary
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The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.

Detailed Description
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The number of very low born weight infants increased every year.they are suffer from many questions.Recent studies have shown that Oropharyngeal administration of colostrum to very low birth weight infants can reduce the time reach full enteral nutrition .But there are no evidence support that it can promote infants' immune response. The hypothesis of the current study is that Oropharyngeal administration of colostrum to very low birth weight infants may increase the secretion of sIgA in urine and saliva. The current study adopts randomized, double blind, controlled intervention trial, gives Oropharyngeal administration of colostrums to very low birth weight infants in intervention group and Oropharyngeal administration of Normal saline to control group. All indicators in this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC) occurred， the investigators use Chi-square tests for comparisons between two groups. The study expects that Oropharyngeal administration of colostrum to very low birth weight infants can increase the secretion of sIgA in urine and saliva.

Official Title
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Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants：Effects on Secretory Immunoglobulin A

Conditions
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Infant, Very Low Birth Weight

Intervention / Treatment
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* Procedure: Oropharyngeal administration of colostrums
* Procedure: Oropharyngeal administration of Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born weight≤1500g transferred to our hospital within 24 hours after birth the mother can provide colostrum parents of the infants agreed to participate in this study Exclusion Criteria: The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected <30d The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.） human milk is contraindicated An infant whose mother : Is infected with the human immunodeficiency virus (HIV) Is taking antiretroviral medications Has untreated active tuberculosis Is infected with human T-cell lymphotropic virus type l or ll Is using or dependent on an illicit drug except if the breastmilk is medically indicated Is taking prescribed cancer chemotherapy agents contraindicated for breastfeeding Is receiving any medications contraindicated in breast feeding Is receiving diagnostic or therapeutic radioactive isotopes or exposure to radioactive materials (for as long as they are radioactive in the milk) An infant diagnosed with galactosemia, a rare genetic metabolic disorder

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colostrums<br>Oropharyngeal administration of colostrums, every 4 hours，continue for 7days | Procedure: Oropharyngeal administration of colostrums<br>* rubbing drops of colostrum inside a baby's cheeks using a sterile syringe<br>* Other names: oral immune therapy;|
| Other: Normal saline<br>Oropharyngeal administration of Normal saline,every 4 hours，continue for 7days | Procedure: Oropharyngeal administration of Normal saline<br>* rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in sIgA at 7 days | in urine and saliva | at baseline（first time baby in hospital） and at 7 days | 
| Change from Baseline in lactoferrin at 7 days | in urine and saliva | at baseline（first time baby in hospital） and at 7 days | 
| Change from Baseline in sIgA at 21 days | in urine and saliva | at baseline（first time baby in hospital） and at 21 days | 
| Change from Baseline in lactoferrin at 21 days | in urine and saliva | at baseline（first time baby in hospital） and at 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration from admission to the start of oral feeding | when the first time participants start bottle feeding by mouth（>5ml/once） | participants will be followed for the duration of hospital stay, an expected average of 3 days | 
| The duration from the start of enteric feeding to full enteric feeding | when the volume of milk participants take by mouth up to 140ml/kg/day | participants will be followed for the duration of hospital stay, an expected average of 14 days | 
| The number of participants with necrotizing enterocolitis (NEC) |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharyngeal, breastmilk, colostrum, human milk, premature infant