Infant, Very Low Birth Weight
Conditions
Keywords
oropharyngeal, breastmilk, colostrum, human milk, premature infant
Brief summary
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
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.
Interventions
PROCEDUREOropharyngeal administration of colostrums
rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
PROCEDUREOropharyngeal administration of Normal saline
rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
Sponsors
Fudan University
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
Inclusion criteria
1. Born weight≤1500g 2. transferred to our hospital within 24 hours after birth 3. the mother can provide colostrum 4. parents of the infants agreed to participate in this study
Exclusion criteria
1. The infants suffering from life-threatening conditions ,such as severe heart disease,whose survival time are expected \<30d 2. The infants suffering from any kinds of disease,which impact they take human milk by mouth.(such as gastrointestinal malformations, NEC, etc.） 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in sIgA at 7 days | at baseline（first time baby in hospital） and at 7 days | in urine and saliva |
| Change from Baseline in lactoferrin at 7 days | at baseline（first time baby in hospital） and at 7 days | in urine and saliva |
| Change from Baseline in sIgA at 21 days | at baseline（first time baby in hospital） and at 21 days | in urine and saliva |
| Change from Baseline in lactoferrin at 21 days | at baseline（first time baby in hospital） and at 21 days | in urine and saliva |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration from the start of enteric feeding to full enteric feeding | participants will be followed for the duration of hospital stay, an expected average of 14 days | when the volume of milk participants take by mouth up to 140ml/kg/day |
| The number of participants with necrotizing enterocolitis (NEC) | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | — |
| The duration from admission to the start of oral feeding | participants will be followed for the duration of hospital stay, an expected average of 3 days | when the first time participants start bottle feeding by mouth（\>5ml/once） |
Outcome results
None listed