Oropharyngeal administration of colostrums
Procedurerubbing drops of colostrum inside a baby's cheeks using a sterile syringe
Other names: oral immune therapy
NCT Number: NCT02389478
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.
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All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
Other names: oral immune therapy
rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
Time frame: at baseline(first time baby in hospital) and at 7 days
in urine and saliva
Time frame: at baseline(first time baby in hospital) and at 7 days
in urine and saliva
Time frame: at baseline(first time baby in hospital) and at 21 days
in urine and saliva
Time frame: at baseline(first time baby in hospital) and at 21 days
in urine and saliva
Time frame: 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)
Time frame: 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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Children's Hospital of Fudan University
Other
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants:Effects on Secretory Immunoglobulin A
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