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| Name | Class |
|---|---|
| Fudan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colostrums | Experimental | Oropharyngeal administration of colostrums, every 4 hours,continue for 7days |
|
| Normal saline | Other | Oropharyngeal administration of Normal saline,every 4 hours,continue for 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oropharyngeal administration of colostrums | Procedure | rubbing drops of colostrum inside a baby's cheeks using a sterile syringe |
|
| 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 |
| 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 |
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Inclusion Criteria:
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 :
An infant diagnosed with galactosemia, a rare genetic metabolic disorder
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| Name | Affiliation | Role |
|---|---|---|
| Zhang YuXia, doctor | Children Hospital of Fudan University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18769379 | Background | Rodriguez NA, Meier PP, Groer MW, Zeller JM. Oropharyngeal administration of colostrum to extremely low birth weight infants: theoretical perspectives. J Perinatol. 2009 Jan;29(1):1-7. doi: 10.1038/jp.2008.130. Epub 2008 Sep 4. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Oropharyngeal administration of Normal saline | Procedure | rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe |
|
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 |
| D000091642 | Urogenital Diseases |