Infant, Very Low Birth Weight Clinical Trial
Official title:
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants:Effects on Secretory Immunoglobulin A
Verified date | November 2015 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 1 Month |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University | Fudan University |
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in sIgA at 7 days | in urine and saliva | at baseline(first time baby in hospital) and at 7 days | No |
Primary | Change from Baseline in lactoferrin at 7 days | in urine and saliva | at baseline(first time baby in hospital) and at 7 days | No |
Primary | Change from Baseline in sIgA at 21 days | in urine and saliva | at baseline(first time baby in hospital) and at 21 days | No |
Primary | Change from Baseline in lactoferrin at 21 days | in urine and saliva | at baseline(first time baby in hospital) and at 21 days | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | The number of participants with necrotizing enterocolitis (NEC) | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | No |
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