Clinical Trial: Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Children's Hospital of Fudan University

Current Primary Outcome:

• Change from Baseline in sIgA at 7 days [ Time Frame: at baseline（first time baby in hospital） and at 7 days ]
  in urine and saliva
• Change from Baseline in lactoferrin at 7 days [ Time Frame: at baseline（first time baby in hospital） and at 7 days ]
  in urine and saliva
• Change from Baseline in sIgA at 21 days [ Time Frame: at baseline（first time baby in hospital） and at 21 days ]
  in urine and saliva
• Change from Baseline in lactoferrin at 21 days [ Time Frame: at baseline（first time baby in hospital） and at 21 days ]
  in urine and saliva

Original Primary Outcome: Same as current

Current Secondary Outcome:

• The duration from admission to the start of oral feeding [ 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）
• The duration from the start of enteric feeding to full enteric feeding [ 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
• The number of participants with necrotizing enterocolitis (NEC) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Original Secondary Outcome:

• The duration from admission to the start of oral feeding [ 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）
• The duration from the start of enteric feeding to full enteric feeding [ 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
• The number of partipitants with necrotizing enterocolitis (NEC) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Information By: Children's Hospital of Fudan University

Dates:
Date Received: February 8, 2015
Date Started: March 2015
Date Completion:
Last Updated: November 9, 2015
Last Verified: November 2015