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Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

Primary Purpose

Infant, Very Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oropharyngeal administration of colostrums
Oropharyngeal administration of Normal saline
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Very Low Birth Weight focused on measuring oropharyngeal, breastmilk, colostrum, human milk, premature infant

Eligibility Criteria

1 Day - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    colostrums

    Normal saline

    Arm Description

    Oropharyngeal administration of colostrums, every 4 hours，continue for 7days

    Oropharyngeal administration of Normal saline,every 4 hours，continue for 7days

    Outcomes

    Primary Outcome Measures

    Change from Baseline in sIgA at 7 days
    in urine and saliva
    Change from Baseline in lactoferrin at 7 days
    in urine and saliva
    Change from Baseline in sIgA at 21 days
    in urine and saliva
    Change from Baseline in lactoferrin at 21 days
    in urine and saliva

    Secondary Outcome Measures

    The duration from admission to the start of oral feeding
    when the first time participants start bottle feeding by mouth（>5ml/once）
    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
    The number of participants with necrotizing enterocolitis (NEC)

    Full Information

    First Posted
    February 8, 2015
    Last Updated
    November 9, 2015
    Sponsor
    Children's Hospital of Fudan University
    Collaborators
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02389478
    Brief Title
    Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
    Official Title
    Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants：Effects on Secretory Immunoglobulin A
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Fudan University
    Collaborators
    Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infant, Very Low Birth Weight
    Keywords
    oropharyngeal, breastmilk, colostrum, human milk, premature infant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    colostrums
    Arm Type
    Experimental
    Arm Description
    Oropharyngeal administration of colostrums, every 4 hours，continue for 7days
    Arm Title
    Normal saline
    Arm Type
    Other
    Arm Description
    Oropharyngeal administration of Normal saline,every 4 hours，continue for 7days
    Intervention Type
    Procedure
    Intervention Name(s)
    Oropharyngeal administration of colostrums
    Other Intervention Name(s)
    oral immune therapy
    Intervention Description
    rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
    Intervention Type
    Procedure
    Intervention Name(s)
    Oropharyngeal administration of Normal saline
    Intervention Description
    rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
    Primary Outcome Measure Information:
    Title
    Change from Baseline in sIgA at 7 days
    Description
    in urine and saliva
    Time Frame
    at baseline（first time baby in hospital） and at 7 days
    Title
    Change from Baseline in lactoferrin at 7 days
    Description
    in urine and saliva
    Time Frame
    at baseline（first time baby in hospital） and at 7 days
    Title
    Change from Baseline in sIgA at 21 days
    Description
    in urine and saliva
    Time Frame
    at baseline（first time baby in hospital） and at 21 days
    Title
    Change from Baseline in lactoferrin at 21 days
    Description
    in urine and saliva
    Time Frame
    at baseline（first time baby in hospital） and at 21 days
    Secondary Outcome Measure Information:
    Title
    The duration from admission to the start of oral feeding
    Description
    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 3 days
    Title
    The duration from the start of enteric feeding to full enteric feeding
    Description
    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 14 days
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    1 Month
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Born weight≤1500g transferred to our hospital within 24 hours after birth the mother can provide colostrum parents of the infants agreed to participate in this study 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 : 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhang YuXia, doctor
    Organizational Affiliation
    Children Hospital of Fudan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18769379
    Citation
    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.
    Results Reference
    background

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    Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

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