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NCT Number: NCT02389478

Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oropharyngeal administration of colostrums

Procedure

rubbing drops of colostrum inside a baby's cheeks using a sterile syringe

Other names: oral immune therapy

Oropharyngeal administration of Normal saline

Procedure

rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Fudan University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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