Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

NCT ID: NCT02389478

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-10-31

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.

Conditions

Infant, Very Low Birth Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

colostrums

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

Group Type: EXPERIMENTAL

Oropharyngeal administration of colostrums

Intervention Type: PROCEDURE

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

Normal saline

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

Group Type: OTHER

Oropharyngeal administration of Normal saline

Intervention Type: PROCEDURE

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

Interventions

Oropharyngeal administration of colostrums

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

Intervention Type: PROCEDURE

Oropharyngeal administration of Normal saline

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

Intervention Type: PROCEDURE

Other Intervention Names

oral immune therapy

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhang YuXia, doctor

Role: STUDY_CHAIR

Children Hospital of Fudan University

References

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.

Reference Type: BACKGROUND

PMID: 18769379 (View on PubMed)

Other Identifiers

FNF201421

Identifier Type: -

Identifier Source: org_study_id