Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Very Low Birth Weight
• Intervention / Treatment: Procedure: Oropharyngeal administration of colostrums; Procedure: Oropharyngeal administration of Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: colostrums; Oropharyngeal administration of colostrums, every 4 hours，continue for 7days	Procedure: Oropharyngeal administration of colostrums; rubbing drops of colostrum inside a baby's cheeks using a sterile syringe; Other Names: oral immune therapy
Other: Normal saline; Oropharyngeal administration of Normal saline,every 4 hours，continue for 7days	Procedure: Oropharyngeal administration of Normal saline; rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in sIgA at 7 days	in urine and saliva	at baseline（first time baby in hospital） and at 7 days
Change from Baseline in lactoferrin at 7 days	in urine and saliva	at baseline（first time baby in hospital） and at 7 days
Change from Baseline in sIgA at 21 days	in urine and saliva	at baseline（first time baby in hospital） and at 21 days
Change from Baseline in lactoferrin at 21 days	in urine and saliva	at baseline（first time baby in hospital） and at 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The number of participants with necrotizing enterocolitis (NEC)		participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Fudan University
• Investigators: Study Chair: Zhang YuXia, doctor, Children Hospital of Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: colostrum; premature infant; human milk; breastmilk; oropharyngeal
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: FNF201421