Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

Infant, Very Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389478
• Other study ID #: FNF201421
• Status: Completed
• Phase: N/A
• First received: February 8, 2015
• Last updated: November 9, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

Intervention

Procedure:
• Oropharyngeal administration of colostrums
rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
• Oropharyngeal administration of Normal saline
rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Fudan University

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in sIgA at 7 days	in urine and saliva	at baseline(first time baby in hospital) and at 7 days	No
Primary	Change from Baseline in lactoferrin at 7 days	in urine and saliva	at baseline(first time baby in hospital) and at 7 days	No
Primary	Change from Baseline in sIgA at 21 days	in urine and saliva	at baseline(first time baby in hospital) and at 21 days	No
Primary	Change from Baseline in lactoferrin at 21 days	in urine and saliva	at baseline(first time baby in hospital) and at 21 days	No
Secondary	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	No
Secondary	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	No
Secondary	The number of participants with necrotizing enterocolitis (NEC)		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No