Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants

NCT02389478 | Completed DMC

• 1 other identifier: FNF201421
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Very Low Birth Weight

Keywords

oropharyngeal; breastmilk; colostrum; human milk; premature infant

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• The duration from admission to the start of oral feeding

  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

  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

Study Arms (2)

colostrums

EXPERIMENTAL

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

Procedure: Oropharyngeal administration of colostrums

Normal saline

OTHER

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

Procedure: Oropharyngeal administration of Normal saline

Interventions

Oropharyngeal administration of colostrums PROCEDURE

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

Also known as: oral immune therapy

colostrums

Oropharyngeal administration of Normal saline PROCEDURE

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

Normal saline

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Fudan University: collaborator

Related 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.

  PMID: 18769379 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Zhang YuXia, doctor

  Children Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11