Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

NCT01536093 | Completed Phase 2 Results DMC

• 1 other identifier: OAC-01-ELGAN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.

Conditions

Extremely Low Gestational Age Newborn; Premature Infant

Outcome Measures

Primary Outcomes (1)

• Urinary Secretary IgA Concentration at 2 Weeks of Age

  2 weeks of age

Secondary Outcomes (16)

• Urinary Secretary IgA Concentration at 1 Week of Age

  1 week of age

• Salivary TGF-beta 1 Concentration at 2 Week of Age

  2 week of age

• Salivary IL-8 Concentration at 2 Weeks of Age

  2 weeks of age

• Concentration of Urinary Lactoferrin

  1 week of age

• Concentration of Urinary IL-1 Beta

  2 weeks of age

Study Arms (2)

Colostrum

EXPERIMENTAL

oropharyngeal administration of own mother's colostrum

Other: oropharyngeal administration of own mother's colostrum

Placebo

PLACEBO COMPARATOR

oropharyngeal administration of sterile water

Other: oropharyngeal administration of sterile water

Interventions

oropharyngeal administration of own mother's colostrum OTHER

application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Colostrum

oropharyngeal administration of sterile water OTHER

application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Placebo

Eligibility Criteria

• Age: 48 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth
• parents of the infant signed to the informed consent form with voluntary agreement

You may not qualify if:

• infants with major congenital anomalies or chromosomal syndromes
• infants of mothers not willing to provide colostrum in the first week of life
• infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.

  PMID: 25624376 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Juyoung Lee
• Organization: Seoul National University College of Medicine

lamb4122@snu.ac.kr

82-31-787-7301

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: February 20, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 13, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-08

Locations

KR (1)