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oropharyngeal mother's milk for Ventilator-Associated Pneumonia

N/A
Waitlist Available
Led By Nancy A Garofalo (previously Rodriguez), PhD APN NNP
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Birthweight <1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days, 2 weeks, 32 weeks cga
Awards & highlights

Study Summary

This trial looks at whether giving extremely premature infants colostrum and milk from their own mothers can help protect them from infection and improve their health outcomes.

Eligible Conditions
  • Ventilator-Associated Pneumonia
  • Necrotizing Enterocolitis
  • Infections

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days, 2 weeks, 32 weeks cga
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days, 2 weeks, 32 weeks cga for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of necrotizing enterocolitis
Incidence of of late-onset sepsis
Incidence of ventilator-associated pneumonia
Secondary outcome measures
Changes in stool microbiome
Changes in urinary biomarkers of oxidative stress
Concentrations of lactoferrin in urine
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: oropharyngeal mother's milkExperimental Treatment1 Intervention
0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age
Group II: oropharyngeal sterile waterPlacebo Group1 Intervention
0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age

Find a Location

Who is running the clinical trial?

The Gerber FoundationOTHER
41 Previous Clinical Trials
5,736 Total Patients Enrolled
Fundacion Para La Investigacion Hospital La FeOTHER
10 Previous Clinical Trials
17,955 Total Patients Enrolled
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,600 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
TrialsJournal
Oropharyngeal Administration of Mother’s Colostrum, Health Outcomes of Premature Infants: Study Protocol for a Randomized Controlled Trial
Rodriguez, Nancy A., Maximo Vento, Erika C. Claud, Chihsiung E. Wang, and Michael S. Caplan. 2015. “Oropharyngeal Administration of Mother’s Colostrum, Health Outcomes of Premature Infants: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-015-0969-6.
clinicaltrials.govStudy
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Nancy Rodriguez 2013. "Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02116699.
~23 spots leftby Apr 2025
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