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Behavioural Intervention

Human Milk-Based Oral Care for Respiratory Disorders in Premature Babies

N/A

Recruiting

Led By Leslie Parker, PHD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Born weighing ≤ 1500 grams

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-60 days

Awards & highlights

Study Summary

This trial will study how frequent, standardized oral care can reduce complications in premature babies.

Who is the study for?

This trial is for very low birth weight (VLBW) infants born at or before 30 weeks of gestation and weighing less than or equal to 1500 grams. The mother must be at least 18 years old. Infants with facial, lung, or gastrointestinal anomalies, or those not expected to live more than a week after delivery cannot participate.Check my eligibility

What is being tested?

The study tests the effects of frequent standardized oral care on premature infants in the NICU. It aims to see if this care can reduce complications like bronchopulmonary dysplasia and various types of pneumonia by preventing an overgrowth of harmful bacteria in their mouths.See study design

What are the potential side effects?

Since the intervention involves non-invasive oral care using human milk, side effects are minimal but may include discomfort during the cleaning process.

Eligibility Criteria

Inclusion Criteria

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

Select...

I was born weighing 1500 grams or less.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with oral microbiome dysbiosis.

Secondary outcome measures

Number of days requiring respiratory support

Number of participants with bronchopulmonary dysplasia

Number of participants with ventilator associated pneumonia

Trial Design

3Treatment groups

Active Control

Group I: Group 1Active Control1 Intervention

Standardized oral care performed every 3-4 hours using human milk, donor or breast milk.

Group II: Group 2Active Control1 Intervention

Standardized oral care performed every 3-4 hours using sterile water.

Group III: Group 3Active Control1 Intervention

Standardized oral care performed every 12 hours using sterile water.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,428 Total Patients Enrolled

1 Trials studying Bacterial Pneumonia

43 Patients Enrolled for Bacterial Pneumonia

The Gerber FoundationOTHER

41 Previous Clinical Trials

5,778 Total Patients Enrolled

Leslie Parker, PHDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for participation in this experiment restricted to individuals aged thirty or younger?

"The requirements for this study necessitate that potential participants be younger than 3 Days and older than 1 Hour."

Answered by AI

Do I satisfy the prerequisites for inclusion in this trial?

"The qualifications necessary to be accepted into this trial are bronchopulmonary dysplasia and an age range of 1 hour old up to 3 days. Currently, 218 participants are being recruited for the study."

Answered by AI

Are there any vacancies available for potential participants in this trial?

"As of this time, clinicaltrials.gov confirms that no new patients are being recruited for the trial initially posted on September 23rd 2023 and last updated on September 5th 2023. However, 168 other trials are still actively taking partcipants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

2023. "Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06000761.