Standardized Oral Care for Premature Infant Health

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Congenital anomalies, Not expected to survive

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best oral care method for premature infants with very low birth weight (VLBW) to prevent complications. Researchers will compare two groups: one receiving frequent standardized oral care every 3-4 hours and another every 12 hours. They seek to identify which method better supports the babies' health, particularly in reducing lung issues like pneumonia. The study will track changes in the infants' mouth bacteria and their need for breathing support. Babies born before 32 weeks and weighing less than 1500 grams may be eligible to join. As an unphased trial, this study provides a unique opportunity to contribute to vital research that could improve care for vulnerable infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this oral care protocol is safe for premature infants?

Research has shown that regular oral care can benefit premature babies. A review of five studies found that oral care promotes a healthier balance of bacteria in the mouths and airways of very sick infants. This balance may prevent the growth of harmful bacteria, potentially reducing infections.

The reviewed studies did not report any major harm from regular oral care, indicating it is generally safe. However, each baby may react differently, so careful monitoring remains essential.

The current trial is not in a phase that typically tests safety, so direct evidence on possible risks is limited. Nonetheless, positive results from other studies suggest that regular oral care is likely safe for premature babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the frequency of oral care might impact the health of premature infants. Unlike the standard practice that involves less frequent oral care, this trial investigates the effects of providing oral care every 3-4 hours. The goal is to determine if more frequent oral hygiene can better prevent infections and improve overall health outcomes in these vulnerable newborns. By examining these variations in care frequency, researchers hope to identify a more effective routine that could become a new standard in neonatal care.

What evidence suggests that frequent standardized oral care is effective for premature infants?

Research has shown that regular oral care can help balance bacteria in the mouth. In very sick adults, maintaining this balance can prevent issues like infections. Although data for very low birth weight (VLBW) infants is not yet available, this method is expected to benefit them as well by targeting the same harmful bacteria. Early results suggest that frequent oral care might improve the health of VLBW infants by reducing the risk of breathing problems and infections. In this trial, infants will receive standardized oral care either every 12 hours or every 3-4 hours. This is crucial because a healthy mouth can lead to better breathing and feeding, which are vital for preterm babies. ^{1 3 5 6 7}

Who Is on the Research Team?

Leslie Parker

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for premature infants with a birth weight under 1500 grams and gestational age less than 32 weeks. Their mothers must be English-speaking adults over 18 years old. Infants with facial, lung, or gastrointestinal anomalies or those not expected to survive are excluded.

Inclusion Criteria

I am a mother and I speak English.

My birth weight was under 1500 grams.

I am over 18 years old.

Exclusion Criteria

It is not expected for you to live through the study.

I was born with abnormalities in my face, lungs, or digestive system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive standardized oral care every 3-4 hours or every 12 hours for 4 weeks

4 weeks

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 100 days

What Are the Treatments Tested in This Trial?

Interventions

• Frequent Standardized Oral Care

Trial Overview The study tests how often standardized oral care should be given to very low birth weight infants to prevent infections like pneumonia. It compares the effects of providing this care every 3-4 hours versus every 12 hours on their respiratory health outcomes.

How Is the Trial Designed?

Group I: every 3-4 hour oral care Experimental Treatment 1 Intervention

Infants will receive standardized oral care every 3-4 hours for 4 weeks

Group II: every 12 hour oral care Active Control 1 Intervention

Infants will receive standardized oral care every 12 hours for 4 weeks

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

A study of 293 preterm infants under 1500 g birthweight showed that implementing a rapid enteral feeding protocol led to faster achievement of full feedings and earlier weight regain without increasing the risk of feeding-related complications.

Infants in the rapid feeding group were more successfully stabilized on noninvasive ventilation and did not require mechanical ventilation, indicating that this feeding approach is safe and effective for improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. Behnke, J., Estreich, V., Oehmke, F., et al.[2022]

Citations

1. nature.com nature.com/articles/s41372-023-01675-8

A decade of evidence: standardized feeding initiative ... Over 93% successfully attained full oral feedings. Earlier acquisition of feeding milestones correlated with earlier discharge (P < 0.05). Year- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1355184118301315

Oral feeding readiness and premature infant outcomes Preterm infants who demonstrated greater oral feeding readiness achieved full oral feeding sooner (P < 0.0001) and were discharged earlier from the hospital (P ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05167318

Frequent Standardized Oral Care to Improve Health ... Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit. ClinicalTrials.gov ID NCT05167318.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8700416/

Feeding Problems and Long-Term Outcomes in Preterm ... This review provides an overview of the physiology of swallowing and oral feeding skills, disruptions to oral feeding in preterm infants, the outcomes of ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/61/NCT06000761/Prot_000.pdf

Frequent Standardized Oral Care to Improve Health ... 8. Possible Benefits: Frequent and standardized oral care may improve the health of VLBW infants by reducing oral dysbiosis and its associated ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05167318

Frequent Standardized Oral Care to Improve Health ... Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of ...

7. aacnjournals.org aacnjournals.org/ccnonline/article/43/4/39/32155/Oral-Care-in-Critically-Ill-Infants-and-the

Oral Care in Critically Ill Infants and the Potential Effect on ... This review of 5 studies yielded evidence that oral care may promote a more commensal oral and endotracheal tube aspirate microbiome.