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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Frequent Standardized Oral Care for premature infants?

Research on similar treatments, like standardized feeding protocols and the SOFFI feeding program, shows that structured approaches can improve feeding performance and reduce hospital stay for preterm infants. These findings suggest that standardized care practices, including oral care, may help improve health outcomes for premature infants. ^{1 2 3 4 5}

Is standardized oral care safe for humans?

Research on standardized oral care in children, including those with cancer, suggests it is generally safe and helps prevent oral mucositis (painful inflammation and sores in the mouth). ^{3 6 7 8 9}

How is the Frequent Standardized Oral Care treatment different from other treatments for premature infants?

Frequent Standardized Oral Care is unique because it provides a consistent approach to oral care for premature infants, which can help improve feeding practices and reduce the length of stay in the NICU. Unlike other treatments that rely on individual judgment, this standardized method aims to decrease variability and improve outcomes. ^{2 4 10 11 12}

Research Team

Leslie Parker

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improving Nutrition Outcomes for Infants [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improving preterm infant outcomes: implementing an evidence-based oral feeding advancement protocol in the neonatal intensive care unit. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of feeding experience on clinical outcomes in preterm infants. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical significance of oral motor intervention on the prognosis of early premature infant]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Setting the stage for successful oral feeding: the impact of implementing the SOFFI feeding program with medically fragile NICU infants. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

Implementation of a hospital oral care protocol and recording of oral mucositis in children receiving cancer treatment : a retrospective and a prospective study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of Oral Care Using an Oral Health Care Guide on Preventing Mucositis in Pediatric Intensive Care. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of the risk factors of dental caries in children with very low birth weight and normal birth weight. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Non-nutritive sucking evaluation in preterm newborns and the start of oral feeding: a multicenter study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Quality Improvement Project to Reduce Time to Full Enteral Feeds for Very Low Birth Weight Neonates. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Clinicians guide for cue-based transition to oral feeding in preterm infants: An easy-to-use clinical guide. [2021]