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

Overseen By Leslie A Parker, PhD, APRN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Congenital anomalies, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

218 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to provide oral care for premature babies to prevent complications from harmful bacteria in the mouth. It compares different methods: using human milk every 3-4 hours, using sterile water every 3-4 hours, and using sterile water every 12 hours. The goal is to determine which method helps premature babies, born at 30 weeks or earlier and weighing 1500 grams or less, stay healthier. Babies with certain facial, lung, or digestive issues are not eligible for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could improve care for premature infants.

Do I need to stop my current medications for this trial?

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

What prior data suggests that standardized oral care with human milk is safe for premature infants?

Research shows that using human milk for oral care in premature babies is generally safe. Several studies have found that placing colostrum (the first milk produced by mothers) in the mouths of preterm babies is both safe and practical. No major safety issues have arisen when this occurs within the first 48 hours after birth.

Using sterile water is also usually safe. Medical settings commonly use it to clean and hydrate, and babies tolerate it well.

Overall, both human milk and sterile water are considered safe for oral care in preterm infants. Research indicates they are well-tolerated and do not cause major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the human milk-based oral care for premature babies with respiratory disorders because it uses human milk, either donor or breast milk, instead of the typical sterile water. Human milk is rich in bioactive components that could provide protective benefits and promote better health outcomes for these vulnerable infants. This approach could offer a more natural way to support oral and respiratory health in premature babies, potentially reducing the incidence of respiratory complications. By comparing different frequencies and types of oral care, the trial aims to uncover the most effective method for enhancing care in neonatal units.

What evidence suggests that standardized oral care with human milk could be effective for respiratory disorders in premature babies?

This trial will compare different methods of standardized oral care for premature babies. Research has shown that using a mother's milk for oral care in premature babies can be beneficial. Participants in Group 1 will receive oral care every 3-4 hours using human milk, which studies have found can lower the risk of necrotizing enterocolitis, a serious intestinal disease. Other research suggests that early oral care with human milk is safe and practical, as it helps reduce harmful bacteria in the mouth. This practice has been linked to positive outcomes in neonatal intensive care units, especially with regular use. Overall, using human milk for oral care in premature infants appears promising in improving their health by reducing the risk of complications. ^{1 3 4 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 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.

Inclusion Criteria

You are less than 30 weeks pregnant.

I was born weighing 1500 grams or less.

I am a mother and I am 18 years old or older.

Exclusion Criteria

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

It is not expected for you to live more than 7 days after giving birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Standardized oral care performed every 3-4 hours using human milk or sterile water

4 weeks

Continuous care in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extended Monitoring

Monitoring for respiratory support and bronchopulmonary dysplasia

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standardized Oral Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 1 Active Control 1 Intervention

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

Group II: Group 2 Active Control 1 Intervention

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

Group III: Group 3 Active Control 1 Intervention

Standardized oral care performed every 12 hours using sterile water.

Standardized Oral Care is already approved in United States, European Union for the following indications:

Approved in United States as Standardized Oral Care with Human Milk for:

• Prevention of oral dysbiosis and associated complications in premature infants

Approved in European Union as Oral Immune Therapy (OIT) with Mother's Own Milk (MOM) for:

• Promotion of immune function in premature neonates
• Prevention of ventilator-associated pneumonia

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

The Gerber Foundation

Collaborator

Trials

45

Recruited

6,200+

Published Research Related to This Trial

Oropharyngeal colostrum immunotherapy (OCI) significantly reduced the risk of mortality in preterm newborns with very low birth weight, showing a relative risk of death of 0.26 compared to the control group.

For every 5 preterm newborns treated with OCI, one death was prevented, indicating a Number Needed to Treat (NNT) of 4.9, which improves further for those hospitalized longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal colostrum immunotherapy and risk reduction of mortality in very low birth weight premature newborns: a clinical trial. Martins, CDC., Ramos, MSX., Lyrio, AO., et al.[2023]

Oropharyngeal administration of mother's own milk may mimic the protective effects of amniotic fluid, potentially reducing the risk of necrotizing enterocolitis in extremely low birth weight infants.

This method, known as OroPharyngeal Therapy with Mother's Own Milk (OPT-MOM), is proposed as an immunomodulatory therapy to complement enteral feeding, suggesting a new approach to enhance the health of vulnerable neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal Mother's Milk: State of the Science and Influence on Necrotizing Enterocolitis. Garofalo, NA., Caplan, MS.[2019]

Oropharyngeal administration of mother's milk (OPAMM) did not significantly reduce the incidence of nosocomial sepsis in preterm infants, with rates of 8% in the OPAMM group compared to 13% in the control group.

However, OPAMM was associated with beneficial outcomes such as earlier achievement of full feeding, shorter hospital stays, and reduced growth of Klebsiella species, indicating potential advantages in feeding tolerance and respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding in Preterm Infants: A Pilot Randomized Control Trial. Abd-Elgawad, M., Eldegla, H., Khashaba, M., et al.[2021]

A quality improvement initiative successfully increased the use of oral care with mother's own milk (OC-MOM) in sick and preterm neonates from 5.9% to 83.3% over a 6-month period, demonstrating the effectiveness of the implemented protocol.

The initiative also significantly improved the oral health of neonates, as indicated by the increase in the Mouth Assessment Tool (MAT) score of '0' from 24.4% to 94.4%, highlighting the positive impact of OC-MOM on neonatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Care with Mother's Own Milk in Sick and Preterm Neonates: A Quality Improvement Initiative. Digal, KC., Upadhyay, J., Singh, P., et al.[2021]

A quality improvement initiative successfully increased early oral immune therapy (OIT) administration in very low birthweight infants from 6% to 55% over 12 months, demonstrating the effectiveness of structured interventions in neonatal care.

Total OIT administration (both early and late) also rose significantly from 21% to 85%, indicating a substantial enhancement in the use of colostrum as a therapeutic approach for these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Early Colostrum Administration to Very Low Birth Weight Infants in a Level 3 Neonatal Intensive Care Unit: A Quality Improvement Initiative. Fleiss, N., Morrison, C., Nascimento, A., et al.[2023]

Oropharyngeal colostrum administration in very low birth weight preterm newborns is being tested as a feasible immunotherapy strategy, with a protocol involving 0.2 mL of raw colostrum given 8 times daily for the first week of life.

The study aims to improve clinical care in a public hospital setting by implementing a systematic algorithm for administering colostrum, which could enhance the quality of care and support the health of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study. da Cruz Martins, C., de Santana Xavier Ramos, M., Viana Cardoso Amaral, M., et al.[2021]

Own mother's colostrum (OMC) administered oropharyngeally is a safe and well-tolerated method for delivering oral immune therapy to premature infants, potentially supporting their immune development even before they start enteral feedings.

Preliminary evidence suggests that OMC may help reduce the time to full enteral feedings in premature infants, although more robust studies are needed to clarify its effects on serious outcomes like necrotizing enterocolitis and sepsis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colostrum as oral immune therapy to promote neonatal health. Gephart, SM., Weller, M.[2022]

Citations

1. hopkinsmedicine.org hopkinsmedicine.org/-/media/files/allchildrens/clinical-pathways/oral-immune-therapy-11_29_2023.pdf

Oral Immune Therapy (OIT) with Mother's Own Milk (MOM) ... Multiple studies in premature infants have found that oral care with colostrum is a feasible and safe practice when initiated in the first 48 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10104743/

Oral Application of Mother's Own Milk for Reducing ... The results of this updated meta-analysis showed that compared to the placebo, mother's milk provides better effects in reducing the incidences of NEC, proven ...

3. tp.amegroups.org tp.amegroups.org/article/view/143711/html

Enhancing early mother's own milk (MOM) use in NICU ... Enhancing early mother's own milk (MOM) use in NICU preterm infants with colostrum oral immune therapy (COIT): evidence summary.

4. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/bfm.2024.0214

Oral Care Performed with Breast Milk in Preterm Newborns ... Objective:This study examined the effect of breast milk on oral care practices in neonatal intensive care units.Methods:This study involved 64 preterm ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04454502?cond=Colostrum&viewType=Table&rank=3

Analysis of the Effects of Oral Colostrum Administration in ... The aim of this study was to analyze the effect of oral (oropharyngeal) colostrum administration in very low birth weight premature infants (between 1000-1500 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4603349/

Oropharyngeal administration of mother's colostrum, health ... A 5-year, multi-center, double-blind, randomized controlled trial designed to evaluate the safety and efficacy of oropharyngeal mother's milk.

7. ijn.mums.ac.ir ijn.mums.ac.ir/article_17393_1c5219fd9b902148f873fd924f7aaa9d.pdf

Randomized Controlled Trial of Oral Immunotherapy with ... Results: According to the obtained results, there was no statistical difference among the preterm babies who received oral immunotherapy with colostrum, breast ...