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

Trial Summary

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 data supports the effectiveness of the treatment Human Milk-Based Oral Care for Respiratory Disorders in Premature Babies?

Research suggests that using colostrum (the first form of milk produced by mothers) as oral immune therapy can help premature babies by supporting their immune system and improving feeding tolerance. Although more studies are needed, early evidence indicates that this treatment is safe and may reduce the time needed to reach full feeding, offering potential benefits for vulnerable infants. ^{1 2 3 4 5}

Is human milk-based oral care safe for premature babies?

Research shows that using mother's own colostrum (the first form of milk) for oral care in premature babies is safe, well-tolerated, and poses little risk. It is a practice that can support immune development and is considered feasible even for the smallest premature infants. ^{1 2 3 4 6}

How is the treatment 'Human Milk-Based Oral Care for Respiratory Disorders in Premature Babies' different from other treatments?

This treatment is unique because it uses mother's own milk, specifically colostrum, applied directly to the mouth of premature babies to provide immune protection and support early feeding, which is different from traditional feeding methods that rely on tube feeding or formula. ^{1 2 3 4 7}

What is the purpose of this trial?

Premature 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 dysbiosis (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 168 VLBW infants for 4 weeks following birth.

Research Team

Leslie Parker

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Oral Care with Mother's Own Milk in Sick and Preterm Neonates: A Quality Improvement Initiative. [2021]

2. United States 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. [2023]

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

Colostrum as oral immune therapy to promote neonatal health. [2022]

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

Oropharyngeal Mother's Milk: State of the Science and Influence on Necrotizing Enterocolitis. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

Oropharyngeal colostrum immunotherapy and risk reduction of mortality in very low birth weight premature newborns: a clinical trial. [2023]

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

Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding in Preterm Infants: A Pilot Randomized Control Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study. [2021]