Breast Milk for Meconium Passage

(BEAM Trial)

MC
Overseen ByMonica C Gierbolini Collazo, MD
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether breast milk can help preterm infants pass their first stool, known as meconium. Passing meconium is crucial because delays can lead to serious gut problems. The treatment involves administering a small amount of the mother's own breast milk as a rectal enema to help clear the meconium. The trial seeks preterm infants born between 23 and 28 weeks who haven't passed meconium within the first 48 hours and have access to their mother's breast milk. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

Do I have to stop taking 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 this method is safe for preterm infants?

Studies have shown that using breast milk in enemas is safe and effective for helping premature babies pass their first stool, called meconium. This is important because passing meconium faster can lead to quicker feeding. Research indicates that breast milk gently stimulates the digestive system without causing harm. Specifically, one study found that babies receiving breast milk enemas passed meconium more quickly than those given saltwater enemas, with no major safety concerns reported. While researchers continue to study this treatment, current evidence is promising regarding its safety for infants.12345

Why are researchers excited about this trial?

Unlike standard treatments for delayed meconium passage, which typically involve glycerin suppositories or saline enemas, this new approach uses breast milk as a rectal enema. Researchers are excited about this treatment because breast milk is a natural, nutrient-rich substance that may encourage bowel movement more gently and effectively. Additionally, the use of a mother's own milk introduces beneficial components like antibodies and enzymes, which could promote gut health and reduce potential side effects associated with chemical-based treatments. This unique method could offer a more holistic and safer option for newborns experiencing this condition.

What evidence suggests that breast milk might be an effective treatment for meconium passage in preterm infants?

Research has shown that using breast milk as an enema can help premature babies pass their first stool, called meconium, more quickly. In this trial, participants will receive a small-volume rectal enema consisting of fresh mother's own breast milk. Studies have found that breast milk enemas work faster than saline enemas for this purpose. This method also helps babies start full feedings sooner. Breast milk contains substances that may improve gut movement and support healthy gut bacteria. These findings suggest that breast milk enemas could effectively help premature babies pass meconium.12678

Who Is on the Research Team?

RJ

Ricardo J Rodriquez, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for preterm infants who have not yet passed meconium (their first stool). The study aims to help these babies pass meconium more quickly, which may reduce risks linked to delayed bowel movements.

Inclusion Criteria

My baby was born between 24 and 27 weeks at or transferred to this hospital within 24 hours.
Availability of mother's own milk
Written informed consent obtained from a parent or legal guardian
See 1 more

Exclusion Criteria

I have had a spontaneous hole in my intestine.
My infant has been diagnosed with stage II or higher NEC.
Significant hematologic abnormalities such as neutropenia or thrombocytopenia
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Administration of a small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk, with an option for one repeat dose at 24 hours if clinically indicated

1-2 days
In-hospital administration

Follow-up

Participants are monitored for safety and effectiveness, including incidence of NEC, sepsis, and rectal or gastrointestinal injury

14 days
Regular in-hospital monitoring

Extended Follow-up

Monitoring of secondary outcomes such as time to achieve full enteral feeds, duration of parenteral nutrition, and total length of hospital stay

120 days

What Are the Treatments Tested in This Trial?

Interventions

  • Breast Milk

Trial Overview

The trial is testing whether giving a breast milk enema helps preterm infants pass their first stool faster compared to usual care methods like saline or glycerin enemas. Babies are assigned to receive the breast milk enema and monitored for results.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: breast milkExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Breast Milk Enema and Meconium Evacuation Among Preterm ...

In this randomized clinical trial testing the effects of breast milk enema on meconium evacuation, breast milk reduced the time to achieve ...

Clinical effects of breast milk enema on meconium ...

The primary outcomes will be the time to achieve complete meconium evacuation from birth and the time to achieve full enteral feeding from birth in preterm ...

Meconium obstruction of prematurity in tiny babies

In the study, preterm infants receiving enemas within the first 48 h after birth were found to have a significantly lower incidence of ...

Breast-milk Enema Administration to Stimulate Passage of ...

In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to ...

Lipid enemas for meconium evacuation in preterm infants

Enemas are used in preterm infants to promote meconium evacuation, but frequent high-volume enemas might contribute to focal intestinal ...

Clinical effects of breast milk on enema-induced meconium ...

Studies have shown that breast milk has appropriate osmotic pressure and high safety in stimulating the digestive tract in infants. Therefore, we aimed to ...

Breast Milk Enema Helps Preterm Infants Pass Meconium

A breast milk enema resulted in faster meconium evacuation and a shorter time to enteral feeding compared with a saline enema, a randomized clinical trial in a ...

Breast Milk Enema and Meconium Evacuation Among ...

Consequently, the confirmed safety of breast milk enemas ... The data safety monitoring committee will monitor any safety issues that occur during.