Breast-milkPhase 1BEAMNCT07661992
Breast-milk Enema Administration to Stimulate Passage of Meconium
A Phase 1 study testing breast milk in people with Breast-milk, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Breast-milk
- What is being tested?
- breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born at >23 and <28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.
- postnatal age >48 hours, absence of spontaneous passage of meconium by >48 hours of life
- availability of mother's own milk
- written informed consent obtained from a parent or legal guardian.
Who cannot join
- Infants with Necrotizing Enterocolitis (NEC) ≥ stage II
- spontaneous intestinal perforation (SIP)
- gastrointestinal or anorectal malformations
- infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs
- significant hematologic abnormalities such as neutropenia or thrombocytopenia.
- Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Monica C Gierbolini Collazo, MD, 787-239-6289, monica.gierbolinicollazo@advocatehelth.org,
About this study
Official title: Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications
Read the detailed description
Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium. The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants. In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC. A small-volume rectal enemas using mother's own breast milk in preterm infants born at <28 weeks' gestation with delayed passage of meconium (>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.
- Conditions
- Breast-milk
- Being tested
- breast milk
- Keywords
- Meconium, rectal enemas, low birth weight infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milkDrug
A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| breast milk | Experimental | A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated. The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer. Receives: Drug: breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate
Measured: Day 1
Protocol adherence rate
Protocol adherence rate
Measured: Day 1
Incidence of necrotizing enterocolitis (NEC)
Incidence of necrotizing enterocolitis (NEC)
Measured: Day 14
Incidence of culture proven sepsis
Incidence of culture proven sepsis
Measured: Day 7
Incidence of rectal or gastrointestinal injury
Incidence of rectal or gastrointestinal injury - Rectal trauma will be assessed clinically by the presence of bleeding, fissure, or other visible anorectal injury on physical examination.
Measured: Day 7
Secondary outcomes (5)
Time to achieve full enteral feeds
Enteral feeds (enteral nutrition or tube feeding) times
Measured: Day 14
Duration of parenteral nutrition
Parenteral nutrition (PN) is a method of delivering essential nutrients directly into the bloodstream through an intravenous (IV) catheter.
Measured: Day 14
Time to first stool following intervention
Time to first stool following intervention
Measured: Day 7
Total length of hospital stay
Total length of hospital stay
Measured: Day 120
Number of central line days
Number of central line days
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast-milkStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Preterm infants born at \>23 0/7 and \<28 0/7 weeks' gestational age
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo J Rodriquez, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661992
- Sponsor's protocol ID
- IRB00150290
- Acronym
- BEAM
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
- ClinicalTrials.gov ID
- NCT07661992
- Acronym / sponsor ID
- BEAM / IRB00150290
- Conditions
- Breast-milk
- Keywords
- Meconium, rectal enemas, low birth weight infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications
Detailed description
Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium. The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants. In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC. A small-volume rectal enemas using mother's own breast milk in preterm infants born at <28 weeks' gestation with delayed passage of meconium (>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Preterm infants born at >23 0/7 and <28 0/7 weeks' gestational age
| Arm | Type | Receives |
|---|---|---|
| breast milk | Experimental | Drug: breast milkA small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated. The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer. |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born at >23 and <28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.
- postnatal age >48 hours, absence of spontaneous passage of meconium by >48 hours of life
- availability of mother's own milk
- written informed consent obtained from a parent or legal guardian.
Key exclusion criteria (6 listed)
- Infants with Necrotizing Enterocolitis (NEC) ≥ stage II
- spontaneous intestinal perforation (SIP)
- gastrointestinal or anorectal malformations
- infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs
- significant hematologic abnormalities such as neutropenia or thrombocytopenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breast milkA small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated. | Drug | breast milk |
Primary outcome
Recruitment rate
Time frame: Day 1
Recruitment rate
Protocol adherence rate
Time frame: Day 1
Protocol adherence rate
Incidence of necrotizing enterocolitis (NEC)
Time frame: Day 14
Incidence of necrotizing enterocolitis (NEC)
Incidence of culture proven sepsis
Time frame: Day 7
Incidence of culture proven sepsis
Incidence of rectal or gastrointestinal injury
Time frame: Day 7
Incidence of rectal or gastrointestinal injury - Rectal trauma will be assessed clinically by the presence of bleeding, fissure, or other visible anorectal injury on physical examination.
5 secondary outcomes
Time to achieve full enteral feeds
Time frame: Day 14
Duration of parenteral nutrition
Time frame: Day 14
Time to first stool following intervention
Time frame: Day 7
Total length of hospital stay
Time frame: Day 120
Number of central line days
Time frame: Day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ricardo J Rodriquez, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing breast milk in people with Breast-milk, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica C Gierbolini Collazo, MD (787-239-6289, monica.gierbolinicollazo@advocatehelth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.