InfectionNCT02116699
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
A study testing oropharyngeal mother's milk and oropharyngeal sterile water in people with Infection and Enterocolitis, Necrotizing, run by Endeavor Health at 5 sites in United States.
Trial summary
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the… Read more about this study
- Who is it for?
- Ages 1 day to 4 days
- Conditions the study is for
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- What is being tested?
- oropharyngeal mother's milk and oropharyngeal sterile water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Nov 2013to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 4 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight <1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life
Who cannot join
- Gastrointestinal anomaly pH < 7.0 on initial blood gas in NICU Maternal +HIV status Maternal drug or substance use that precludes infant from receiving mother's milk Tracheoesophageal fistula
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
NorthShore University health System
Evanston, Illinois, 60201
South Miami Hospital
Miami, Florida, 33143-4679
Morristown Medical Center
Morristown, New Jersey, 07960
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Betty Cameron Women & Children's Hospital
Wilmington, North Carolina, 28403-6024
About this study
Official title: Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.
Read the detailed description
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. This 5-year placebo-controlled, double-blind randomized controlled trial will evaluate the safety, efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622 (total patients enrolled) extremely premature infants with the following aims: Aim 1. To determine if oropharyngeal administration of OMC/OMM to extremely premature infants will reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2: To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3: To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal) microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin. Results will confirm whether extremely premature infants demonstrate a host-immune response to this intervention and whether there is a beneficial effect on common morbidities in these high risk patients.
- Being tested
- oropharyngeal mother's milk, oropharyngeal sterile water
- Keywords
- oropharyngeal, colostrum, mother's milk, premature, neonate, infection, necrotizing enterocolitis, ventilator-associated pneumonia, breastmilk, human milk, late-onset sepsis, microbiome, antioxidant, enteral feeds
- Medical subject headings
- Infections, Enterocolitis, Necrotizing, Pneumonia, Ventilator-Associated, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oropharyngeal mother's milkOther
Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
oropharyngeal sterile waterOther
Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
| Study group | Role | What they receive |
|---|---|---|
| oropharyngeal mother's milk | Experimental | 0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age Receives: Other: oropharyngeal mother's milk |
| oropharyngeal sterile water | Placebo comparator | 0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age Receives: Other: oropharyngeal sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of of late-onset sepsis
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
Measured: at 40 wks CGA
Incidence of necrotizing enterocolitis
defined according to modified Bell's criteria stage >2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas
Measured: at 40 weeks CGA
Incidence of ventilator-associated pneumonia
Measured: at 40 weeks CGA
Secondary outcomes (5)
Time to reach full enteral feeds
defined as # days to reach a 120kcal/kg/day
Measured: at 40 wks CGA
Length of hospital stay
Measured: at 40 wks CGA
Concentrations of lactoferrin in urine
Measured: 1 day, 3 days, 32 weeks CGA
Changes in stool microbiome
Measured: 3 days, 2 weeks, 32 weeks CGA
Changes in urinary biomarkers of oxidative stress
1 day, 3 days, 1 week, 32 weeks CGA
Measured: 3 days,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study start20 Nov 2013
- Primary completion30 Oct 2021
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation, Fundacion Para La Investigacion Hospital La Fe, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Nancy A Garofalo (previously Rodriguez), PhD APN NNP, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116699
- Sponsor's protocol ID
- EH11-360
- Status last verified
- Feb 2023
- First submitted
- 11 Apr 2014
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Rodriguez NA, Moya F, Ladino J, Zauk A, Prazad P, Perez J, Vento M, Claud E, Wang CH, Caplan MS. A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants. J Perinatol. 2023 May;43(5):601-607. doi: 10.1038/s41372-022-01589-x. Epub 2023 Jan 3.
PubMed 36596945Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.
PubMed 26458907
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Administration of Mother's Colostrum: Health Outcomes of Premature Infants
- ClinicalTrials.gov ID
- NCT02116699
- Acronym / sponsor ID
- EH11-360
- Keywords
- oropharyngeal, colostrum, mother's milk, premature, neonate, infection, necrotizing enterocolitis, ventilator-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- The Gerber Foundation, Fundacion Para La Investigacion Hospital La Fe, University of Chicago
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 17 Apr 2014 (estimated)
- 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.
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. The investigators hypothesize that infants who receive oropharyngeal mother's colostrum and milk will have significantly lower rates of infection and improved health outcomes, compared to infants who receive a placebo.
Detailed description
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide immunostimulatory effects when administered oropharyngeally to extremely premature infants during the first weeks of life. This 5-year placebo-controlled, double-blind randomized controlled trial will evaluate the safety, efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622 (total patients enrolled) extremely premature infants with the following aims: Aim 1. To determine if oropharyngeal administration of OMC/OMM to extremely premature infants will reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2: To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3: To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal) microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin. Results will confirm whether extremely premature infants demonstrate a host-immune response to this intervention and whether there is a beneficial effect on common morbidities in these high risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oropharyngeal mother's milk | Experimental | Other: oropharyngeal mother's milk0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age |
| oropharyngeal sterile water | Placebo comparator | Other: oropharyngeal sterile water0.2 mL every 2 hours for 48 hours beginning within 96 hours post-birth, followed by 0.2 mL every 3 hours until 32 weeks post conceptional age |
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birthweight <1250g Mother plans to pump and provide breastmilk for at least 2 months Absence of severe congenital anomalies Admission to the neonatal intensive care unit within 24 hours after birth Ability to begin protocol within 96 hours of life
Key exclusion criteria (1 listed)
- Gastrointestinal anomaly pH < 7.0 on initial blood gas in NICU Maternal +HIV status Maternal drug or substance use that precludes infant from receiving mother's milk Tracheoesophageal fistula
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 |
|---|---|---|
| oropharyngeal mother's milkApplication of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age | Other | oropharyngeal mother's milk |
| oropharyngeal sterile waterApplication of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age | Other | oropharyngeal sterile water |
Primary outcome
Incidence of of late-onset sepsis
Time frame: at 40 wks CGA
positive blood cultures (not deemed contaminated) collected after 72 hours of age, and 2 clinical symptoms
Incidence of necrotizing enterocolitis
Time frame: at 40 weeks CGA
defined according to modified Bell's criteria stage >2 with clinical signs and radiological evidence of pneumatosis intestinalis or portal venous gas
Incidence of ventilator-associated pneumonia
Time frame: at 40 weeks CGA
5 secondary outcomes
Time to reach full enteral feeds
Time frame: at 40 wks CGA
Length of hospital stay
Time frame: at 40 wks CGA
Concentrations of lactoferrin in urine
Time frame: 1 day, 3 days, 32 weeks CGA
Changes in stool microbiome
Time frame: 3 days, 2 weeks, 32 weeks CGA
Changes in urinary biomarkers of oxidative stress
Time frame: 3 days,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 36596945Rodriguez NA, Moya F, Ladino J, Zauk A, Prazad P, Perez J, Vento M, Claud E, Wang CH, Caplan MS. A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants. J Perinatol. 2023 May;43(5):601-607. doi: 10.1038/s41372-022-01589-x. Epub 2023 Jan 3.
- Derived from this study: PubMed 26458907Rodriguez NA, Vento M, Claud EC, Wang CE, Caplan MS. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:453. doi: 10.1186/s13063-015-0969-6.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Nancy A Garofalo (previously Rodriguez), PhD APN NNP principal investigator
Endeavor Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oropharyngeal mother's milk and oropharyngeal sterile water in people with Infection and Enterocolitis, Necrotizing, run by Endeavor Health at 5 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of of late-onset sepsis (time frame: at 40 wks CGA). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02116699, which also lists 2 linked publications.
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 1 Mar 2023.