Health BehaviorNCT02912585
Oropharyngeal Administration of Colostrum
A study testing Oropharyngeal administration of own mother's colostrum and Oropharyngeal administration of donor human milk in people with Health Behavior, run by Federal University of Uberlandia.
Trial summary
Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. Read more about this study
- Who is it for?
- Ages 72 hours to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Oropharyngeal administration of own mother's colostrum and Oropharyngeal administration of donor human milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jul 2016
- 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 72 hours to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight < 1500 g and gestational age < 34 weeks
Who cannot join
- congenital anomalies
- gastrointestinal disorders
- maternal history of substance abuse or positive maternal HIV status.
About this study
Official title: Oropharyngeal Administration of Colostrum and Prevention of Infections in Very Low Birthweight Infants
Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. However, clinical instability of the preterm newborn in the first days of life results in delayed initiation of enteral nutrition. Thus, alternative methods for colostrum administration have been investigated, such as oropharyngeal administration with evidence that would be safe and feasible to perform in children admitted to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth weight preterm infants.
Read the detailed description
Background: Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. However, clinical instability of the preterm newborn in the first days of life results in delayed initiation of enteral nutrition. Thus, alternative methods for colostrum administration have been investigated, such as oropharyngeal administration with evidence that would be safe and feasible to perform in children admitted to the NICU in the first hours of life.
Objective: To evaluate the immune stimulatory effect of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth weight preterm infants.
Methods: This was a prospective, randomized and blind study that included infants less than 34 weeks gestational age and birth weight less than 1,500 g, from 15 July 2013 to 15 July 2015.
The babies were divided initially into two groups for oropharyngeal administration or not of mother's own milk: Group 1 - underwent oropharyngeal administration of mother's own milk of and Group 2 - underwent oropharyngeal administration of sterile water, considered an inert substance. Newborns who were drawn to the Group 1 and it was not possible to obtain sufficient mother's own milk volume constituted a third group called Group 3 that receive oropharyngeal administration of donor breast milk. Oropharyngeal administration were initiated within the first 48-72 hours of life and maintained for 48 hours. Before the oropharyngeal administration, 24 hours after and 14 days after, samples of blood and urine were collected from the newborns to IgA and lactoferrin dosage.
- Conditions
- Health Behavior
- Being tested
- Oropharyngeal administration of own mother's colostrum, Oropharyngeal administration of sterile water (placebo), Oropharyngeal administration of donor human milk
- Keywords
- colostrum
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal administration of own mother's colostrumBiological
Also called OMC Group
Oropharyngeal administration of sterile water (placebo)Other
Also called Placebo Group
Oropharyngeal administration of donor human milkBiological
Also called DHM Group
| Study group | Role | What they receive |
|---|---|---|
| Own mother's colostrum | Experimental | Oropharyngeal administration of own mother's colostrum. Receives: Biological: Oropharyngeal administration of own mother's colostrum |
| Placebo | Placebo comparator | Oropharyngeal administration of sterile water. Receives: Other: Oropharyngeal administration of sterile water (placebo) |
| Donor human milk | Active comparator | Oropharyngeal administration of donor human milk. Receives: Biological: Oropharyngeal administration of donor human milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of late-onset sepsis
Number of participants with late-onset sepsis
Measured: an average of 3 months
Measurement of immunologic factors in urine and blood samples using enzyme-linked immunoassay (ELISA).
ELISA Index of immunologic factors in urine and blood samples
Measured: an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Daniela Marques de Lima Mota Ferreira, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912585
- Sponsor's protocol ID
- CEP 333.886
- Status last verified
- Sep 2016
- First submitted
- 27 Jul 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ferreira DMLM, Oliveira AMM, de Leves DV, de Bem EB, Fatureto GG, Navarro NF, Afonso NG, Santiago FM, Mineo JR, Sopelete MC, Martinez FE, Bernardino Neto M, Abdallah VOS. Randomized Controlled Trial of Oropharyngeal Colostrum Administration in Very-low-birth-weight Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Jul;69(1):126-130. doi: 10.1097/MPG.0000000000002356.
PubMed 30964820
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Administration of Colostrum and Prevention of Infections in Very Low Birthweight Infants
- ClinicalTrials.gov ID
- NCT02912585
- Acronym / sponsor ID
- CEP 333.886
- Conditions
- Health Behavior
- Keywords
- colostrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Sep 2016 (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.
Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. However, clinical instability of the preterm newborn in the first days of life results in delayed initiation of enteral nutrition. Thus, alternative methods for colostrum administration have been investigated, such as oropharyngeal administration with evidence that would be safe and feasible to perform in children admitted to the NICU in the first hours of life. Objective: To evaluate the immune stimulatory effect of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth weight preterm infants.
Detailed description
Background: Infections are the main causes of morbidity and mortality in very low birth weight infants. Use of mother's own breast milk in feeding these babies is associated with a decreased risk of acquiring nosocomial infection. This protective effect is assigned to a plurality of immune components in human milk. However, clinical instability of the preterm newborn in the first days of life results in delayed initiation of enteral nutrition. Thus, alternative methods for colostrum administration have been investigated, such as oropharyngeal administration with evidence that would be safe and feasible to perform in children admitted to the NICU in the first hours of life.
Objective: To evaluate the immune stimulatory effect of oropharyngeal administration of colostrum in the incidence of sepsis in very low birth weight preterm infants.
Methods: This was a prospective, randomized and blind study that included infants less than 34 weeks gestational age and birth weight less than 1,500 g, from 15 July 2013 to 15 July 2015.
The babies were divided initially into two groups for oropharyngeal administration or not of mother's own milk: Group 1 - underwent oropharyngeal administration of mother's own milk of and Group 2 - underwent oropharyngeal administration of sterile water, considered an inert substance. Newborns who were drawn to the Group 1 and it was not possible to obtain sufficient mother's own milk volume constituted a third group called Group 3 that receive oropharyngeal administration of donor breast milk. Oropharyngeal administration were initiated within the first 48-72 hours of life and maintained for 48 hours. Before the oropharyngeal administration, 24 hours after and 14 days after, samples of blood and urine were collected from the newborns to IgA and lactoferrin dosage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Own mother's colostrum | Experimental | Biological: Oropharyngeal administration of own mother's colostrumOropharyngeal administration of own mother's colostrum. |
| Placebo | Placebo comparator | Other: Oropharyngeal administration of sterile water (placebo)Oropharyngeal administration of sterile water. |
| Donor human milk | Active comparator | Biological: Oropharyngeal administration of donor human milkOropharyngeal administration of donor human milk. |
Who may qualify
- Ages
- 72 hours to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birth weight < 1500 g and gestational age < 34 weeks
Key exclusion criteria (3 listed)
- congenital anomalies
- gastrointestinal disorders
- maternal history of substance abuse or positive maternal HIV status.
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 administration of own mother's colostrumAlso: OMC Group | Biological | Own mother's colostrum |
| Oropharyngeal administration of sterile water (placebo)Also: Placebo Group | Other | Placebo |
| Oropharyngeal administration of donor human milkAlso: DHM Group | Biological | Donor human milk |
Primary outcome
Incidence of late-onset sepsis
Time frame: an average of 3 months
Number of participants with late-onset sepsis
Measurement of immunologic factors in urine and blood samples using enzyme-linked immunoassay (ELISA).
Time frame: an average of 3 months
ELISA Index of immunologic factors in urine and blood samples
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 23 Sep 2016.
- Derived from this study: PubMed 30964820Ferreira DMLM, Oliveira AMM, de Leves DV, de Bem EB, Fatureto GG, Navarro NF, Afonso NG, Santiago FM, Mineo JR, Sopelete MC, Martinez FE, Bernardino Neto M, Abdallah VOS. Randomized Controlled Trial of Oropharyngeal Colostrum Administration in Very-low-birth-weight Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Jul;69(1):126-130. doi: 10.1097/MPG.0000000000002356.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal administration of own mother's colostrum and Oropharyngeal administration of donor human milk in people with Health Behavior, run by Federal University of Uberlandia.
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 3 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 late-onset sepsis (time frame: an average of 3 months). The study lists 2 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 NCT02912585, which also lists 1 linked publication.
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 Sep 2016.