Immune System DiseasesPhase 3NCT03578341
Oral Colostrum and Its Effect on Immune System
A Phase 3 study testing Orally Colostrum in people with Immune System Diseases and Premature Infant Disease, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 2 sites in Mexico.
Trial summary
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo Read more about this study
- Who is it for?
- Ages 12 to 36 hours
- Conditions the study is for
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- What is being tested?
- Orally Colostrum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 3
- 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 12 to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NEWBORN 32 Gestational weeks
- Hospitalized in neonatal intensive care Unit
- Agreement signed by the legal representative
Who cannot join
- Intraventricular haemorrhage II/IV grade
- Congenital sepsis (early sepsis)
- Congenital malformations
- Early transfusions
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Guadalupe del Carmen Estrada-Gutierrez
Miguel Hidalgo, Mexico City, 11000
Silvia Romero-Maldonado
Miguel Hidalgo, Mexico City, 11000
About this study
Official title: Effect of Early Oral Colostrum Administration Versus Placebo on the Immune System in Premature Newborns Under 32 Weeks of Gestation: A Randomized Clinical Trial.
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
Read the detailed description
Prematurity is a public health problem because premature newborns have an immature immune system. Breast milk (colostrum) contains bioactive components that provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions. These bioactive components are in higher concentrations in mothers' colostrum of premature babies. Because of the morbidities presented by premature infants, they remain fasting and lack the potential benefit provided by colostrum. When the colostrum is placed in the oropharyngeal mucosa, the immunocompetent cells stimulate the immune system, increasing the serum concentrations of immunoglobulins.
Objectives: To determine the efficacy of early administration of colostrum in the oropharyngeal mucosa in preterm infants less than 32 weeks of gestation and its effect on the immune system by quantifying immunoglobulins in preterm infants born at the National Institute of Perinatology. .
Methods / Design: 1 year, double blind randomized controlled clinical trial. The newborns included will be randomly assigned to one of the 2 groups: Group 1:, newborns receiving colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
Newborns from Block B will receive orally sterile water (placebo) 0.3 mL following the same protocol. Serum immunoglobulin A, M and G concentrations will be determined before the start of the study on day 0 of life and after 7 and 28 days of life. They will continue in time until 36 SDG or at discharge, whichever comes first.
- Being tested
- Orally Colostrum
- Keywords
- Immunoglobulins A, G and M, Neonatal Sepsis, Human Milk, Orally Colostrum
- Medical subject headings
- Immune System Diseases, Agammaglobulinemia, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orally ColostrumBiological
Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum | Experimental | Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days. Receives: Biological: Orally Colostrum |
| Placebo | Placebo comparator | Group 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days. Receives: Biological: Orally Colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of serum Immunoglobulins
Quantification of immunoglobulins IgA, IgG and IgM
Measured: From baseline to day 7
Secondary outcomes (3)
sepsis neonatal
Frequency of neonatal sepsis
Measured: 28 days of postnatal age
Necrotising Enterocolitis
Frequency of neonatal
Measured: 28 days of postnatal age
Quantification of serum Immunoglobulins
Quantification of immunoglobulins IgA, IgG and IgM
Measured: From baseline to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 Immune System DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Intervention Model Description: The Participants will be randomly and assigned to Group 1, or Group 2 . using a table of random numbers, generated by a computer. The Human Milk Bank Staff, will prepares the colostrum and water (placebo) doses in syringes in such a way that it is not detected that it contains each of them, . Group 1: Will receive 0.3 mL orally colostrum every 4 h during three days, Group 2: will receive 0.3 mL orally Sterile water. Serum immunoglobulins A, G and M concentration will be determined before de start the orally doses, day 7 and 28 days of life.he nurse in charge of the patient's care, administer the dose, a doctor will take the laboratory exams and another researcher will collect and analyze the data. The syringes will be covered, to prevent the patiente´s nurse from observing the contents.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Martha Morelos-Gonzalez, Chem, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesDiana M Soriano-Becerril, MSc, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesJorge A Cardona-Pérez, MD, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesAraceli Montoya-Estrada, PhD, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesElsa Castro-Millán, Thec, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesEnrique Segura -Cervantes, MSc, Study chair, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578341
- Sponsor's protocol ID
- 212250-2320-10305-01-16
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients will be registered in a SPSS database
Publications
Romero-Maldonado S, Soriano-Becerril DM, Garcia-May PK, Reyes-Munoz E, Munoz-Ortiz EG, Carrera-Muinos S, Granados-Cepeda ML, Cardona-Perez JA, Castro-Millan E, Segura-Cervantes E, Ceballos G, Montoya-Estrada A. Effect of Oropharyngeal Administration of Colostrum in Premature Newborns </=32 Weeks of Gestation on the Immune Response and Neonatal Morbidity: A Double-Blind Randomized Clinical Trial. Front Pediatr. 2022 Jul 8;10:891491. doi: 10.3389/fped.2022.891491. eCollection 2022.
PubMed 35874579
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Oral Colostrum Administration Versus Placebo on the Immune System in Premature Newborns Under 32 Weeks of Gestation: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03578341
- Acronym / sponsor ID
- 212250-2320-10305-01-16
- Keywords
- Immunoglobulins A, G and M, Neonatal Sepsis, Human Milk, Orally Colostrum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Jul 2018 (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.
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
Detailed description
Prematurity is a public health problem because premature newborns have an immature immune system. Breast milk (colostrum) contains bioactive components that provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions. These bioactive components are in higher concentrations in mothers' colostrum of premature babies. Because of the morbidities presented by premature infants, they remain fasting and lack the potential benefit provided by colostrum. When the colostrum is placed in the oropharyngeal mucosa, the immunocompetent cells stimulate the immune system, increasing the serum concentrations of immunoglobulins.
Objectives: To determine the efficacy of early administration of colostrum in the oropharyngeal mucosa in preterm infants less than 32 weeks of gestation and its effect on the immune system by quantifying immunoglobulins in preterm infants born at the National Institute of Perinatology. .
Methods / Design: 1 year, double blind randomized controlled clinical trial. The newborns included will be randomly assigned to one of the 2 groups: Group 1:, newborns receiving colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
Newborns from Block B will receive orally sterile water (placebo) 0.3 mL following the same protocol. Serum immunoglobulin A, M and G concentrations will be determined before the start of the study on day 0 of life and after 7 and 28 days of life. They will continue in time until 36 SDG or at discharge, whichever comes first.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention Model Description: The Participants will be randomly and assigned to Group 1, or Group 2 . using a table of random numbers, generated by a computer. The Human Milk Bank Staff, will prepares the colostrum and water (placebo) doses in syringes in such a way that it is not detected that it contains each of them, . Group 1: Will receive 0.3 mL orally colostrum every 4 h during three days, Group 2: will receive 0.3 mL orally Sterile water. Serum immunoglobulins A, G and M concentration will be determined before de start the orally doses, day 7 and 28 days of life.he nurse in charge of the patient's care, administer the dose, a doctor will take the laboratory exams and another researcher will collect and analyze the data. The syringes will be covered, to prevent the patiente´s nurse from observing the contents.
| Arm | Type | Receives |
|---|---|---|
| Colostrum | Experimental | Biological: Orally ColostrumGroup 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days. |
| Placebo | Placebo comparator | Biological: Orally ColostrumGroup 2: (Placebo): Preterm newborns under 32 SDG who will receive orally sterile water 0.3 mL every 4 h during three days. |
Who may qualify
- Ages
- 12 to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- NEWBORN 32 Gestational weeks
- Hospitalized in neonatal intensive care Unit
- Agreement signed by the legal representative
Key exclusion criteria (4 listed)
- Intraventricular haemorrhage II/IV grade
- Congenital sepsis (early sepsis)
- Congenital malformations
- Early transfusions
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 |
|---|---|---|
| Orally ColostrumGroup 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days. | Biological | Colostrum, Placebo |
Primary outcome
Quantification of serum Immunoglobulins
Time frame: From baseline to day 7
Quantification of immunoglobulins IgA, IgG and IgM
3 secondary outcomes
sepsis neonatal
Time frame: 28 days of postnatal age
Necrotising Enterocolitis
Time frame: 28 days of postnatal age
Quantification of serum Immunoglobulins
Time frame: From baseline to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 35874579Romero-Maldonado S, Soriano-Becerril DM, Garcia-May PK, Reyes-Munoz E, Munoz-Ortiz EG, Carrera-Muinos S, Granados-Cepeda ML, Cardona-Perez JA, Castro-Millan E, Segura-Cervantes E, Ceballos G, Montoya-Estrada A. Effect of Oropharyngeal Administration of Colostrum in Premature Newborns </=32 Weeks of Gestation on the Immune Response and Neonatal Morbidity: A Double-Blind Randomized Clinical Trial. Front Pediatr. 2022 Jul 8;10:891491. doi: 10.3389/fped.2022.891491. eCollection 2022.
- Individual participant dataSharing planned: Yes. Patients will be registered in a SPSS database
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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.
Martha Morelos-Gonzalez, Chem study chair
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Diana M Soriano-Becerril, MSc study chair
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Jorge A Cardona-Pérez, MD study chair
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orally Colostrum in people with Immune System Diseases and Premature Infant Disease, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 2 sites in Mexico.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Quantification of serum Immunoglobulins (time frame: From baseline to day 7). 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 NCT03578341, 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 2 Oct 2019.