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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colostrum | Experimental | Group 1:(Colostrum): Preterm infants under 32 SDG will receive orally colostrum 0.3 mL every 4 h during three days. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orally Colostrum | Biological | Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of serum Immunoglobulins | Quantification of immunoglobulins IgA, IgG and IgM | From baseline to day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| sepsis neonatal | Frequency of neonatal sepsis | 28 days of postnatal age |
| Necrotising Enterocolitis | Frequency of neonatal | 28 days of postnatal age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Morelos-Gonzalez, Chem | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Diana M Soriano-Becerril, MSc | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Jorge A Cardona-PƩrez, MD | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Araceli Montoya-Estrada, PhD | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Elsa Castro-MillƔn, Thec | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Enrique Segura -Cervantes, MSc | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guadalupe del Carmen Estrada-Gutierrez | Miguel Hidalgo | Mexico City | 11000 | Mexico | ||
| Silvia Romero-Maldonado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35874579 | Derived | 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. |
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Patients will be registered in a SPSS database
The Data will be available in 2019, after the protocol is finished, for a month
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000361 | Agammaglobulinemia |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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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.
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Masking Description: The colostrum and placebo will be preparing by a Human Milk Bank person, who will be knowing the treatment of both 2nd and 1st group. Both colostrum and placebo, will be administrating by nursing staff in syringes in such a way that it is not detected that it contains each of them. Neither the parents of the participants nor the researchers will be involved in the care or analysis of the data, until the end of the study.
| Quantification of serum Immunoglobulins | Quantification of immunoglobulins IgA, IgG and IgM | From baseline to day 28 |
| Miguel Hidalgo |
| Mexico City |
| 11000 |
| Mexico |
| D008206 | Lymphatic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |