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Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study
Camilla da Cruz Martins1, Michelle de Santana Xavier Ramos2, Mara Viana Cardoso Amaral3
1State University of Feira de Santana, Av. Transnordestina, s/n - Novo Horizonte, CEP: 44036-900, Feira de Santana, Bahia, Brazil. martinsmilla@hotmail.com.
Insights
Oropharyngeal colostrum immunotherapy is a feasible strategy for very low birth weight preterm newborns, offering immunoprotection via lymphoid tissue absorption. This study details its implementation and algorithm in a public hospital setting.
Area of Science:
- Neonatal immunology
- Clinical trial methodology
- Public health interventions
Background:
- Oropharyngeal colostrum administration is a potential neonatal health strategy due to immunoprotective component absorption by oropharyngeal lymphoid tissues.
- This study focuses on implementing and evaluating oropharyngeal colostrum immunotherapy for very low birth weight preterm infants within a neonatal unit.
Purpose of the Study:
- To describe the implementation of oropharyngeal colostrum immunotherapy in very low birth weight preterm newborns.
- To test a clinical care algorithm for this intervention in a public hospital setting.
Main Methods:
- A non-randomized superiority clinical trial with a historical control group was employed.
- The intervention involved administering 0.2 mL of raw colostrum to the oropharyngeal mucosa every 24 hours until the 7th day of life.
- Statistical analyses included t-tests, Wilcoxon's test, chi-square tests, Fisher's exact test, and survival analysis, with nutritional status assessed using Intergrowth-21st curves.
Main Results:
- The study describes the systematic implementation of oropharyngeal colostrum immunotherapy.
- An algorithm was developed to streamline and standardize the protocol's application in a public hospital.
- The discussion highlights the feasibility and benefits of the protocol in organizing clinical care and team workflow.
Conclusions:
- Oropharyngeal colostrum immunotherapy is a plausible and implementable strategy for very low birth weight preterm infants.
- The developed algorithm facilitates systematic care, improves workflow, and ensures consistent quality.
- This approach demonstrates the feasibility of oropharyngeal colostrum immunotherapy in resource-limited public hospital settings.
Background:
The oropharyngeal colostrum administration protocol to treat premature newborns is a possible and plausible strategy in neonatal health services, since the immunoprotective components of colostrum can be absorbed by the lymphoid tissues of the oropharynx. In this context, this study aims to describe the implementation of oropharyngeal colostrum immunotherapy in very low birth weight preterm newborns in a neonatal unit, as well as to test an algorithm in a public hospital.
Methods:
The protocol is applied in a non-randomized, superiority clinical trial with historical control. In the treatment group, 0.2 mL of raw colostrum is dripped into the right and left oropharyngeal mucosa, totaling 8 administrations every 24 h until the 7th complete day of life interruptedly. The control group consists of very low birth weight preterm newborns born in the same hospital in previous years (historical control). The clinical progression of 60 newborns until hospital discharge is recorded on standardized forms. A total of 350 participants are estimated to complete the survey in 4 years. The occurrence of continuous outcomes between the groups are compared through the paired t-test or Wilcoxon's two-sample test. The chi-square test or Fisher's exact test, and survival analysis are used for binary outcomes. The nutritional status is assessed through Intergrowth-21st growth curves for preterm newborns.
Discussion:
The flows of the protocol's actions is sorted by an algorithm, compatible with the Brazilian reality of a public hospital. This measure facilitates and systematizes clinical care, organizes the team's work process, speeds up the intervention steps, standardizes decision-making and unifies the quality of care, besides showing the feasibility of oropharyngeal colostrum immunotherapy.
Trial Registration:
ReBEC, U1111-1222-0598 , Registered 09 October 2018, http://www.ensaiosclinicos.gov.br/rg/RBR-2cyp7c/ .
